Health Secretary Srivastava chairs meeting with states/UTs on quality and rational use of cough syrups

States exhorted to ensure rational use of cough syrups, particularly among children, as most coughs are self-limiting and do not require pharmacological treatment

FDA supports new ANDA prioritization pilot to support US generic drugs

FDA issues CRL for Sentynl’s copper histidinate for treatment of Menkes disease

DMMA warns regulatory burden threatening Gujarat’s pharma MSMEs

The association called for an end to the constant issuance of regulatory circulars that make operations unpredictable and capital-intensive.

Zydus receives EIR for oncology injectable manufacturing facility in Ahmedabad SEZ1

The facility has been classified as Voluntary Action Indicated

Alembic Pharmaceuticals receives EIR for API - I and API - II facility located at Panelav

The inspection was carried out between May 26, 2025 and May 31, 2025

Briefs: Alembic Pharmaceuticals and Tyche Industries

Alembic receives EIR from USFDA for facility at Panelav

FDA prohibits Sun Pharma's Halol Plant from exporting drugs to US

Sun Pharma's Halol plant gets OAI classification from US FDA inspection

Zydus Lifesciences gets 4 USFDA observations for Jarod Injectable facility

Zydus will work closely with the USFDA to address and resolve the observations in an expeditious manner

Apitoria Pharma receives 5 observations from USFDA for API facility

At the end of the current inspection, a 'Form 483' was issued with 5 observations which are procedural in nature and no data integrity issues were reported