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127 News Found

FDA issues five observations to Jubilant Pharmova’s Salisbury facility in USA
Drug Approval | January 17, 2025

FDA issues five observations to Jubilant Pharmova’s Salisbury facility in USA

Jubilant Cadista will submit an appropriate action plan to the USFDA on these observations


Shilpa Medicare’s Unit VII, Nacharam, Hyderabad receives GMP certificate from EMA, Austria
News | December 22, 2024

Shilpa Medicare’s Unit VII, Nacharam, Hyderabad receives GMP certificate from EMA, Austria

The company has received the GMP Certification after successful closure of the inspection


Briefs: Alembic Pharmaceuticals and Veerhealth Care
Drug Approval | December 12, 2024

Briefs: Alembic Pharmaceuticals and Veerhealth Care

The successful completion of RRA assessment by the USFDA, would enable company to open up its business in the USA market


Granules India update on USFDA inspection at Gagillapur facility
News | December 05, 2024

Granules India update on USFDA inspection at Gagillapur facility

Granules has undertaken a proactive, voluntary and comprehensive remediation plan to address the six form 483 observations raised by the USFDA


Merck recommends rejection of TRC Capital’s “Mini-Tender” Offer
News | November 23, 2024

Merck recommends rejection of TRC Capital’s “Mini-Tender” Offer

The offer price is approximately 4.32% below the closing price of the Merck common stock on November 11, 2024


Zydus receives EIR for the transdermal manufacturing facility
Drug Approval | October 02, 2024

Zydus receives EIR for the transdermal manufacturing facility

This facility underwent an inspection from 15th to 19th July 2024 and has been classified as Voluntary Action Indicated


Briefs: Lupin, Alembic Pharmaceuticals and Piramal Pharma
Drug Approval | September 29, 2024

Briefs: Lupin, Alembic Pharmaceuticals and Piramal Pharma

Lupin's Pithampur Unit-1 gets Form 483 from USFDA with 3 observations


Panacea Biotec and Sanofi reached settlement agreement for Shan6
News | September 17, 2024

Panacea Biotec and Sanofi reached settlement agreement for Shan6

Sanofi would not manufacture or market any product which infringes the amended claims of Panacea patent, IN272351


Piramal Pharma's GHG Commitment Validated and Approved by SBTi
Sustainability | September 17, 2024

Piramal Pharma's GHG Commitment Validated and Approved by SBTi

This validation aligns with Piramal Pharma's core purpose of 'Doing Well and Doing Good,'


Piramal Pharma Q1 FY25 net loss narrows
News | July 26, 2024

Piramal Pharma Q1 FY25 net loss narrows

EBITDA grew by 31% YoY with EBITDA margin of 11%, a YoY improvement of over 170bps vs. Q1FY24