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Results For "GMP-inspection"

59 News Found

Strides completes EU GMP inspection at Puducherry facility
News | June 29, 2021

Strides completes EU GMP inspection at Puducherry facility

The company has now received the renewed GMP (Good Manufacturing Practices) certificate thereby confirming the successful closure of the inspection


Shilpa Medicare receives EIR from USFDA for Unit VI, Bengaluru
Drug Approval | July 17, 2025

Shilpa Medicare receives EIR from USFDA for Unit VI, Bengaluru

This facility is capable of manufacturing, packaging, testing, storage and distribution of two types of complex dosage forms


Shilpa Medicare Unit VI facility at Dabaspet receives GMP certification from SFDA
Drug Approval | July 11, 2025

Shilpa Medicare Unit VI facility at Dabaspet receives GMP certification from SFDA

This was a full GMP inspection of the entire facility with specific focus on Ondansetron Oral Film drug product


Shilpa Pharma Lifesciences Unit-1 inspected by ANVISA
Drug Approval | July 06, 2025

Shilpa Pharma Lifesciences Unit-1 inspected by ANVISA

The audit has been concluded with no major observations


Briefs: Dr. Reddy's Laboratories, Relonchem,  Shilpa Pharma Lifesciences and Shanmuga Hospital
News | May 18, 2025

Briefs: Dr. Reddy's Laboratories, Relonchem, Shilpa Pharma Lifesciences and Shanmuga Hospital

Shilpa Pharma Lifesciences, Unit-1, received EIR from USFDA


Briefs: Alembic Pharmaceuticals and Shelter Pharma
News | March 24, 2025

Briefs: Alembic Pharmaceuticals and Shelter Pharma

Alembic Pharmaceuticals successfully completes USFDA inspection for API-III facility


Briefs: Syngene International and Cipla
Drug Approval | February 23, 2025

Briefs: Syngene International and Cipla

Cipla Limited has received final approval from the USFDA for the New Drug Application submitted for ‘Nilotinib Capsules 50, 150 and 200 mg’


Granules India acquires Swiss Senn Chemicals to foray into peptide and CDMO business
News | February 22, 2025

Granules India acquires Swiss Senn Chemicals to foray into peptide and CDMO business

The acquisition aligns with Granules' vision to enter the rapidly expanding peptide-based anti-diabetic and anti-obesity market


USFDA issues Form-483 for Piramal Pharma's facility at Turbhe
Drug Approval | February 21, 2025

USFDA issues Form-483 for Piramal Pharma's facility at Turbhe

Observations are largely around improvement of procedures and practices


USFDA classifies Biocon Biologics Johor Bahru site, Malaysia as VAI
Drug Approval | January 13, 2025

USFDA classifies Biocon Biologics Johor Bahru site, Malaysia as VAI

Biocon Biologics remains committed to global standards of quality and compliance