Pharma Reviews: April 2020

Thursday, April 30, 2020

Pharma Reviews: Glenmark to Conduct Trials for Potential Covid-19 Drug, Shares Jump

On Wednesday, another Indian pharmaceutical company, Strides Pharma Science Ltd, said it had developed and commercialised favipiravir antiviral ...
Read more: Glenmark to Conduct Trials for Potential Covid-19 Drug, Shares Jump

Pharma Reviews: India recovery divides stock traders on which sectors to bet on

“Indian pharmaceutical companies had a lot of issues with the U.S. FDA. After the crisis hit, there were several approvals for plants to reopen,” Gopani ...
Read more: India recovery divides stock traders on which sectors to bet on

US FDA News: Coronavirus (COVID-19) Update: Daily Roundup April 30, 2020

Coronavirus (COVID-19) Update: Daily Roundup
Read more: Coronavirus (COVID-19) Update: Daily Roundup April 30, 2020

US FDA News: Coronavirus (COVID-19) Update: FDA Includes Ventilator Developed by NASA in Ventilator Emergency Use Authorization

Coronavirus (COVID-19) Update: FDA Includes Ventilator Developed by NASA in Ventilator Emergency Use Authorization
Read more: Coronavirus (COVID-19) Update: FDA Includes Ventilator Developed by NASA in Ventilator Emergency Use Authorization

US FDA News: Vascular Solutions, Inc. Recalls Langston Dual Lumen Catheter Due to Risk of Separation During Use

Vascular Solutions, Inc. recalled the Langston Dual Lumen catheter due to the inner catheter may separate during or after a high-pressure injection.
Read more: Vascular Solutions, Inc. Recalls Langston Dual Lumen Catheter Due to Risk of Separation During Use

Pharma Reviews: India exports 50 million hydroxychloroquine tablets to US for COVID-19 fight: Report

Teva Pharmaceutical Industries, IPCA Laboratories and Cadila Healthcare are among India's leading suppliers of hydroxychloroquine.
Read more: India exports 50 million hydroxychloroquine tablets to US for COVID-19 fight: Report

Pharma Reviews: India exports 50 mln hydroxychloroquine tablets to US for COVID-19 fight -source

The trade, India's biggest export of the drug to any country, follows a ... Teva Pharmaceutical Industries, IPCA Laboratories and Cadila Healthcare are ...
Read more: India exports 50 mln hydroxychloroquine tablets to US for COVID-19 fight -source

Pharma Reviews: Nifty Pharma index rallies nearly 30% after 21 years; smallcap stocks outperform largecaps

pharma companies will be incentivised," said Sudarshan Jain, secretary general of Indian Pharmaceutical Alliance (IPA) to IIFL Securities.
Read more: Nifty Pharma index rallies nearly 30% after 21 years; smallcap stocks outperform largecaps

Pharma Reviews: Coronavirus drug Favipiravir set for clinical trials by Indian pharma companies Strides and Glenmark

At least two Indian pharmaceutical manufacturers — Strides Pharma and Glenmark Pharmaceuticals — are set to run clinical trials for a potential ...
Read more: Coronavirus drug Favipiravir set for clinical trials by Indian pharma companies Strides and Glenmark

Pharma Reviews: COVID-19 drug ready, proved to reduce duration of infection among patients: Strides Pharma

In a statement, Strides has said it would immediately apply to Indian drug ... necessary studies and make the drug available to Indians expeditiously. ... Meanwhile, the company's stock has gained 20 per cent to Rs 449.1 on the ...
Read more: COVID-19 drug ready, proved to reduce duration of infection among patients: Strides Pharma

Pharma Reviews: Coronavirus: Glenmark to conduct trials for potential COVID-19 drug; shares jump 9%

On Wednesday, another Indian pharmaceutical company, Strides Pharma Science Ltd, said it had developed and commercialized favipiravir antiviral ...
Read more: Coronavirus: Glenmark to conduct trials for potential COVID-19 drug; shares jump 9%

Pharma Reviews: Strides Pharma share price up 26% in two days, firm starts exporting drug used on Covid-19 patients

Pharmaceutical companies have been witnessing a surge in the domestic ... Strides Pharma said that it will soon apply to Indian Drug Authorities to ...
Read more: Strides Pharma share price up 26% in two days, firm starts exporting drug used on Covid-19 patients

Pharma Reviews: India's stock market recovery divides traders on which sectors to bet on

“Indian pharmaceutical companies had a lot of issues with the U.S. FDA. After the crisis hit, there were several approvals for plants to reopen," Gopani ...
Read more: India's stock market recovery divides traders on which sectors to bet on

Wednesday, April 29, 2020

Pharma Reviews: PM Modi assures Trudeau of support from India's pharma industry; thanks for looking after Indians ...

... Narendra Modi on Tuesday conveyed his assurance to Canadian PM Justin Trudeau that India's productive capabilities in the pharmaceutical sector ...
Read more: PM Modi assures Trudeau of support from India's pharma industry; thanks for looking after Indians ...

US FDA News: CME America Provides Update on Two Previously Announced Voluntary Recalls Related to Ambulatory Infusion Pumps and Sets

CME America, a wholly owned subsidiary of BD (Becton, Dickinson and Company), a leading global medical technology company, today issued the following update regarding two previously announced voluntary recalls, one related to all models of CMEAmerica BodyGuard® infusion pumps (FDA Recall Number: Z-1
Read more: CME America Provides Update on Two Previously Announced Voluntary Recalls Related to Ambulatory Infusion Pumps and Sets

US FDA News: Coronavirus (COVID-19) Update: Daily Roundup April 29, 2020

Coronavirus (COVID-19) Update: Daily Roundup
Read more: Coronavirus (COVID-19) Update: Daily Roundup April 29, 2020

Pharma Reviews: India's pharma capabilities will remain available for assisting world: PM Modi assures Canadian ...

... on Tuesday that India's productive capabilities in the pharmaceutical sector ... On his part, Trudeau "appreciated" the support provided by the Indian ...
Read more: India's pharma capabilities will remain available for assisting world: PM Modi assures Canadian ...

Pharma Reviews: India's Pharma Capabilities Will Remain Available For Assisting World: PM Modi Assures ...

"Prime Minister conveyed the assurance that India's productive capabilities in the pharmaceutical sector would remain available for assisting the ...
Read more: India's Pharma Capabilities Will Remain Available For Assisting World: PM Modi Assures ...

US FDA News: FDA Grants Marketing of New Device for Continuous Dialysis Therapy for use in Pediatric Patients with Certain Kidney Conditions

FDA grants marketing authorization for a new device indicated to provide continuous hemodialysis or hemofiltration therapy to critically ill pediatric patients weighing between 2.5 and 10 kilograms (or 5.5 to 22 pounds)
Read more: FDA Grants Marketing of New Device for Continuous Dialysis Therapy for use in Pediatric Patients with Certain Kidney Conditions

Pharma Reviews: Lockdown: Pharma firms in TN seek six months GST holiday

TN chapter of Consortium of Indian Pharmaceutical Manufacturers and Marketers Associations has over 500 registered member companies which are ...
Read more: Lockdown: Pharma firms in TN seek six months GST holiday

Pharma Reviews: Grapevine: KKR leads race for Piramal pharma stake; Glaxo looks to sell HUL holding

KKR has previously invested in at least two Indian pharmaceutical companies—Slayback Pharma and Gland Pharma Ltd. The PE firm had put in $60 ...
Read more: Grapevine: KKR leads race for Piramal pharma stake; Glaxo looks to sell HUL holding

Pharma Reviews: Lockdown: Pharma firms in TN seek six months GST holiday

The Tamil Nadu chapter of Consortium of Indian Pharmaceutical Manufacturers and Marketers Associations (CIPMMA) claimed their business ...
Read more: Lockdown: Pharma firms in TN seek six months GST holiday

Pharma Reviews: Covid-19: Strides to seek regulator nod to sell favipiravir tablet in India

Strides has also entered into a preferred arrangement with a leading Indian manufacturer for supplies of active pharmaceutical ingredients of ...
Read more: Covid-19: Strides to seek regulator nod to sell favipiravir tablet in India

Pharma Reviews: India's Pharma Capabilities Will Remain Available For Assisting World: PM Modi Assures ...

