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Results For "PMDA"

36 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


FDA completes inspection of SMS Pharma’s Vizag facility
Drug Approval | December 14, 2025

FDA completes inspection of SMS Pharma’s Vizag facility

The inspection concluded with one minor observation in Form 483


Renalys Pharma reports major phase III success for Sparsentan in Japanese IgA nephropathy patients
Clinical Trials | November 28, 2025

Renalys Pharma reports major phase III success for Sparsentan in Japanese IgA nephropathy patients

The study, which enrolled 35 Japanese patients, evaluated the percent change from baseline in the 24-hour urine protein-to-creatinine ratio


Piramal Pharma Solutions’ UK facility bags updated MHRA GMP certification
News | November 21, 2025

Piramal Pharma Solutions’ UK facility bags updated MHRA GMP certification

Grangemouth serves as PPS’s dedicated antibody-drug conjugate development and manufacturing hub


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