News about "good manufacturing practice (GMP)"

USFDA Concludes Inspection at Dr. Reddy's Srikakulam Facility with VAI Classification

USFDA Concludes Inspection at Dr. Reddy's Srikakulam Facility with VAI Classification

Dr. Reddy’s Laboratories has announced that the United States Food and Drug Administration (USFDA) has completed a Good Manufacturing Practice (GMP) and Pre-Approval Inspection (PAI) at its formulations manufacturing facility (FTO 11) in Srikakulam, Andhra Pradesh.

Good Manufacturing Practice (GMP) | 21/10/2025 | By Dineshwori 138

Biocon's Cranbury Facility in US Passes FDA Inspection, Supports Expansion Plans

Biocon's Cranbury Facility in US Passes FDA Inspection, Supports Expansion Plans

Biocon’s inspection concluded with a single observation, which the company will address within the stipulated timeframe, and it is not expected to impact ongoing business operations

Good Manufacturing Practice (GMP) | 15/10/2025 | By Dineshwori

Promocell Enters GMP Field with Launch of Custom Cell Culture Media Services

Promocell Enters GMP Field with Launch of Custom Cell Culture Media Services

PromoCell GmbH has announced its entry into the Good Manufacturing Practice (GMP) field with the launch of custom cell culture media services designed specifically for cell-based therapy and regenerative medicine.

Good Manufacturing Practice (GMP) | 01/10/2025 | By Dineshwori 121

Akums' Haridwar Sterile Facility Receives GMP Certificate from Brazil's ANVISA

Akums' Haridwar Sterile Facility Receives GMP Certificate from Brazil's ANVISA

Akums Drugs and Pharmaceuticals has announced that its sterile manufacturing plant in Haridwar, Uttarakhand, has been awarded the Good Manufacturing Practice (GMP) certificate from ANVISA, the Brazilian health regulatory agency.

Good Manufacturing Practice (GMP) | 28/07/2025 | By Dineshwori 420

Dr. Reddy's Srikakulam Facility Gets Form 483 After USFDA Inspection

Dr. Reddy's Srikakulam Facility Gets Form 483 After USFDA Inspection

Dr. Reddy’s Laboratories has received a Form 483 with seven observations from the United States Food and Drug Administration (USFDA) following an inspection at its formulations manufacturing facility in Srikakulam, Andhra Pradesh.

Good Manufacturing Practice (GMP) | 19/07/2025 | By Dineshwori 341


 

 

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