... India's productive capabilities in the pharmaceutical sector would remain ... On his part, Trudeau "appreciated" the support provided by the Indian ...
Read more: India's Pharma Capabilities Will Remain Available For Assisting World: PM Modi Assures ...

Pharma Reviews: Vaishali Pharma stock spurts 4% after launching Personal Care and Hygiene Products

Shares of Vaishali Pharma soared 4% in the afternoon session as the company has taken a stride forward to fight against the COVID-19 pandemic by ...
Read more: Vaishali Pharma stock spurts 4% after launching Personal Care and Hygiene Products

Pharma Reviews: Strides Pharma develops Favipiravir antiviral tablets; drug shows positive outcome in COVID-19 ...

Strides has also entered into a preferred arrangement with a leading Indian API manufacturer for the supplies of Favipiravir API(active pharmaceutical ...
Read more: Strides Pharma develops Favipiravir antiviral tablets; drug shows positive outcome in COVID-19 ...

Pharma Reviews: India's Tactical Victory on HCQ

When a new drug is launched, pharma companies carry 20-year patents for the process and the product, ensuring that no other company can ...
Read more: India's Tactical Victory on HCQ

Tuesday, April 28, 2020

Pharma Reviews: Industries want to restart production in Telangana; seek power charges waiver

It also suggested that the State government start the proposed Hyderabad Pharma City as it would help the Indian pharma industry export medicines.
Read more: Industries want to restart production in Telangana; seek power charges waiver

Pharma Reviews: India's Pharma Capabilities Will Remain Available To World Against COVID-19 Fight: PM Modi

PM Modi said India's productive capabilities in the pharmaceutical sector would remain available for assisting the citizens of the world amid COVID-19.
Read more: India's Pharma Capabilities Will Remain Available To World Against COVID-19 Fight: PM Modi

US FDA News: Coronavirus (COVID-19) Update: Daily Roundup April 28, 2020

Coronavirus (COVID-19) Update: Daily Roundup
Read more: Coronavirus (COVID-19) Update: Daily Roundup April 28, 2020

Pharma Reviews: India's pharma capabilities will remain available to world to fight COVID-19: PM

New Delhi, Apr 28 (PTI) Prime Minister Narendra Modi on Tuesday said India's productive capabilities in the pharmaceutical sector would remain ...
Read more: India's pharma capabilities will remain available to world to fight COVID-19: PM

Pharma Reviews: India should ease lockdown from May 3, be fully operational by June end: Shaw

A lot of research effort is currently on with several Indian pharma companies and research institutes collaborating for developing vaccines against ...
Read more: India should ease lockdown from May 3, be fully operational by June end: Shaw

Pharma Reviews: The Indian pharmaceutical industry might be a ray of hope in the feared economic slowdown

We help the global pharmaceutical companies gain insight into the drug development trends across the industry and identify new business opportunities ...
Read more: The Indian pharmaceutical industry might be a ray of hope in the feared economic slowdown

Pharma Reviews: Virus crisis an opportunity for Indian firms to become global majors: Srinivas Rao Ravuri

We believe the rally in the pharmaceutical sector would continue as there is visibility of growth and valuations are not expensive. Also, before the recent ...
Read more: Virus crisis an opportunity for Indian firms to become global majors: Srinivas Rao Ravuri

Pharma Reviews: Post relaxation in lockdown, the focus for Pharma would be to ramp up production : Ramkumar SV

Edited excerpts: What is the impact of Covid-19 crisis on the Indian pharma industry? India has an important position in the global pharmaceutical sector ...
Read more: Post relaxation in lockdown, the focus for Pharma would be to ramp up production : Ramkumar SV

Pharma Reviews: Covid has proved we haven't spent enough on life science research. Time to make up now

Domestic pharma companies are developing drugs and vaccines. Some have also developed tests and are rolling out testing services. India's ...
Read more: Covid has proved we haven't spent enough on life science research. Time to make up now

Pharma Reviews: Meet Kripa Shanker Gupta, the man who supplied coronavirus test kits to ICMR at 145% mark-up

He claims in-depth understanding of Indian pharmaceutical and healthcare system with "successful stint in multinational pharma companies as ...
Read more: Meet Kripa Shanker Gupta, the man who supplied coronavirus test kits to ICMR at 145% mark-up

Pharma Reviews: Coronavirus outbreak propels pharma funds forward; should you invest?

Experts believe there was already a visible turnaround in the pharma sector, both ... Top reason is Indian pharma companies will have a role to play in ...
Read more: Coronavirus outbreak propels pharma funds forward; should you invest?

Pharma Reviews: US-India cooperation against COVID19

Although India is often dubbed as the “pharmacy of the world” and its pharmaceutical industry is the world's third-largest, the Narendra Modi ...
Read more: US-India cooperation against COVID19

Pharma Reviews: Avoid banks, go for healthcare, pharma and FMCG stocks: Dipan Mehta

Companies will have to answer a lot in terms of how they are going to go back ... On the medical front, what are markets pricing in because it seems India so ... Healthcare, pharmaceutical and FMCG companies will be the first to start ...
Read more: Avoid banks, go for healthcare, pharma and FMCG stocks: Dipan Mehta

Pharma Reviews: Strike when it's hot! 58% stocks from this sector defy crisis to double prices

Top pharma players like Dr Reddy's Labs, Abbott India, Divi's Labs, Biocon, Aurobindo Pharma, Sun Pharma, Mangalam Drugs, IPCA Labs, Ajanta ...
Read more: Strike when it's hot! 58% stocks from this sector defy crisis to double prices

Monday, April 27, 2020

US FDA News: Coronavirus (COVID-19) Update: Daily Roundup April 27, 2020

Coronavirus (COVID-19) Update: Daily Roundup
Read more: Coronavirus (COVID-19) Update: Daily Roundup April 27, 2020

US FDA News: Fresenius Kabi's Recall of Ketorolac Results In QuVa Pharma® Recall of Compounded Sterile Product (R.E.C.K.)

QuVa Pharma, Inc. confirms that is working with the U.S. Food and Drug Administration, and voluntarily recalling all lots of R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) 50 ml in Sodium Chloride-60 ml BD syringe that were prepared using sterile Ketorolac being recalled by Fresenius Kabi
Read more: Fresenius Kabi's Recall of Ketorolac Results In QuVa Pharma® Recall of Compounded Sterile Product (R.E.C.K.)

US FDA News: Surgical Mask and Gown Conservation Strategies - Letter to Health Care Providers

The FDA recognizes that the need for personal protective equipment (PPE), such as surgical masks, surgical and isolation gowns, and surgical suits, may outpace the supply available to health care organization during the Coronavirus Disease 2019 (COVID-19) outbreak.
Read more: Surgical Mask and Gown Conservation Strategies - Letter to Health Care Providers

US FDA News: UPDATE: Potential Risks with Liquid-filled Intragastric Balloons - Letter to Health Care Providers

FDA continues to work with the manufacturers to evaluate reports of deaths in patients with liquid-filled intragastric balloon systems used to treat obesity.
Read more: UPDATE: Potential Risks with Liquid-filled Intragastric Balloons - Letter to Health Care Providers

US FDA News: UPDATE: Potential risks with liquid-filled intragastric balloons - Letter to Health Care Providers

The FDA is issuing this update to alert health care providers of five reports of unanticipated deaths that occurred from 2016 to present in patients with liquid-filled intragastric balloon systems used to treat obesity.
Read more: UPDATE: Potential risks with liquid-filled intragastric balloons - Letter to Health Care Providers

US FDA News: The FDA alerts health care providers about potential risks with liquid-filled intragastric balloons

