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Results For "GMP"

507 News Found

Briefs: Jagsonpal Pharmaceuticals, Dr. Reddy’s Laboratories and Akums Drugs and Pharmaceuticals
News | November 20, 2024

Briefs: Jagsonpal Pharmaceuticals, Dr. Reddy’s Laboratories and Akums Drugs and Pharmaceuticals

Jagsonpal Pharmaceuticals has received full consideration of Rs. 41 crore towards the sale of the facility and will now be proceeding with registration formalities


USFDA classifies Biocon Biologics’ Biocon Park in Bengaluru as VAI
News | November 11, 2024

USFDA classifies Biocon Biologics’ Biocon Park in Bengaluru as VAI

The inspection scope had included six separate Biologics manufacturing units comprising of four Drug Substance and two Drug Product manufacturing plants


Granules India’s Unit V facility secures USFDA EIR with NAI status
Drug Approval | November 10, 2024

Granules India’s Unit V facility secures USFDA EIR with NAI status

The FDA conducted a comprehensive Pre-Approval Inspection (PAI) and cGMP audit


Lonza’s Synaffix collaborates with BigHat Biosciences for ML-designed ADC
News | November 05, 2024

Lonza’s Synaffix collaborates with BigHat Biosciences for ML-designed ADC

Commercial license to Synaffix technologies follows a series of successful initial preclinical proof of concept studies


Briefs: Sun Pharmaceutical Industries and Biocon Biologics
News | November 04, 2024

Briefs: Sun Pharmaceutical Industries and Biocon Biologics

The US District Court of New Jersey decided to grant a preliminary injunction delaying the launch of LEQSELVI


USFDA inspection of Shilpa Medicare Unit VI at Bengaluru
Drug Approval | November 02, 2024

USFDA inspection of Shilpa Medicare Unit VI at Bengaluru

The inspection concluded with the issuance of Form 483 with four observations which are procedural in nature


MilliporeSigma invests US$ 76 million to expand ADC manufacturing in North America
News | November 02, 2024

MilliporeSigma invests US$ 76 million to expand ADC manufacturing in North America

Reinforces position as first commercially approved contract development and manufacturing organization (CDMO) for ADCs in North America


Supriya Lifescience reports 19% revenue increase in Q2 FY25
News | November 01, 2024

Supriya Lifescience reports 19% revenue increase in Q2 FY25

The company reported a net profit of Rs 46.15 crore in Q2 FY25 as compared to Rs 23.88 crore in Q2 FY24


Lonza extends collaboration with global biopharmaceutical partner for commercial-scale manufacture of ADCs
Biotech | October 23, 2024

Lonza extends collaboration with global biopharmaceutical partner for commercial-scale manufacture of ADCs

Extension of long-term collaboration includes construction of new customer-dedicated bioconjugation capacity in Visp (CH) and commercial antibody supply of a new ADC


Shilpa Medicare’s CDMO customer gets fast-track designation for its investigational drug candidate
Drug Approval | October 16, 2024

Shilpa Medicare’s CDMO customer gets fast-track designation for its investigational drug candidate

GBM affects nearly 13,000 patients annually in the US and approximately 300,000 globally