Briefs: Morepen Laboratories and Zydus Lifesciences

The company is addressing these observations

Lupin announces completion of pharmacovigilance inspection by USFDA

The inspection included a comprehensive scrutiny of practices and procedures for reporting of adverse events of Lupin’s marketed products worldwide

Briefs: Lupin and Alembic

Lupin Bioresearch Centre conducts BA/BE, PK/PD, In-vitro BE and biosimilar studies.

Shilpa Medicare gets 2 minor observations from USFDA for Unit VII, Analytical Services Division

The company will be submitting the responses to US FDA observations within stipulated timeline

Briefs: Alkem and Krsnaa Diagnostics

Alkem has submitted a detailed corrective and preventive action (CAPA) plan to the regulator within the stipulated timelines.

Briefs: Piramal Pharma, Alembic Pharmaceuticals

USFDA has issued an Establishment Inspection Report (EIR) for Piramal Pharma Limited manufacturing facility located at Lexington (Kentucky, USA) and the inspection has now been successfully closed by the USFDA

Sun Pharmaceutical receives warning letter from USFDA for Halol facility

The Halol facility was placed under Import Alert by USFDA.

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 completes pre-approval inspection of BHL's Vadodara facility

The pre-approval inspection of USFDA was completed successfully with ZERO 483 observation of the manufacturing facilities of Bajaj Healthcare Limited

Sun Pharmaceutical gets OAI from USFDA for Mohali facility