The FDA has recently received multiple reports for two different types of adverse events associated with liquid-filled intragastric balloons used to treat obesity. The first type of adverse event involves balloon over-inflating and the second type is development of acute pancreatitis.
Read more: The FDA alerts health care providers about potential risks with liquid-filled intragastric balloons

US FDA News: UPDATE: Potential Risks with Liquid-filled Intragastric Balloons - Letter to Health Care Providers

An update on the potential risks of over-inflation (spontaneous hyperinflation), acute pancreatitis, and deaths in patients with Orbera and ReShape liquid-filled intragastric balloons used for weight loss in adult patients with obesity.
Read more: UPDATE: Potential Risks with Liquid-filled Intragastric Balloons - Letter to Health Care Providers

US FDA News: FDA Warns Manufacturers and Retailers to Remove Certain E-cigarette Products Targeted to Youth from the Market

FDA issued ten warning letters to retailers and manufacturers who sell, manufacture and/or import unauthorized electronic nicotine delivery system (ENDS) products targeted to youth or likely to promote use by youth.
Read more: FDA Warns Manufacturers and Retailers to Remove Certain E-cigarette Products Targeted to Youth from the Market

US FDA News: Coronavirus (COVID-19) Update: FDA Continues to Ensure Availability of Alcohol-Based Hand Sanitizer During the COVID-19 Pandemic, Addresses Safety Concerns

FDA provides an update on its efforts to ensure the availability of alcohol-based sanitizer
Read more: Coronavirus (COVID-19) Update: FDA Continues to Ensure Availability of Alcohol-Based Hand Sanitizer During the COVID-19 Pandemic, Addresses Safety Concerns

Sunday, April 26, 2020

Pharma Reviews: USFDA grants EIR to Natco Pharma for Kothur facility

Indian pharmaceutical company, Natco Pharma Limited, announced that it has received an EIR for Kothur's formulation facility (Telangana). In a BSE ...
Read more: USFDA grants EIR to Natco Pharma for Kothur facility

Saturday, April 25, 2020

Pharma Reviews: Five webinars to watch out for next week

... that will focus on the Indian food processing, pharma and packaging industry ... India is rightly poised to become the global hub for manufacturing.
Read more: Five webinars to watch out for next week

Pharma Reviews: Virus should break cycle of dependence on China

Strategically, China supported its core industry at a time when India opened up ... Consequently, the pharma industry is largely dependent on Chinese ...
Read more: Virus should break cycle of dependence on China

Pharma Reviews: How India can reboot once the COVID-19 scare is over?

A Coronavirus battle involving the lockdown is bound to cripple India's ... Indian pharma industry needs to work closely with global players to find a ...
Read more: How India can reboot once the COVID-19 scare is over?

Pharma Reviews: Pharma tops sectoral indices in 2020

In April, Indian pharma companies received Establishment Inspection Reports for five manufacturing facilities. Several new drugs filings also have been ...
Read more: Pharma tops sectoral indices in 2020

Pharma Reviews: Sikkim pharma industry fully functional despite lockdown, says no shortage in domestic drugs

“We don't get revenue from the Pharma companies as according to a policy of the Indian Government, the North East Industrial Investment Promotion ...
Read more: Sikkim pharma industry fully functional despite lockdown, says no shortage in domestic drugs

Pharma Reviews: Reducing Dependency on China Imports: IICT, LAXAI LifeSciences tie-up for key pharma ...

Hyderabad: The Indian Institute of Chemical Technology, a constituent laboratory of Council of Scientific and Industrial Research, is collaborating with ...
Read more: Reducing Dependency on China Imports: IICT, LAXAI LifeSciences tie-up for key pharma ...

Pharma Reviews: Air India SATS becomes a full member of air pharma network Pharma.Aero

To be included in their network is a key milestone for AISATS as we pursue industry collaboration to aid our long-term goal of building a pharma corridor ...
Read more: Air India SATS becomes a full member of air pharma network Pharma.Aero

Pharma Reviews: Hyderabad: IICT, pharma giant to develop Covid drug

... Ingredients (APIs) and intermediates, which will go a long way to reduce the dependency of Indian pharmaceutical sector on Chinese imports.
Read more: Hyderabad: IICT, pharma giant to develop Covid drug

Pharma Reviews: 13 fresh COVID-19 cases in Telangana;State gets Centre's nod for plasma therapy

... manufacture Active Pharmaceutical Ingredients (APIs) and Intermediates to reduce the dependency of Indian Pharma sector on Chinese imports, ...
Read more: 13 fresh COVID-19 cases in Telangana;State gets Centre's nod for plasma therapy

Pharma Reviews: India gears up for patient trials on 20 different drugs for Covid-19

Pharma industry sources highlighted that companies can procure a patented drug in small quantities for research purposes. In the face of a medical ...
Read more: India gears up for patient trials on 20 different drugs for Covid-19

Pharma Reviews: Hyderabad's IICT, LAXAI Lifesciences tie-up for Covid-19 drugs

India, one of the largest producers of anti-malarial drug HCQ, has seen a spurt in ... It noted that the outbreak of Covid-19 has exposed the disproportionate reliance of the Indian pharmaceutical industry, third largest in the world by ...
Read more: Hyderabad's IICT, LAXAI Lifesciences tie-up for Covid-19 drugs

Friday, April 24, 2020

US FDA News: Coronavirus (COVID-19) Update: Daily Roundup April 24, 2020

Coronavirus (COVID-19) Update: Daily Roundup
Read more: Coronavirus (COVID-19) Update: Daily Roundup April 24, 2020

US FDA News: FDA Provides Updates on Adverse Event Reports and Postmarket Activities Associated with Essure

FDA issued a letter to Bayer outlining conditions for submitting additional postmarket information to the agency about Essure. The letter applies to reportable adverse events Bayer is or becomes aware of from social media data received in relation to litigation.
Read more: FDA Provides Updates on Adverse Event Reports and Postmarket Activities Associated with Essure

Pharma Reviews: IICT collaborates with LAXAI Lifesciences to reduce dependency on China for APIs, Key ...

Outbreak of Covid-19 has exposed the disproportionate reliance of the Indian pharmaceutical Industry, third largest in the world by the volume of drugs ...
Read more: IICT collaborates with LAXAI Lifesciences to reduce dependency on China for APIs, Key ...

Pharma Reviews: Hello! This is... | Prashant Tandon of 1mg on COVID-19 impact on e-pharma industry

... have essential services like delivery of medicines and pharmaceutical products continued uninterrupted through the nationwide lockdown in India?
Read more: Hello! This is... | Prashant Tandon of 1mg on COVID-19 impact on e-pharma industry

Pharma Reviews: Invest in private sector banks and open your eyes only after 3 years: Samir Arora

We do not believe that anything will change in Indian pharma. ... But it is not my case ever that the only good companies in India are the ones which I ...
Read more: Invest in private sector banks and open your eyes only after 3 years: Samir Arora

Pharma Reviews: Allow pharma MSMEs to export Ethanol based sanitisers to meet needs: LUB

... manufacturing to all over India MSME pharma industry units for domestic markets and exports under the lucrative norms to fulfill the needs of Indian ...
Read more: Allow pharma MSMEs to export Ethanol based sanitisers to meet needs: LUB

Pharma Reviews: CNBC-TV18 Market Highlights: Sensex falls over 500 points, Nifty ends below 9200; Bharti Infratel ...

Pharma sector remained the only one to trade in the green. ... This month, the company launched anti-cancer drug Dasahill in the Indian market, ...
Read more: CNBC-TV18 Market Highlights: Sensex falls over 500 points, Nifty ends below 9200; Bharti Infratel ...

