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Results For "GMP"

507 News Found

Biocon posts Q1 FY25 PAT higher at Rs. 660 Cr
News | August 10, 2024

Biocon posts Q1 FY25 PAT higher at Rs. 660 Cr

This strong performance was primarily on account of a one-time gain from the strategic collaboration between Biocon Biologics and Eris Lifesciences.


OneSource and BRL ink technology licensing agreement to deliver high-concentration biologics subcutaneously
News | August 06, 2024

OneSource and BRL ink technology licensing agreement to deliver high-concentration biologics subcutaneously

Revolutionary technology will further boost OneSource’s scientific services offerings


Dr. Reddy's receives positive CHMP opinion from EMA for its proposed Rituximab biosimilar
Drug Approval | July 30, 2024

Dr. Reddy's receives positive CHMP opinion from EMA for its proposed Rituximab biosimilar

Dr. Reddy's had previously received the EU GMP certificate for its Rituximab drug substance


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: Indoco Remedies and Alembic Pharmaceuticals
Drug Approval | July 29, 2024

Briefs: Indoco Remedies and Alembic Pharmaceuticals

Indoco Remedies is addressing the observations comprehensively and will respond to the USFDA within the stipulated timeframe


USFDA inspects Gland Pharma’s Dundigal facility
Drug Approval | July 26, 2024

USFDA inspects Gland Pharma’s Dundigal facility

The inspection was concluded with two 483 observations


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


Merck inks MoU with Afrigen Biologics for development of mRNA vaccine technology platform
News | July 05, 2024

Merck inks MoU with Afrigen Biologics for development of mRNA vaccine technology platform

Aim of the collaboration is to develop mRNA platform technology, scale up and troubleshoot challenges in mRNA process optimization


Urgent need to redefine pharma companies’ role on several issues of the industry: Dr. K. Nagaiah, Chief Scientist, CSIR - IICT, Hyderabad
Opinion | July 04, 2024

Urgent need to redefine pharma companies’ role on several issues of the industry: Dr. K. Nagaiah, Chief Scientist, CSIR - IICT, Hyderabad

The expiry date of almost all strips is rubber stamped vanish in a matter of 3 to 4 months, making the remaining tablets waste for subsequent use before expire date


Jubilant Ingrevia receives EIR from USFDA for Unit-1 at Bharuch
Drug Approval | June 28, 2024

Jubilant Ingrevia receives EIR from USFDA for Unit-1 at Bharuch

This existing GMP compliant facility, located at Bharuch (Unit-1) with ongoing expansion part of the company's strategic capex initiative