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Results For "inspection"

484 News Found

Briefs: Eugia Pharma Specialities and Eugia SEZ
News | March 01, 2024

Briefs: Eugia Pharma Specialities and Eugia SEZ

Eugia Pharma Specialities restarts production at terminally sterilized product lines


Concord Biotech receives GMP certificate from Kenya regulator
Drug Approval | February 26, 2024

Concord Biotech receives GMP certificate from Kenya regulator

The said Unit complies with the prescribed Good Manufacturing practices as per relevant WHO technical Report Series


Piramal Pharma gets Form 483 with 2 observations from USFDA for Lexington, USA facility
Drug Approval | February 26, 2024

Piramal Pharma gets Form 483 with 2 observations from USFDA for Lexington, USA facility

The observations do not pose any risk to site's compliance standards or its business continuity


Briefs: Suven Pharmaceuticals, Remedium Lifecare and Kilitch Drugs India
News | February 24, 2024

Briefs: Suven Pharmaceuticals, Remedium Lifecare and Kilitch Drugs India

Suven Pharmaceuticals’ API and forumulations facilities complete USFDA inspection successfully


Briefs: IOL Chemicals and Pharmaceuticals and Auro Peptides
News | February 20, 2024

Briefs: IOL Chemicals and Pharmaceuticals and Auro Peptides

IOL Chemicals and Pharmaceuticals’ product approved by CDE of NMPA, China


Shilpa Medicare directed to to pay damage to Celltrion
News | January 25, 2024

Shilpa Medicare directed to to pay damage to Celltrion

The matter of Arbitration between Shilpa Medicare Limited and Celltrion towards supply and distribution agreement


Indoco Remedies receives EIR from USFDA for Goa Plant-I
Drug Approval | January 18, 2024

Indoco Remedies receives EIR from USFDA for Goa Plant-I

The PAI was conducted for two drug product applications (ANDAs) filed from this facility


Supriya Lifesciences received GMP certification from ANVISA Brazil
News | January 06, 2024

Supriya Lifesciences received GMP certification from ANVISA Brazil

The clearance of this audit marks the successful registration of 8 APIs with CADIFA


Eugia's East Windsor facility gets 10 observations from USFDA
Drug Approval | December 25, 2023

Eugia's East Windsor facility gets 10 observations from USFDA

The plant is yet to start commercial operations


Zydus Lifesciences' API site in Ahmedabad. receives 6 observations from USFDA
Drug Approval | December 23, 2023

Zydus Lifesciences' API site in Ahmedabad. receives 6 observations from USFDA

This PAI-cum-GMP USFDA inspection was conducted from December 14 to December 22, 2023