Pharma Reviews: Tech company' sales growth to slow down to 0-2% from 6-8%: Fitch

Mumbai: The sales growth of Indian technology companies is likely to slow down to an ... Pharma: The current rally could be wiped off in a jiffy.
Read more: Tech company' sales growth to slow down to 0-2% from 6-8%: Fitch

Pharma Reviews: Coronavirus India Latest Updates: Cases in India rise to 23452; death toll at 723

Coronavirus India Latest Updates: Cases in India rise to 23,452; death toll at ... to reduce the dependency of Indian Pharma sector on Chinese imports.
Read more: Coronavirus India Latest Updates: Cases in India rise to 23452; death toll at 723

Pharma Reviews: FOCUS: Raw materials available, but transport trips Indian drugmakers

The nation-wide lockdown, which is now nearing a month, has become the biggest problem for pharmaceutical companies. Indian pharma companies ...
Read more: FOCUS: Raw materials available, but transport trips Indian drugmakers

US FDA News: Coronavirus (COVID-19) Update: FDA Reiterates Importance of Close Patient Supervision for ‘Off-Label’ Use of Antimalarial Drugs to Mitigate Known Risks, Including Heart Rhythm Problems

FDA is reiterating the importance of close patient supervision for ‘off-label’ use of antimalarial drugs to mitigate known risks, including heart rhythm problems.
Read more: Coronavirus (COVID-19) Update: FDA Reiterates Importance of Close Patient Supervision for ‘Off-Label’ Use of Antimalarial Drugs to Mitigate Known Risks, Including Heart Rhythm Problems

US FDA News: Hydroxychloroquine or Chloroquine for COVID-19: Drug Safety Communication - FDA Cautions Against Use Outside of the Hospital Setting or a Clinical Trial Due to Risk of Heart Rhythm Problems

FDA is concerned that hydroxychloroquine and chloroquine are being used inappropriately to treat non-hospitalized patients for coronavirus disease (COVID-19) or to prevent that disease.
Read more: Hydroxychloroquine or Chloroquine for COVID-19: Drug Safety Communication - FDA Cautions Against Use Outside of the Hospital Setting or a Clinical Trial Due to Risk of Heart Rhythm Problems

Thursday, April 23, 2020

US FDA News: Coronavirus (COVID-19) Update: Daily Roundup April 23, 2020

Coronavirus (COVID-19) Update: Daily Roundup
Read more: Coronavirus (COVID-19) Update: Daily Roundup April 23, 2020

US FDA News: FDA Warns Companies Illegally Selling CBD Products to Treat Medical Conditions, Opioid Addiction

FDA has issued warning letters to two companies for illegally selling unapproved products containing cannabidiol (CBD) in ways that violate the FD&C Act, including claims that they can treat medical conditions, including opioid addiction.
Read more: FDA Warns Companies Illegally Selling CBD Products to Treat Medical Conditions, Opioid Addiction

US FDA News: Coronavirus (COVID-19) Update: Court Grants FDA’s Request for Extension of Premarket Review Submission Deadline for Certain Tobacco Products Because of Impacts from COVID-19

As a result of the COVID-19 pandemic, FDA requested and was granted by the court, a 120-day extension of the May 12 deadline for premarket applications for e-cigarettes, cigars and other new tobacco products. These premarket applications are now required to be filed by Sept. 9, 2020.
Read more: Coronavirus (COVID-19) Update: Court Grants FDA’s Request for Extension of Premarket Review Submission Deadline for Certain Tobacco Products Because of Impacts from COVID-19

Pharma Reviews: Drug shortages in US market, compliance gains positive for pharma exporters

Concerns over price erosion in the US market, which has impacted the revenue growth of Indian pharma majors over the last four years, could be ...
Read more: Drug shortages in US market, compliance gains positive for pharma exporters

Pharma Reviews: Gilead's antiviral drug remedesivir being made in India on trial basis

A pharma industry source also said, "Gilead is likely to sign compulsory license agreements with Indian majors. The company has done that earlier as ...
Read more: Gilead's antiviral drug remedesivir being made in India on trial basis

Pharma Reviews: Coronavirus vaccine: UK, Germany start trial; Indian pharma will also play a big role

Indian pharmaceutical companies, well-known for producing affordable low-cost medicines, will play an important role in the global fight against the ...
Read more: Coronavirus vaccine: UK, Germany start trial; Indian pharma will also play a big role

Wednesday, April 22, 2020

US FDA News: Coronavirus (COVID-19) Update: Daily Roundup April 22, 2020

Coronavirus (COVID-19) Update: Daily Roundup
Read more: Coronavirus (COVID-19) Update: Daily Roundup April 22, 2020

US FDA News: FDA Approves New Therapy for Triple Negative Breast Cancer That Has Spread, Not Responded to Other Treatments

FDA granted accelerated approval to Trodelvy (sacituzumab govitecan-hziy) for the treatment of adult patients with triple-negative breast cancer that has spread. Patients must have received at least two prior therapies.
Read more: FDA Approves New Therapy for Triple Negative Breast Cancer That Has Spread, Not Responded to Other Treatments

Pharma Reviews: Domestic pharma getting multiples closer to FMCG than US generic pharma: Ravi Dharamshi

A pharma sector market cap of approximately Rs 10 lakh crore in India corrected all the way to less than Rs 3 lakh crore. The weightage in Nifty went ...
Read more: Domestic pharma getting multiples closer to FMCG than US generic pharma: Ravi Dharamshi

Pharma Reviews: OYO cuts fixed pay of all by 25%, asks some India employees to go on leave

"OYO has been a leading brand in the hospitality industry, hence the ... Indian Pharma firms will play an important role in the fight against COVID19 ...
Read more: OYO cuts fixed pay of all by 25%, asks some India employees to go on leave

Pharma Reviews: Kotak Mahindra Bank's board approves proposal to raise about Rs 7500 crore

OYO cuts fixed pay of all by 25%, asks some India employees to go on leave ... This is due to its above-industry-average risk management, earnings and ... Those going on this leave will avail benefits such as continuation of medical ...
Read more: Kotak Mahindra Bank's board approves proposal to raise about Rs 7500 crore

Pharma Reviews: Indian Analytics Industry Will Rebound From Recession Better Than Contemporaries: Latest ...

It suggests that in terms of impact, the overall Indian industry typically will not ... to be 30% for the global BFSI sector, and 10% for the Pharma sector.
Read more: Indian Analytics Industry Will Rebound From Recession Better Than Contemporaries: Latest ...

Pharma Reviews: Indian Pharma firms will play an important role in the fight against COVID19 pandemic ...

"Indian pharmaceutical companies are global leaders in producing affordable low-cost medicines and will play an important role in the fight against ...
Read more: Indian Pharma firms will play an important role in the fight against COVID19 pandemic ...

Pharma Reviews: Indian firms begin developing remdesivir for Covid-19 research, hope to land licensing deal

“Due to this, key pharma companies have started the process to develop the drug's raw material, the active pharmaceutical ingredients (APIs),” an ...
Read more: Indian firms begin developing remdesivir for Covid-19 research, hope to land licensing deal

Pharma Reviews: TREND: Drug cos' Jan-Mar earnings a test for recent rally in stocks

Companies with more reliance on the Indian drug market are expected to benefit more from the current crisis as domestic demand for preventive ...
Read more: TREND: Drug cos' Jan-Mar earnings a test for recent rally in stocks

Pharma Reviews: With new drug policy, India has a golden opportunity to grab on APIs, says doctor KV Surendranath ...

In emergencies when audit and manufacturing approval norms are relaxed it is also on the pharma companies to prove the integrity of their ...
Read more: With new drug policy, India has a golden opportunity to grab on APIs, says doctor KV Surendranath ...

