Biocon Biologics gets EIR from US FDA for two manufacturing facilities
The formal closure of the US FDA inspection is expected to enable filing of marketing authorisation applications for the company's…
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Browsing Tag
USFDA
Zydus receives tentative nod from USFDA for Empagliflozin Tablets
The medication is used to improve blood sugar control in adults with Type 2 diabetes mellitus, along with diet and exercise
Alembic Pharma receives four observations from USFDA for Panelav facility
"The US Food and Drug Administration (USFDA) had conducted an inspection at Alembic Pharmaceuticals general oral solid formulation…
FDA launches interactive, PDF-based template to promote greater efficiency and consistency in…
The FDA will select up to nine participants who provide a holistic representation of the medical device industry and meet the…
CDSCO and USFDA sign MoU
The two hailed a bilateral Memorandum of Understanding (MoU) that seeks to promote access to high-quality, safe, effective and…
USFDA issues warning letter to Cipla for Goa manufacturing facility
The company said that it remains committed to maintain highest standards of compliance and will work closely with the agency to…
USFDA completes inspection of Unichem Lab’s Roha facility with no observation
The US health regulator conducted inspection at the company's active pharmaceutical ingredients (APls) manufacturing unit at Roha…
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
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