Last Updated on October 17, 2024 by The Health Master
Drugmaker Granules India Ltd on Monday said the US health regulator has issued “three minor observations” to its wholly-owned arm, Granules Pharmaceuticals, Inc (GPI) in a pre-approval inspection (PAI).
Granules Pharmaceuticals located in Chantilly, Virginia, US, had undergone a PAI by the US Food and Drug Administration (USFDA) from January 24-28, 2022, the company said in a statement.
“The audit is a PAI for two of its product applications filed from this facility.
The USFDA issued three minor observations during the audit conducted at the facility,” it added, without elaborating on the nature of the observations.
Commenting on the audit, GPI Executive Director Priyanka Chigurupati said, “We are glad to have completed yet another audit with minor observations that we will respond to within the stipulated time period”.
USFDA completes audit at MSN Pharma with zero observations
USFDA issues 6 observations to Biocon’s Malaysian facility
Amaris Clinicals completes USFDA Audit with NIL observations: Chennai
Lupin gets these 7 observations from USFDA for Goa Plant
USFDA inspection ends with ‘Zero’ observations: Alkem
Alkem gets two observations from USFDA for USA plant
NPPA seeks clarification on license status of clotrimazole 1% mouth paint
China to strengthen anti-monopoly efforts in Pharma industry
USFDA gives nod to Granules Pharma for potassium chloride for oral solution
Govt Job: For M.Pharm, M.Sc at CDSCO – Central Government | Pay upto Rs. 92,300 pm
Covishield & Covaxin: Why not available at Medical Stores ?
ICMR approves Covid test kit to test all variants
Dr Reddy’s seeks DCGI nod for Sputnik Light as booster dose
Govt starts anti-dumping probe against Ursodiol, a chemical used in Pharma Industry
Latest Notifications regarding Pharmaceuticals
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