Pharma Reviews: COVID-19 impact: Pharma industry sends fresh SoS to government, says capacity utilisation at 50%

"Given that most of India's active pharmaceutical ingredients (API) and key starting materials (KSM) are imported from China, the supplies were ...
Read more: COVID-19 impact: Pharma industry sends fresh SoS to government, says capacity utilisation at 50%

Tuesday, April 21, 2020

US FDA News: Coronavirus (COVID-19) Update: Daily Roundup April 21, 2020

Coronavirus (COVID-19) Update: Daily Roundup
Read more: Coronavirus (COVID-19) Update: Daily Roundup April 21, 2020

US FDA News: Trividia Health, Inc. Issues Nationwide Voluntary Recall for an Isolated TRUE METRIX AIR Blood Glucose Meter with Serial Number TA1548753

Trividia Health, Inc. today announced it is initiating a nationwide voluntary recall of one (1) TRUE METRIX® AIR Blood Glucose Meter distributed in the United States to one customer (AssuraMed). The meter was not packaged into storebrand or retail branded packaging.
Read more: Trividia Health, Inc. Issues Nationwide Voluntary Recall for an Isolated TRUE METRIX AIR Blood Glucose Meter with Serial Number TA1548753

Pharma Reviews: Messe Frankfurt to Focus on Highlighting Urgent Anti-Counterfeiting Measures in Wake of Covid-19

Together with healthcare workers on the frontline, the pharmaceutical ... for the pharma industry, Messe Frankfurt India will bring key anti-counterfeit ...
Read more: Messe Frankfurt to Focus on Highlighting Urgent Anti-Counterfeiting Measures in Wake of Covid-19

Pharma Reviews: Coronavirus lockdown: In Goa, data sheets, thermal guns ready

Coronavirus (COVID-19): Goa has 3,000 industrial units in 24 estates, ... Goa accounts for 11 per cent of India's Pharma exports with the now iconic ...
Read more: Coronavirus lockdown: In Goa, data sheets, thermal guns ready

Pharma Reviews: Major challenges for India and the LAC region Post COVID-19

Essential good manufacturing industries are those industries who manufacture essential products, like Food Processing, Pharmaceuticals, Health Care, ...
Read more: Major challenges for India and the LAC region Post COVID-19

Pharma Reviews: China moves to buyout iconic Swedish brands like Volvo, Hasselblad in COVID times

It is a time when Indian businesses looking to establish themselves ... He said that many pharma companies are working for a breakthrough with ...
Read more: China moves to buyout iconic Swedish brands like Volvo, Hasselblad in COVID times

Pharma Reviews: Stock market to bottom out only after corona vaccine or cure: Nilesh Shah

He said that many pharma companies are working for a breakthrough with ... Companies are looking to move out of China, India and Vietnam will be ...
Read more: Stock market to bottom out only after corona vaccine or cure: Nilesh Shah

Pharma Reviews: Himachal Pradesh's coronavirus hotspot hits 55 crucial pharmaceutical facilities

CHANDIGARH: India may soon see a shortage of medicines as nearly 55 crucial pharmaceutical facilities that are part of Asia's largest pharmaceutical ...
Read more: Himachal Pradesh's coronavirus hotspot hits 55 crucial pharmaceutical facilities

Pharma Reviews: India's Pharmaceutical industry playing critical role in combating Covid-19

The Indian government has initiated measures to ensure adequate domestic production of raw materials going into pharmaceutical drug ...
Read more: India's Pharmaceutical industry playing critical role in combating Covid-19

Pharma Reviews: The world's pharmacy

Will this be a turning point for our generic drug industry? ... The Indian drug manufacturers as well as the government have vehemently denied her ...
Read more: The world's pharmacy

Pharma Reviews: Mohali's NIPER focusing on cutting-edge Covid-19 research

Established in 1994 on 130 acres in Sector 67, NIPER is an Indian Public Pharmacy Research University and a part of seven schools under the ...
Read more: Mohali's NIPER focusing on cutting-edge Covid-19 research

Pharma Reviews: Indian pharma majors step in to develop, import coronavirus test kits

Sudarshan Jain, the secretary general of the Indian Pharmaceutical Alliance that represents India's top 25 pharma firms, said: “This is not being done ...
Read more: Indian pharma majors step in to develop, import coronavirus test kits

US FDA News: Coronavirus (COVID-19) Update: FDA Authorizes First Test for Patient At-Home Sample Collection

Coronavirus (COVID-19) Update: FDA Authorizes First Test for Patient At-Home Sample Collection
Read more: Coronavirus (COVID-19) Update: FDA Authorizes First Test for Patient At-Home Sample Collection

Monday, April 20, 2020

US FDA News: Coronavirus (COVID-19) Update: Daily Roundup April 20, 2020

Coronavirus (COVID-19) Update: Daily Roundup
Read more: Coronavirus (COVID-19) Update: Daily Roundup April 20, 2020

US FDA News: B. Braun Medical Inc. Issues Voluntary Nationwide Recall of One (1) Lot of Ceftazidime for Injection USP and Dextrose Injection USP (50 mL), Duplex Container Due to Out-of-Specification Results for High Molecular Weight Polymers

Braun Medical Inc. (B. Braun) is voluntarily recalling one (1) lot of 2g Ceftazidime for Injection USP (2g) and Dextrose for Injection USP (50 ml) in Duplex® Container to the hospital/user level.. During stability testing of Batch H8J812, test results were found to exceed the specification limits fo
Read more: B. Braun Medical Inc. Issues Voluntary Nationwide Recall of One (1) Lot of Ceftazidime for Injection USP and Dextrose Injection USP (50 mL), Duplex Container Due to Out-of-Specification Results for High Molecular Weight Polymers

US FDA News: Fresenius Kabi Issues Voluntary Nationwide Recall of 13 Lots of Ketorolac Tromethamine Injection, USP Due to the Presence of Particulate Matter in Reserve Samples

Fresenius Kabi USA, LLC is voluntarily recalling 13 lots of Ketorolac Tromethamine Injection, USP, 30 mg/mL, 1 mL fill in a 2 mL amber vial and Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL fill in a 2 mL amber vial to the user level due to the presence of particulate matter
Read more: Fresenius Kabi Issues Voluntary Nationwide Recall of 13 Lots of Ketorolac Tromethamine Injection, USP Due to the Presence of Particulate Matter in Reserve Samples

US FDA News: Fresenius Kabi Issues Voluntary Nationwide Recall of 13 Lots of Ketorolac Tromethamine Injection, USP Due to the Presence of Particulate Matter in Reserve Samples

Sunday, April 19, 2020

Pharma Reviews: Govt should utilise IFSC platform to support export industry: Officials

... and increased vigilance measures from the USFDA added to uncertainty about growth of Indian pharma exports - particularly to the US, they added.
Read more: Govt should utilise IFSC platform to support export industry: Officials

Pharma Reviews: Pharma funds are shining, should you invest?

“Indian pharma firms source 60%-80% of their raw material from China. With partial normalisation of manufacturing activities, some pharma ...
Read more: Pharma funds are shining, should you invest?

Pharma Reviews: Govt should utilise IFSC platform to support export industry: Officials

Volatility in exchange rate and increased vigilance measures from the USFDA added to uncertainty about growth of Indian pharma exports ...
Read more: Govt should utilise IFSC platform to support export industry: Officials

Pharma Reviews: Grant Infrastructure Status to Bulk Drug Industry : CII Report on API sector

New Delhi: While Indian pharmaceutical industry has rightfully gained the epithet 'pharmacy to the world', it has also become highly import dependant ...
Read more: Grant Infrastructure Status to Bulk Drug Industry : CII Report on API sector

Pharma Reviews: Covid-19 cure: The story of antiviral medicine remdesivir

Then production of the drug would need to ramp up quickly, no small thing as remdesivir requires complex manufacturing techniques. Given the stakes ...
Read more: Covid-19 cure: The story of antiviral medicine remdesivir

Saturday, April 18, 2020

Pharma Reviews: Indian Embassy in Washington Brings Online Kuchipudi Dance Course on Facebook Amid ...

Amid the ongoing coronavirus lockdown in the US, the Indian embassy in ... the Indian Pharmaceutical Market (IPM), Sun Pharma, Torrent Pharma, ...
Read more: Indian Embassy in Washington Brings Online Kuchipudi Dance Course on Facebook Amid ...

US FDA News: Coronavirus (COVID-19) Update: Serological Test Validation and Education Efforts

FDA provides details about its thinking on antibody tests for COVID-19 and the agency’s approach to making accurate and reliable serology tests widely available.
Read more: Coronavirus (COVID-19) Update: Serological Test Validation and Education Efforts

Pharma Reviews: Can coronavirus crisis change Indian science for good?

