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Results For "inspection"

465 News Found

Lupin receives two observations from USFDA for Ankleshwar facility
Drug Approval | March 09, 2026

Lupin receives two observations from USFDA for Ankleshwar facility

The company will address the observations and respond to the U.S. FDA within the stipulated timeframe


Lupin receives EIR from FDA for its Goa facility
Drug Approval | February 28, 2026

Lupin receives EIR from FDA for its Goa facility

The EIR was issued following an inspection of the facility from November 10 to November 21, 2025


USFDA issues Form 483 with 6 observations to Enzene Biosciences’ Chakan plant following PAI
Drug Approval | February 17, 2026

USFDA issues Form 483 with 6 observations to Enzene Biosciences’ Chakan plant following PAI

The Pre-Approval Inspection (PAI) was completed on February 13, 2026, and the company is initiating corrective actions.


Aarti Drugs reports strong Q3 FY26 performance, PAT surges 58% YoY
News | February 06, 2026

Aarti Drugs reports strong Q3 FY26 performance, PAT surges 58% YoY

On segmental performance, API revenues were largely stable at Rs. 454.3 crore for Q3 FY26, down 1% YoY


Strides Pharma Inc receives USFDA closure report for Chestnut Ridge formulations facility
Drug Approval | February 05, 2026

Strides Pharma Inc receives USFDA closure report for Chestnut Ridge formulations facility

Inspection included drug device combinations covering our recent filing in nasal sprays domain


FDA launches PreCheck program to bring drug manufacturing back to US
News | February 04, 2026

FDA launches PreCheck program to bring drug manufacturing back to US

The program seeks to boost regulatory predictability, support construction of US-based manufacturing sites


Akums bags key EU GMP certifications for 2 Haridwar plants
News | January 24, 2026

Akums bags key EU GMP certifications for 2 Haridwar plants

Plant 1 continues to serve as a core manufacturing hub for oral solid dosage forms


Camurus’ Oclaiz NDA resubmission accepted by FDA
Drug Approval | January 14, 2026

Camurus’ Oclaiz NDA resubmission accepted by FDA

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 10, 2026


Reimagining India’s Pharmaceutical Sector: From Global Supplier to Innovation Leader
Opinion | January 07, 2026

Reimagining India’s Pharmaceutical Sector: From Global Supplier to Innovation Leader

India should explore Sustainability-Linked Incentives (SLI) targeting innovations in the 12 principles of green chemistry