News about Quality / GMP

Dr. Reddy's Biologics Facility in Hyderabad Receives USFDA Form 483 with Five Observations

The USFDA has completed a Pre-Approval Inspection (PAI) at Dr. Reddy's biologics manufacturing facility in Bachupally, Hyderabad, with five observations.

Quality / GMP | 13/09/2025 | By Dineshwori |  322

Cohance's Jaggaiahpet API Plant Clears USFDA Inspection with Zero 483 Observations

The United States Food and Drug Administration (USFDA) has completed a general current Good Manufacturing Practices (cGMP) audit at Cohance Lifesciences' API manufacturing facility (API Unit1) located at Jaggaiahpet, Andhra Pradesh, with zero Form 483 observations.

Quality / GMP | 12/09/2025 | By Dineshwori |  320

Sun Pharma Halol Facility Classified OAI by US FDA, Shipments Restricted

The US Food and Drug Administration (FDA) has classified Sun Pharma's Halol facility as “Official Action Indicated” (OAI) following an inspection conducted between June 2 and June 13, 2025.

Quality / GMP | 10/09/2025 | By Dineshwori |  450

Akums's Hormonal Plant Gets EAEU GMP Nod, Expands into Eurasia

Akums’s Hormonal Plant receives EAEU GMP certification for oral hormonal tablets, enabling entry into Eurasian markets with therapies for women’s health, HRT and endocrine care.

Quality / GMP | 09/09/2025 | By Dineshwori |  179

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 |  740

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 |  368

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 |  208

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 |  317

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 |  206

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 |  453