Gautam Wankhede, cofounder of Mylab — the first Indian company whose ... India's pharma companies dominate the world's generic drug business.
Read more: Can coronavirus crisis change Indian science for good?

Pharma Reviews: Indian-American Congressman Ro Khanna Gets Appointed To Donald Trump's Coronavirus ...

According to a Emkay research report, the changing preference of drugs by people has also had an impact on the Indian pharmaceutical industry with ...
Read more: Indian-American Congressman Ro Khanna Gets Appointed To Donald Trump's Coronavirus ...

Pharma Reviews: Strategic disinvestment of PSUs: Are we missing the big picture?

India can supply medicines to the US, Malaysia and other countries, mainly due to the strategic role given to the public sector in the pharma industry in the 1970-80s. The pandemic raises concerns over the ongoing privatisation ...
Read more: Strategic disinvestment of PSUs: Are we missing the big picture?

Pharma Reviews: India's Pharmaceutical industry playing critical role in combating Covid-19

Apart from lot of challenges, Indian pharma industry along with other companies are overcoming the challenges of supply chain, manufacturing ...
Read more: India's Pharmaceutical industry playing critical role in combating Covid-19

Pharma Reviews: Covid-19 changes medication needs of masses

The brokerage report said that the Indian pharmaceutical market (IPM) growth slowed down to 5.4 per cent yoy in March 2020 as companies with acute- ...
Read more: Covid-19 changes medication needs of masses

Pharma Reviews: Indian IT Industry Rises Strong Against COVID-19 Pandemic

Moreover, the three key players of India's IT industry have come up with a ... clinical data for drug trials for a pharma and biotechnology company.
Read more: Indian IT Industry Rises Strong Against COVID-19 Pandemic

Pharma Reviews: Overcoming all COVID-19 odds, this pharma company delivered life-saving medicine to patients

Hubei, which is also a major hub for pharmaceutical manufacturing, was the worst hit. Back in India, with every passing day, the inventories of ...
Read more: Overcoming all COVID-19 odds, this pharma company delivered life-saving medicine to patients

Pharma Reviews: Conference on 'COVID-19 impact on Trade & Industry' held

Anil Gupta said that Indian Pharma industry has been a world leader in generics both globally and in domestic markets contributing significantly to the ...
Read more: Conference on 'COVID-19 impact on Trade & Industry' held

Pharma Reviews: Challenges post corona world has to face

The impact of Covid-19 on Indian pharma has so far been limited due to ... The health insurance sector could see better days as people would now ...
Read more: Challenges post corona world has to face

Friday, April 17, 2020

US FDA News: Important Information on the Use of Serological (Antibody) Tests for COVID-19 - Letter to Health Care Providers

The FDA recommends that health care providers continue to use serological tests intended to detect antibodies to SARS-CoV-2 to help identify people who may have been exposed to the SARS-CoV-2 virus or have recovered from the COVID-19 infection.
Read more: Important Information on the Use of Serological (Antibody) Tests for COVID-19 - Letter to Health Care Providers

US FDA News: Coronavirus (COVID-19) Update: Daily Roundup April 17, 2020

Coronavirus (COVID-19) Update: Daily Roundup
Read more: Coronavirus (COVID-19) Update: Daily Roundup April 17, 2020

US FDA News: FDA Approves First Targeted Treatment for Patients with Cholangiocarcinoma, a Cancer of Bile Ducts

FDA has approved Pemazyre (pemigatinib), the first treatment approved for adults with certain types of previously treated, advanced cholangiocarcinoma, a rare form of cancer that forms in bile ducts.
Read more: FDA Approves First Targeted Treatment for Patients with Cholangiocarcinoma, a Cancer of Bile Ducts

US FDA News: Coronavirus (COVID-19) Update: Federal judge enters temporary injunction against Genesis II Church of Health and Healing, preventing sale of Chlorine Dioxide Products Equivalent to Industrial Bleach to Treat COVID-19

A federal court has entered an injunction against the Genesis II Church of Health and Healing requiring them to immediately stop distributing its “Miracle Mineral Solution”
Read more: Coronavirus (COVID-19) Update: Federal judge enters temporary injunction against Genesis II Church of Health and Healing, preventing sale of Chlorine Dioxide Products Equivalent to Industrial Bleach to Treat COVID-19

US FDA News: Coronavirus (COVID-19) Update: Federal judge enters emergency injunction against Genesis II Church of Health and Healing, preventing sale of Chlorine Dioxide Products Equivalent to Industrial Bleach to Treat COVID-19

A federal court has entered an emergency temporary restraining order and a preliminary injunction against the Genesis II Church of Health and Healing requiring them to immediately stop distributing its “Miracle Mineral Solution”
Read more: Coronavirus (COVID-19) Update: Federal judge enters emergency injunction against Genesis II Church of Health and Healing, preventing sale of Chlorine Dioxide Products Equivalent to Industrial Bleach to Treat COVID-19

US FDA News: FDA Approves First New Drug Under International Collaboration, A Treatment Option for Patients with HER2-Positive Metastatic Breast Cancer

FDA has approved Tukysa (tucatinib) in combination with chemotherapy for the treatment of adults with advanced forms of HER2-positive breast cancer that can’t be removed with surgery, or has spread to other parts of the body, and who have received one or more prior treatments.
Read more: FDA Approves First New Drug Under International Collaboration, A Treatment Option for Patients with HER2-Positive Metastatic Breast Cancer

Pharma Reviews: Courses and career scope in pharmacy in India

The pharmaceutical market is one of the few sectors that have shown double-digit Compounded Annual Growth Rate (CAGR) in the last few years.
Read more: Courses and career scope in pharmacy in India

Thursday, April 16, 2020

Pharma Reviews: Interview: Gauri Chaudhari on why healthcare brands matter

The Indian healthcare industry, particularly the pharmaceutical industry, chartered a different path than most of its western counterparts. We followed ...
Read more: Interview: Gauri Chaudhari on why healthcare brands matter

Pharma Reviews: Analytics and Data Science India Industry Study 2020 – By AIM & AnalytixLabs

The Pharma sector, which includes the Domestic and MNC captive pharma companies, contributed $ 0.9 Bn in terms of revenues. While this ...
Read more: Analytics and Data Science India Industry Study 2020 – By AIM & AnalytixLabs

Pharma Reviews: TREND:Investors dig into pharma shrs as storing essentials now a norm

MUMBAI – The stellar rally in the shares of Indian pharmaceutical companies could extend in the near term as the COVID-19 pandemic has prompted ...
Read more: TREND:Investors dig into pharma shrs as storing essentials now a norm

Pharma Reviews: PM Modi's Hydroxycholroquine Diplomacy – International Politics, Global Markets and COVID-19

Granules India Ltd. which is also a major manufacturer of pharmaceutical formulations got approval from US Food & Drug Administration (USFDA) of ...
Read more: PM Modi's Hydroxycholroquine Diplomacy – International Politics, Global Markets and COVID-19

Pharma Reviews: Healthcare: Time For A Booster Dose?

A recent report says India will require around 27 million N95 masks, ... According to ICICI Securities, the Indian pharmaceutical industry has seen 12.1 ...
Read more: Healthcare: Time For A Booster Dose?

