USFDA inspection at Alkem Laboratories API manufacturing facility located at Mandva

The company has received Form 483 with three observations

Briefs: Aurobindo Pharma and Balaxi Pharmaceuticals

Balaxi Healthcare Ecuador S.A.S. has become a Wholly Owned Subsidiary of the company

USFDA inspection at Piramal Pharma’s Bethlehem facility

Briefs: Mankind Pharma and Sequent Scientific

Mankind Pharma commences the commercial operations newly set-up plant in Udaipur

USFDA conducts inspection at InvaGen manufacturing facility in Central Islip, NY, USA

InvaGen has received 5 inspectional observations in Form 483

Briefs: Caplin Steriles, Zydus and APL Healthcare

Norepinephrine Bitartrate Injection is used for restoration of blood pressure in adult patients

Bajaj Healthcare announces receipt of EIR from USFDA

The company has received the Establishment Inspection Report (EIR) from the USFDA for the Pre-Approval Inspection (PAI) at a manufacturing site situated at Savli, Vadodara, Gujarat, with Zero 483 observations

Hikal posts Q1 FY 24 consolidated PAT at Rs. 6.92 Cr

US FDA approval is in line with de-risking strategy for additional API site to service our global customer base

Lupin posts Q1 FY24 consolidated PAT at Rs. 452.26 Cr

The company has reported total income of Rs. 4836.89 crores during the period ended June 30, 2023

USFDA completes two cGMP inspections at Biocon Biologics' insulins facility in Malaysia

The agency issued a Form 483 with 6 observations for Drug Substance, Drug Product units and Quality Control laboratories