USFDA inspects Piramal Pharma Lexington facility

The company is preparing a detailed response to the observations, which will be submitted to the USFDA within the stipulated timelines.

CDSCO and State Drugs Control Administration commence joint inspection of drug manufacturing units

A committee of two Joint Drugs Controllers has been constituted at CDSCO to monitor the process of inspection, reporting, and subsequent action to ensure compliance to the Drugs & Cosmetics Act, 1940

Biocon Biologics insulins facility in Malaysia receives EU GMP Certification

The company has received the Certificate of GMP Compliance from the representative European inspection authority, Health Products Regulatory Authority (HPRA), Ireland.

PIB: Quality control of Ayush drugs

Sun gets 10 observations from USFDA for Halol facility

The company is preparing the response to the observations, which will be submitted to the USFDA within 15 business days

GMP certification for Exothera further extends its viral vector manufacturing capacity

The expansion makes Exothera one of the largest viral vector facilities in Europe

Intravacc publishes a GMP process for a semi-synthetic Shigella glycoconjugate vaccine

Data published in the prestigious journal ACS Central Science of the American Chemical Society

Prestige BioPharma’s Tuznue receives EU-GMP certification

CARsgen Therapeutics opens new U.S. cGMP facility for CAR T production

The RTP manufacturing facility will support the company's clinical studies and early commercial launch in North America and Europe

Prestige BioPharma’s facility receives EU-GMP certification

The facility will manufacture its Herceptin biosimilar, Tuznue