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Results For "Good-Manufacturing-Practice"

144 News Found

Marksans Pharma's Goa unit clears FDA inspection
News | November 10, 2025

Marksans Pharma's Goa unit clears FDA inspection

The said inspection concluded with Zero Form 483 observation


FDA issues warning letter to Philips over manufacturing and quality system deficiencies
Medical Device | October 31, 2025

FDA issues warning letter to Philips over manufacturing and quality system deficiencies

The FDA’s review also revealed delays in Philips’ internal investigations, with 54 inquiries failing to meet targeted completion dates—23 of which were delayed by more than 100 days


Biocon gets 1 USFDA observation for Cranbury site
Drug Approval | October 14, 2025

Biocon gets 1 USFDA observation for Cranbury site

The Cranbury facility represents a strategic advancement of the company's operations in the Unted States


PromoCell launches custom GMP cell culture media to power next-gen cell and gene therapies
Biotech | October 07, 2025

PromoCell launches custom GMP cell culture media to power next-gen cell and gene therapies

New offering to debut at the 32nd ESGCT Congress, October 7–10, 2025, in Seville, Spain


Health Secretary Srivastava chairs meeting with states/UTs on quality and rational use of cough syrups
Policy | October 06, 2025

Health Secretary Srivastava chairs meeting with states/UTs on quality and rational use of cough syrups

States exhorted to ensure rational use of cough syrups, particularly among children, as most coughs are self-limiting and do not require pharmacological treatment


Supriya Lifescience’s Ambernath facility receives WHO GMP certification
News | October 04, 2025

Supriya Lifescience’s Ambernath facility receives WHO GMP certification

With global certification in place, the Ambernath site expands Supriya’s footprint beyond APIs into high-margin formulations


DMMA warns regulatory burden threatening Gujarat’s pharma MSMEs
Policy | September 26, 2025

DMMA warns regulatory burden threatening Gujarat’s pharma MSMEs

The association called for an end to the constant issuance of regulatory circulars that make operations unpredictable and capital-intensive.


Zydus receives EIR for oncology injectable manufacturing facility in Ahmedabad SEZ1
Drug Approval | September 24, 2025

Zydus receives EIR for oncology injectable manufacturing facility in Ahmedabad SEZ1

The facility has been classified as Voluntary Action Indicated


ProBioGen to spearhead GMP manufacturing at Berlin’s gene & cell therapy hub
News | September 17, 2025

ProBioGen to spearhead GMP manufacturing at Berlin’s gene & cell therapy hub

ProBioGen will oversee the design, construction, and operation of the 4,600-square-meter GMP manufacturing unit


Sirio secures TGA GMP certification to support strategic growth in Australia
News | September 10, 2025

Sirio secures TGA GMP certification to support strategic growth in Australia

The Ma’anshan site approval covers pastilles, oral liquids, and powders