Biocon gets three observations from US health regulator for Malaysia facility
The FDA has set a target action date for its insulin glargine application in June 2020
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Browsing Tag
United States Food and Drug Administration
USFDA issues Form 483 with five observations to Biocon’s Bengaluru facility
Form 483 is issued to a firm's management at the conclusion of an inspection when investigator has observed any conditions that in…
Strides receives USFDA tentative approval for Triamcinolone Acetonide ointment
Product approval from flagship facility in Bengaluru; to be marketed by Strides Pharma Inc. effective May 30,2020
Alembic Pharma gets final USFDA nod for hypertension drug
Bosentan tablets is the drug used for treatment of pulmonary arterial hypertension
Strides Pharma arm gets tentative USFDA nod for skin ointment
The product will be manufactured at the company's oral dosage facility at Bengaluru and will be marketed by Strides Pharma Inc in…
USFDA approves first treatment for thyroid eye disease
The approval represents the first drug approved for the treatment of thyroid eye disease
USFDA inspects Alembic Pharma’s facility in Karkhadi
The US health regulator issued a form 483 with two observations
Lupin’s partner Concord gets US FDA nod to market Myfortic tablet
The tablets are indicated for prophylaxis of organ rejection in adult patients receiving kidney transplants Lupin said its…
Dr Reddy’s gets four observations from USFDA for Srikakulam plant
The audit of the company's API Srikakulam Plant (SEZ) was completed last week
Torrent Pharma gets warning letter from US FDA for Gujarat facility
The company is committed in maintaining the highest standards of compliances and quality manufacturing across all its facilities…