Tag: USFDA
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Alembic Pharma’s Karakhadi API facility in Gujarat gets an EIR from the USFDA
Drugmaker Alembic Pharma Ltd. announced on Wednesday, June 18, that the United States Food and Drug Administration (USFDA) has issued an Establishment Inspection Report...
Lupin gets tentative USFDA approval for Amifampridine tablets
Global pharmaceutical giant Lupin Ltd. on Monday announced a significant milestone in its expansion strategy within the US market, securing tentative approval from the...
Zydus Life receives final approval from USFDA for Eluxadoline Tablets
Zydus Lifesciences has received final approval from the US Food and Drug Administration (USFDA) to manufacture Eluxadoline Tablets, 75 mg and 100 mg.Eluxadoline is...
Shilpa Medicare’s Raichur unit clears 2nd consecutive USFDA inspection with no observations
Pharmaceutical company Shilpa Medicare Ltd on Friday (March 14) said its wholly owned subsidiary Shilpa Pharma Lifesciences Ltd has successfully cleared a US Food...
JB Chemicals’ Panoli API facility in Gujarat clears USFDA inspection with no observations
JB Chemicals & Pharmaceuticals Ltd on Friday (March 14) announced that its API (Active Pharmaceutical Ingredient) manufacturing facility (D9) in Panoli, Gujarat, successfully cleared...
