Tag: FDA
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Zydus Life’s US arm announces FDA nod for paediatric drug CUTX-101 NDA resubmission
Drug firm Zydus Lifesciences Ltd on Monday (December 15) said its wholly-owned US-based subsidiary, Sentynl Therapeutics Inc, announced that the US Food and Drug...
Granules India arm passes US FDA quality check for Hyderabad unit
Granules Life Sciences Private Limited (GLS), a wholly-owned subsidiary of Granules India Limited, has received an Establishment Inspection Report (EIR) from the US Food...
Piramal Pharma gets four observations from US FDA after Lexington facility inspection
Piramal Pharma Ltd on Thursday, December 11, said the US Food and Drug Administration (US FDA) has issued a Form 483 with four observations...
Zydus Lifesciences gets final FDA nod for high BP drug verapamil hydrochloride
Drug maker Zydus Lifesciences Ltd on Tuesday (November 25) said it has received final approval from the United States Food and Drug Administration (FDA)...
Natco Pharma gets seven FDA observations at Manali API unit
Natco Pharma on Friday, November 21, said the US Food and Drug Administration (FDA) has concluded its inspection of the company’s active pharmaceutical ingredient...
