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Results For "cGMP-inspection"

21 News Found

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 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


USFDA classifies Biocon Biologics’ Biocon Park in Bengaluru as VAI
News | November 11, 2024

USFDA classifies Biocon Biologics’ Biocon Park in Bengaluru as VAI

The inspection scope had included six separate Biologics manufacturing units comprising of four Drug Substance and two Drug Product manufacturing plants


Briefs: Sun Pharmaceutical Industries and Biocon Biologics
News | November 04, 2024

Briefs: Sun Pharmaceutical Industries and Biocon Biologics

The US District Court of New Jersey decided to grant a preliminary injunction delaying the launch of LEQSELVI


USFDA completes inspection at Biocon Biologics’ Insulins facility at Malaysia
Drug Approval | September 30, 2024

USFDA completes inspection at Biocon Biologics’ Insulins facility at Malaysia

The inspection concluded with the issuance of a form 483 with five observations


USFDA completes inspection at Biocon Biologics’ facilities in Bengaluru
News | July 29, 2024

USFDA completes inspection at Biocon Biologics’ facilities in Bengaluru

The inspection scope included 6 separate Biologics manufacturing units comprising 4 Drug Substance and 2 Drug Product manufacturing plants


Briefs: Zydus Lifesciences and Divi's Laboratories
Drug Approval | July 22, 2024

Briefs: Zydus Lifesciences and Divi's Laboratories

Zydus receives final approval from USFDA for its NDA Zituvimeta, extended-release tablets


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


Briefs: Neuland Laboratories, Cipla and Zydus
Drug Approval | February 20, 2023

Briefs: Neuland Laboratories, Cipla and Zydus

Cipla has received 8 inspectional observations in Form 483