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Results For "PMDA"

32 News Found

Shilpa Pharma Lifesciences’ Unit II, Raichur, Karnataka clears PMDA Japan, GMP inspection
Drug Approval | September 02, 2023

Shilpa Pharma Lifesciences’ Unit II, Raichur, Karnataka clears PMDA Japan, GMP inspection

The inspection has concluded successfully on 1st September 2023 without any critical/major observation


Sai Life Sciences receive Certificate of Inspection from Japan PMDA
Biotech | December 02, 2021

Sai Life Sciences receive Certificate of Inspection from Japan PMDA

The company has also started working with a large pharma company on the API supply of a recently launched animal and human health product


Sai Life Sciences completes Phase II of production block 11 at Bidar
News | August 29, 2025

Sai Life Sciences completes Phase II of production block 11 at Bidar

With the addition of Phase II (~91 KL) in Q1 FY26, the combined capacity of the block now stands at ~200 KL


Hikal reports Q1 FY26 consolidated loss of Rs. 22.4 Cr
News | August 08, 2025

Hikal reports Q1 FY26 consolidated loss of Rs. 22.4 Cr

Hikal has reported total income of Rs. 381.4 crores during the period ended June 30, 2025


Briefs: Ami Organics and Panacea Biotec
News | April 25, 2025

Briefs: Ami Organics and Panacea Biotec

Ami Organics’ Ankleshwar Unit II gets GMP compliant by PMDA Japan


SMS Pharmaceuticals completes USFDA inspection at Hyderabad facility
Drug Approval | March 22, 2025

SMS Pharmaceuticals completes USFDA inspection at Hyderabad facility

The inspection, conducted from March 17 to March 21, 2025, concluded with one observation in Form 483


Glenmark Life Sciences rebranded as Alivus Life Sciences
News | January 19, 2025

Glenmark Life Sciences rebranded as Alivus Life Sciences

The change is reflective of the company’s evolving vision aimed at further strengthening its global presence and a commitment to providing innovative solutions in the API and CDMO space


Japan Health Authority approves Biocon Biologics’ Ustekinumab BS, Biosimilar to J&J's Stelara
News | January 07, 2025

Japan Health Authority approves Biocon Biologics’ Ustekinumab BS, Biosimilar to J&J's Stelara

The biosimilar Ustekinumab has been developed and manufactured by the company


Briefs: Ami Organics and Dr. Reddy’s Laboratories
Drug Approval | September 09, 2024

Briefs: Ami Organics and Dr. Reddy’s Laboratories

Ami informs that PMDA Japan has issued Inspection Result Report declaring the Sachin facility as a Good Manufacturing Practices (GMP) compliant.


Ami Organics reports Q1FY25 PAT lower 34% at Rs. 14.7 Cr
News | August 12, 2024

Ami Organics reports Q1FY25 PAT lower 34% at Rs. 14.7 Cr

Q1FY25 Revenue from Operations grew by 15% to Rs. 177 crore