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1152 News Found

Alembic receives USFDA approval for clarithromycin tablets
Drug Approval | February 01, 2022

Alembic receives USFDA approval for clarithromycin tablets

Clarithromycin tablets USP, 250 mg and 500 mg have an estimated market size of US $ 11 million for twelve months ending September 2021 according to IQVIA


Glenmark receives ANDA approval for hydrochlorothiazide tablets
Drug Approval | January 27, 2022

Glenmark receives ANDA approval for hydrochlorothiazide tablets

According to IQVIA sales data for the 12-month period ending November 2021, the Ziac tablets, 2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg/6.25 mg market achieved annual sales of approximately US $ 30.3 million


Minimizing API losses critical to responsible pharma manufacturing
News | January 27, 2022

Minimizing API losses critical to responsible pharma manufacturing

Antibiotics mixed in wastewater often get disposed of into the water bodies resulting in wider antimicrobial resistance cases


USFDA rejects Merck’s gefapixant; gain approval in Japan
News | January 25, 2022

USFDA rejects Merck’s gefapixant; gain approval in Japan

Merck is studying the Complete Response Letter and it is not related to the safety of gefapixant


Pfizer and OPKO update on the Biologics License Application for Somatrogon
Biotech | January 22, 2022

Pfizer and OPKO update on the Biologics License Application for Somatrogon

Pfizer is evaluating the FDA’s comments and will work with the agency to determine an appropriate path forward


US FDA approves Idorsia’s insomnia drug
Drug Approval | January 21, 2022

US FDA approves Idorsia’s insomnia drug

Quviviq is a dual orexin receptor antagonist, which blocks the binding of the wake-promoting neuropeptides orexins and is thought to turn down overactive wakefulness, as opposed to treatments that generally sedate the brain


Zydus receives final approval from USFDA for Vigabatrin tablets
Drug Approval | January 20, 2022

Zydus receives final approval from USFDA for Vigabatrin tablets

Vigabatrin is an anticonvulsant. It is known to work by stopping the breakdown of a natural calming substance (GABA) in the brain


Natco Pharma signs agreement with Medicines Patent Pool
News | January 20, 2022

Natco Pharma signs agreement with Medicines Patent Pool

This agreement allows Natco to expand access to Covid-19 medicines in 105 countries in generic name


Strides Pharma and subsidiary Universal Corporation enters tie-up with Medicines Patent Pool
News | January 20, 2022

Strides Pharma and subsidiary Universal Corporation enters tie-up with Medicines Patent Pool

They will commercialize molnupiravir in the international markets


DCGI approves Phase 3 clinical trial of Stempeucel to treat Covid-19 patients
Biotech | January 18, 2022

DCGI approves Phase 3 clinical trial of Stempeucel to treat Covid-19 patients

The drug is aimed at treating Covid-19 patients with Acute Respiratory Distress Syndrome (ARDS)