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1627 News Found

Zydus receives EIR for injectables manufacturing facility at Zydus Biotech Park, Ahmedabad
News | September 14, 2023

Zydus receives EIR for injectables manufacturing facility at Zydus Biotech Park, Ahmedabad

The inspection was a cGMP Inspection and had ended with NIL observations


Biocon acquires oral solid dosage manufacturing facility of Eywa Pharma for US$7.7 million
News | September 02, 2023

Biocon acquires oral solid dosage manufacturing facility of Eywa Pharma for US$7.7 million

The facility has a potential for capacity expansion up to 2 billion tablets/capsules per year


USFDA delegation visits Amneal Pharmaceutical facility in Matoda
News | September 02, 2023

USFDA delegation visits Amneal Pharmaceutical facility in Matoda

Amneal’s site in Matoda is one of the company’s 12 pharmaceutical manufacturing facilities


Gland Pharma receives 2 observations under 483 for Pashamylaram facility
News | August 28, 2023

Gland Pharma receives 2 observations under 483 for Pashamylaram facility

The company is committed to address the observations and will submit its response to US FDA within the stipulated time


Lupin's Mandideep Unit-2 facility completes USFDA inspection with no observations
Drug Approval | August 16, 2023

Lupin's Mandideep Unit-2 facility completes USFDA inspection with no observations

The inspection was conducted from August 7 to August 11, 2023 and concluded without any observations.


USFDA completes PAD E inspection of Marksans' Goa facility
Drug Approval | August 09, 2023

USFDA completes PAD E inspection of Marksans' Goa facility

The inspection was conducted at its Goa, Vema manufacturing facility


USFDA completes two cGMP inspections at Biocon Biologics' insulins facility in Malaysia
Drug Approval | July 24, 2023

USFDA completes two cGMP inspections at Biocon Biologics' insulins facility in Malaysia

The agency issued a Form 483 with 6 observations for Drug Substance, Drug Product units and Quality Control laboratories


Strand Life Sciences expands sequencing facility
Medical Device | July 19, 2023

Strand Life Sciences expands sequencing facility

The newly launched Genomic Health Insights (GHI) program to make sequencing accessible to all


Syngene to acquire multi-modal facility from Stelis Biopharma
News | July 05, 2023

Syngene to acquire multi-modal facility from Stelis Biopharma

Adding 20,000 liters of installed biologics drug substance manufacturing capacity