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Results For "inspection"

465 News Found

Sun Pharmaceutical receives warning letter from USFDA for Halol facility
Drug Approval | December 19, 2022

Sun Pharmaceutical receives warning letter from USFDA for Halol facility

The Halol facility was placed under Import Alert by USFDA.


Briefs: Jubilant Pharmova and Apollo Hospitals Enterprise
News | December 15, 2022

Briefs: Jubilant Pharmova and Apollo Hospitals Enterprise

The company will submit an action plan on the observations and will engage with US FDA for next steps.


Alembic receives EIR for oncology injectable formulation facility at Panelav
Drug Approval | December 12, 2022

Alembic receives EIR for oncology injectable formulation facility at Panelav

This was a pre-approval inspection to cover our Oncology Injectable drug products for which ANDAs were filed with USFDA


Briefs: Piramal Enterprises and Shilpa Medicare
News | December 02, 2022

Briefs: Piramal Enterprises and Shilpa Medicare

Shilpa Medicare Ltd's finished dosage form manufacturing facility, Unit IV, situated at Pharma SEZ, Jadcherla, Telangana has received Health Canada GMP approval


WuXi STA launches parenteral formulation manufacturing line at Wuxi
News | December 01, 2022

WuXi STA launches parenteral formulation manufacturing line at Wuxi

This is the second line opened this year for parenteral drug product clinical and commercial manufacturing, with an annual capacity of 10 million units


Briefs: IOL Chemicals and Cipla
News | November 27, 2022

Briefs: IOL Chemicals and Cipla

Government of India has granted a patent for invention entitled "An improved safe process for the preparation of Sartan drugs of Formula I".


USFDA inspects Lupin's Mandideep Unit-1 facility
News | November 25, 2022

USFDA inspects Lupin's Mandideep Unit-1 facility

The inspection of the facility resulted in issuance of a Form-483 with eight observations each for the Drug Product facility and API facility at the site


USFDA issues warning letter to Glenmark's Goa manufacturing facility
News | November 24, 2022

USFDA issues warning letter to Glenmark's Goa manufacturing facility

The company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility


Aurobindo Pharma receives 10 observations for Unit IX
Drug Approval | November 21, 2022

Aurobindo Pharma receives 10 observations for Unit IX

The company had responded to the agency and carried out the required corrective actions.