News about Quality / GMP

Lupin's Aurangabad Facility Gets Two Observations After US FDA Inspection

The United States Food and Drug Administration (US FDA) has completed a product-specific pre-approval inspection at Lupin’s Chhatrapati Sambhajinagar (Aurangabad) manufacturing facility, issuing two observations.

Quality / GMP | 06/09/2025 | By Dineshwori

US FDA Completes Inspection at Aurobindo Pharma's Telangana Unit

The inspection of Aurobindo Pharma’s Apitoria Unit-I facility, conducted from 21-29 August, 2025, concluded with five observations.

Quality / GMP | 30/08/2025 | By Dineshwori |  195

Veranova's Devens Site Clears FDA Inspection with Zero Observations

Veranova's Devens site has successfully completed a routine current Good Manufacturing Practice (cGMP) surveillance inspection by the Food and Drug Administration (FDA).

Quality / GMP | 14/08/2025 | By Dineshwori |  110

No Physical Applications For WHO-GMP (COPP) Approvals After August 15: CDSCO

The Drugs Controller General of India has directed all zonal and sub-zonal offices of the Central Drugs Standard Control Organization (CDSCO) to stop accepting physical applications for WHO-GMP (Certificate of Pharmaceutical Product – COPP) after August 15, 2025.

Quality / GMP | 08/08/2025 | By Dineshwori |  166

Cipla's Bommasandra Facility Gets VAI Classification from USFDA

Cipla has announced that its manufacturing facility in Bommasandra, Bengaluru, has received a Voluntary Action Indicated (VAI) classification from the USFDA following a recent inspection.

Quality / GMP | 06/08/2025 | By Dineshwori |  127

Torrent Pharma's Vizag API Unit Passes USFDA Inspection with Zero Observation

The US Food and Drug Administration (USFDA) has completed the inspection of Torrent Pharma's API manufacturing facility located in Vizag, Andhra Pradesh.

Quality / GMP | 04/08/2025 | By Dineshwori |  180

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.

Quality / GMP | 28/07/2025 | By Dineshwori |  261

186 Drug Samples Declared Substandard in May, 49 from Himachal Pradesh: Govt

A total of 186 drug samples were found to be ‘not of standard quality’ (NSQ) in May 2025, with 49 of them manufactured in Himachal Pradesh, Minister of State for Health and Family Welfare Anupriya Patel informed the Rajya Sabha on Tuesday in a written reply.

Quality / GMP | 23/07/2025 | By Dineshwori |  135

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.

Quality / GMP | 19/07/2025 | By Dineshwori |  218

Asahi Kasei's Microza Division Earns Gold EcoVadis Rating for Sustainability Excellence

The Gold rating reflects the division’s exceptional performance, particularly in the Environment category, highlighting its continued efforts to reduce ecological impact across manufacturing, supply chains, and value-added operations at the Microza Fuji Plant.

Quality / GMP | 17/07/2025 | By Darshana