US FDA News: Coronavirus (COVID-19) Update: FDA, Gates Foundation, UnitedHealth Group, Quantigen, and U.S. Cotton Collaborate to Address Testing Supply Needs

Coronavirus (COVID-19) Update: FDA, Gates Foundation, UnitedHealth Group, Quantigen, and US Cotton collaborate to address testing supply needs
Read more: Coronavirus (COVID-19) Update: FDA, Gates Foundation, UnitedHealth Group, Quantigen, and U.S. Cotton Collaborate to Address Testing Supply Needs

US FDA News: Coronavirus (COVID-19) Update: Daily Roundup April 16, 2020

Coronavirus (COVID-19) Update: Daily Roundup
Read more: Coronavirus (COVID-19) Update: Daily Roundup April 16, 2020

US FDA News: Avet Pharmaceuticals Inc. Issues Voluntary Nationwide Recall of Tetracycline HCl Capsules USP, 250 mg and 500 mg Due to Failed Dissolution Specifications

Avet Pharmaceuticals Inc. (“Avet”), based in East Brunswick, New Jersey, is initiating a voluntary recall of the following lots of Tetracycline HCl Capsules USP, 250 mg and 500 mg, 100-count bottles listed in the table below to the consumer/user level. These drug products are manufactured by Avet Ph
Read more: Avet Pharmaceuticals Inc. Issues Voluntary Nationwide Recall of Tetracycline HCl Capsules USP, 250 mg and 500 mg Due to Failed Dissolution Specifications

US FDA News: Coronavirus (COVID-19) Update: FDA Continues User-Fee Related Reviews Through COVID-19

The FDA is continuing to perform user fee review activities and application reviews
Read more: Coronavirus (COVID-19) Update: FDA Continues User-Fee Related Reviews Through COVID-19

US FDA News: Coronavirus (COVID-19) Update: FDA Encourages Recovered Patients to Donate Plasma for Development of Blood-Related Therapies

FDA is providing an update on one potential COVID-19 treatment called convalescent plasma and encouraging those who have recovered from COVID-19 to donate plasma to help others fight this disease.
Read more: Coronavirus (COVID-19) Update: FDA Encourages Recovered Patients to Donate Plasma for Development of Blood-Related Therapies

Pharma Reviews: India fast-tracks Covid-19 fighting drug supplies to UAE

India is fast-tracking procedures to supply hydroxychloroquine, a drug considered ... Indian pharma industry on Tuesday said there is enough stock of ...
Read more: India fast-tracks Covid-19 fighting drug supplies to UAE

Pharma Reviews: Building on Corona

India's pharmaceutical sector, which supplies 20 per cent medicines and one in every three ... Corona causes world to look at Indian pharma for relief.
Read more: Building on Corona

Pharma Reviews: The Coronavirus Economy

AgVa is getting help from India's largest carmaker Maruti Suzuki India ... At the same time, pharmaceutical companies have ramped up capacities for ...
Read more: The Coronavirus Economy

Pharma Reviews: One Each For Import And Export: How Over-Dependence On China And US Markets Blocks Indian ...

India must ensure that the pharmaceutical sector flourishes. Snapshot. Why the government must work to reduce excessive dependence of Indian ...
Read more: One Each For Import And Export: How Over-Dependence On China And US Markets Blocks Indian ...

Pharma Reviews: Covid-19 lockdown 2.0: telemedicine in India to see continued growth

... of the Covid-19 outbreak in India, the huge rise in e-consultation have been witnessed across companies including second medical opinion platform ...
Read more: Covid-19 lockdown 2.0: telemedicine in India to see continued growth

Pharma Reviews: Azithromycin, paracetamol, other APIs see upto 190% price jump as China resumes production

According to data ThePrint collated from Indian pharma companies, antibiotics azithromycin and ornidazole, anti-inflammatory drug nimesulide and ...
Read more: Azithromycin, paracetamol, other APIs see upto 190% price jump as China resumes production

Pharma Reviews: CNBC-TV18 Market Live: Sensex, Nifty up 1% as pharma, metals rise; Vedanta, Power Grid top ...

Indian indices pared opening losses to turn positive on Thursday led by gains in banking and metal space. The Sensex was trading around 200 points ...
Read more: CNBC-TV18 Market Live: Sensex, Nifty up 1% as pharma, metals rise; Vedanta, Power Grid top ...

Wednesday, April 15, 2020

Pharma Reviews: For this 160-year-old Darjeeling plantation, Trump's push for HCQ is a boon

... additional queries from Indian pharmaceutical and non-pharma companies ... In India, the government has recommended hydroxychloroquine as a ...
Read more: For this 160-year-old Darjeeling plantation, Trump's push for HCQ is a boon

US FDA News: Coronavirus (COVID-19) Update: Daily Roundup April 15, 2020

Coronavirus (COVID-19) Update: Daily Roundup
Read more: Coronavirus (COVID-19) Update: Daily Roundup April 15, 2020

Pharma Reviews: Trump's Malaria Drug Push Is a Boon for 160-Year-Old Plantation

Samuel Rai, director at the Directorate of Cinchona and Other Medicinal Plants, said he received additional queries from Indian pharmaceutical and ...
Read more: Trump's Malaria Drug Push Is a Boon for 160-Year-Old Plantation

US FDA News: Auromedics Pharma LLC Issues Voluntary Nationwide Recall of Product Ampicillin and Sulbactam for Injection USP 1.5 g/ Vial, Due to Presence of Glass Particles in the Vial

AuroMedics Pharma LLC is voluntarily recalling lot AFO l 17001-A, Expiry date Dec 2018, of Ampicillin and Sulbactam for Injection USP, 1.5 g (equivalent to 1 g ampicillin as the sodium salt plus 0.5 g Sulbactam as the sodium salt) in a Single-Dose vial, to the hospital level. The product has been found to contain glass particles.
Read more: Auromedics Pharma LLC Issues Voluntary Nationwide Recall of Product Ampicillin and Sulbactam for Injection USP 1.5 g/ Vial, Due to Presence of Glass Particles in the Vial

US FDA News: International Laboratories, LLC Issues Voluntary Nationwide Recall of One (1) Lot of Clopidogrel Tablets USP, 75 mg Packaged in Bottles of 30 Tablets Due to Mislabeling NDC # 54458-888-16; Lot # 117099A

International Laboratories, LLC is voluntarily recalling Lot# 117099A of Clopidogrel Tablets, USP 75 mg, packaged in bottles of 30 tablets, to the consumer level due to mislabeling. The product is labeled as Clopidogrel tablets USP 75 mg but may contain Clopidogrel 75mg or Simvastatin Tablets USP 10 mg.
Read more: International Laboratories, LLC Issues Voluntary Nationwide Recall of One (1) Lot of Clopidogrel Tablets USP, 75 mg Packaged in Bottles of 30 Tablets Due to Mislabeling NDC # 54458-888-16; Lot # 117099A

US FDA News: Baxter Expands Voluntary Nationwide Recall to Include Second Lot of Nexterone Injection Due to Presence of Particulate Matter

Following the issuance of a voluntary recall dated November 10, 2017 of one lot of NEXTERONE (amiodarone HCl) 150 mg/100 mL Premixed Injection, Baxter International Inc. announced today it is expanding the recall to include a second lot (NC109123) of NEXTERONE due to the potential presence of particulate matter.
Read more: Baxter Expands Voluntary Nationwide Recall to Include Second Lot of Nexterone Injection Due to Presence of Particulate Matter

US FDA News: Pharmedium Services, LLC Expands Voluntary Nationwide Recall of Additional Lots of Compounded Sterile Products Within Expiry Due to Lack of Sterility Assurance

January 10, 2018 Lake Forest, IL PharMEDium Services, LLC (PharMEDium) is voluntarily expanding the recall issued on December 27, 2017 to include the below lots of sterile drug products to the hospital/user level due to a lack of assurance of sterility. Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.
Read more: Pharmedium Services, LLC Expands Voluntary Nationwide Recall of Additional Lots of Compounded Sterile Products Within Expiry Due to Lack of Sterility Assurance

US FDA News: PharMEDium Services, LLC Issues Voluntary Nationwide Recall of Certain Lots of Compounded Sterile Products Due to Lack of Sterility Assurance

December 27, 2017 Lake Forest, IL PharMEDium Services, LLC (PharMEDium) is voluntarily recalling the below lots of drug products to the hospital/user level due to a lack of assurance of sterility. Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening. To date, PharMEDium has not received any reports of complaints related to the products but is issuing this recall out of an abundance of caution following a commitment made during a recent inspection of the company’s facility.
Read more: PharMEDium Services, LLC Issues Voluntary Nationwide Recall of Certain Lots of Compounded Sterile Products Due to Lack of Sterility Assurance

US FDA News: AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Levofloxacin in 5% Dextrose 250mg/50mL Due to Presence of Visible Particulate Matter Tentatively Identified as Mold

FOR IMMEDIATE RELEASE – 01-12-2018 – East Windsor, New Jersey, AuroMedics Pharma LLC is voluntarily recalling one lot of Levofloxacin in 5% Dextrose Injection 250mg/50mL in a Single-Use flexible container NDC 55150-243-46, Lot CLF160003, Expiry date May 2018, to the hospital level. The product has been found to contain visible particulate matter tentatively identified as mold. This problem was discovered as a result of a product complaint in which the contents of one flexible bag was found to contain white particulate matter
Read more: AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Levofloxacin in 5% Dextrose 250mg/50mL Due to Presence of Visible Particulate Matter Tentatively Identified as Mold

US FDA News: Primus Announces a Voluntary Nationwide Recall of All Lots Within Expiry of Prescription Medical Food Limbrel® Due to Rare But Serious and Reversible Adverse Events While Seeking FDA's Cooperation to Restore Access for Patients with Medical Necessity

Primus Pharmaceuticals, Inc. of Scottsdale, Arizona is voluntarily recalling all unexpired lots of Limbrel products to the patient (user/consumer) level at FDA's request. FDA has requested a recall of Limbrel due to rare but serious and reversible side effects associated with Limbrel.
Read more: Primus Announces a Voluntary Nationwide Recall of All Lots Within Expiry of Prescription Medical Food Limbrel® Due to Rare But Serious and Reversible Adverse Events While Seeking FDA's Cooperation to Restore Access for Patients with Medical Necessity

US FDA News: Magno-Humphries Laboratories, Inc., Issues Voluntary Nationwide Recall of Basic Drugs Brand of Senna Laxative Due to Mislabeling

Tigard, OR, Magno-Humphries Laboratories, Inc., is voluntarily recalling one lot of Basic Drugs Brand of Senna Laxative tablets, 8.6mg Sennosides to the consumer level due to a customer complaint that their bottle labeled as Senna Laxative actually contained Basic Drugs Brand of Naproxen Sodium 220mg. Naproxen Sodium 220mg tablet is used as a pain reliever and is a nonsteroidal anti-inflammatory drug (NSAID).
Read more: Magno-Humphries Laboratories, Inc., Issues Voluntary Nationwide Recall of Basic Drugs Brand of Senna Laxative Due to Mislabeling

US FDA News: Kareway Products, Inc. Issues Voluntary Nationwide Recall of Gericare Eye Wash Due to Complaints Received on Potential Product Contamination which Compromises Sterility

Compton, California, Kareway Products, Inc is voluntarily recalling 60,000 lots of Gericare Eye Wash, Sterile Eye Irrigation Solution, 4 fluid ounces to the hospital, retail or consumer level. The product has been found to have potential microbial contamination which compromises sterility.
Read more: Kareway Products, Inc. Issues Voluntary Nationwide Recall of Gericare Eye Wash Due to Complaints Received on Potential Product Contamination which Compromises Sterility

US FDA News: Apace Packaging LLC Issues Voluntary Nationwide Recall of Acyclovir (Lot 19900) Due to Product Mix-up

Apace Packaging LLC is voluntarily recalling one lot of Acyclovir Tablet, USP, 400mg, 50ct Unit Dose, NDC# 50268-061-15, Lot Number 19900, to the Retail level. These products have been recalled due to a product mix-up. A small number of blister cards containing Acyclovir Tablets, 400mg, UD Blister Cards may potentially also include Torsemide, 20mg, Tablets.
Read more: Apace Packaging LLC Issues Voluntary Nationwide Recall of Acyclovir (Lot 19900) Due to Product Mix-up

US FDA News: Hospira Issues a Voluntary Nationwide Recall for Labetalol Hydrochloride Injection, USP, Due to the Potential of Cracked Glass at the Rim Surface of the Vials

Hospira, Inc., a Pfizer company, is voluntarily recalling 3 lots of Labetalol Hydrochloride Injection, USP, 100 mg/20 mL Vial (NDC 0409-2267-20), and one lot of Labetalol Hydrochloride Injection, USP, Novaplus® (NDC 0409-2267-25) to the hospital/institution level. Hospira, Inc. initiated this recall due to the discovery of cracks on the rim surface of vials for these lots, which is covered by the stopper and crimp seal.
Read more: Hospira Issues a Voluntary Nationwide Recall for Labetalol Hydrochloride Injection, USP, Due to the Potential of Cracked Glass at the Rim Surface of the Vials

Pharma Reviews: Opinion | Can covid-19 be Indian pharma's Y2K moment?

It also points to a once in a generation opportunity for Indian drug manufacturers as also the wider healthcare sector to become the dominant global ...
Read more: Opinion | Can covid-19 be Indian pharma's Y2K moment?

Pharma Reviews: India is one of the Biggest Producer of Coronavirus Treating Drug Hydroxychloroquine

Two Indian pharmaceutical companies, Zydus Cadila and Ipca Laboratories have ramped up the production of this drug from 3 metric tons per month to ...
Read more: India is one of the Biggest Producer of Coronavirus Treating Drug Hydroxychloroquine

Pharma Reviews: To continue to provide medicines to patients, says Pharma Industry post govt move

In similar vein, Indian Drug Manufacturers' Association Executive Director Ashok K Madan said: "Pharmaceutical industry and its ancillary industries ...
Read more: To continue to provide medicines to patients, says Pharma Industry post govt move

US FDA News: FDA Approves First Therapy for Treatment of Low-Grade Upper Tract Urothelial Cancer

FDA has approved Jelmyto (mitomycin gel), the first therapy to treat low-grade upper tract urothelial cancer (UTUC). Urothelial cancer is a cancer of the lining of the urinary system.
Read more: FDA Approves First Therapy for Treatment of Low-Grade Upper Tract Urothelial Cancer

Pharma Reviews: COVID-19 Crisis Will Open up Opportunities for India's Pharma Industry that Must Be Seized

India's existing advantages in pharmaceuticals should be leveraged by betting on the growth of the global healthcare industry. ‌. Deepanshu Mohan ...
Read more: COVID-19 Crisis Will Open up Opportunities for India's Pharma Industry that Must Be Seized

Pharma Reviews: India fast-tracks HCQ supplies to UAE, leverages drug to get test kits elsewhere

... of active pharmaceutical ingredients. These commercial supplies will go through six Dubai-based consignees having contracts with Indian pharma ...
Read more: India fast-tracks HCQ supplies to UAE, leverages drug to get test kits elsewhere

Pharma Reviews: Sensex, Nifty retreat from bull zone, close 1% lower

Indian stocks slipped into the red on Wednesday, with the benchmark indices ... Shares of Motherson Sumi Systems Ltd are up 14% after a company ... lead the gains, followed by Nifty Metal and Nifty Pharma, up over 3% each.
Read more: Sensex, Nifty retreat from bull zone, close 1% lower

Delhi: Indian Pharma industry is producing enough stocks of essential medicines particularly HCQ to meet both domestic demands and to meet export ...
Read more: Union Pharma Secretary Holds video conference with Pharma manufacturers and associations ...

Pharma Reviews: Govt must take steps to thwart any attempts of takeover in pharma and insurance sectors: Congress

“We are concerned about the takeover attempts of many Indian pharmaceutical entities which are making critical medicines that are required by the ...
Read more: Govt must take steps to thwart any attempts of takeover in pharma and insurance sectors: Congress

The move comes as the demand for the 'wonder drug' increases amid Coronavirus scare, the Gujarat state board of the Indian Drug Manufacturers' ...
Read more: The three largest drug manufacturers in Gujarat to double production of 'wonder drug ...

Pharma Reviews: COVID-19 pandemic long-term impact on Indian healthcare

Medical devices can be a natural area for expansion of pharma companies, because of synergies of end customers even though new manufacturing ...
Read more: COVID-19 pandemic long-term impact on Indian healthcare