USFDA inspection at Alembic Pharmaceuticals’ facility at Jarod

None of the observations are related to data integrity and management believes that they are addressable

Sun Pharmaceutical receives warning letter from USFDA for Halol facility

The Halol facility was placed under Import Alert by USFDA.

Balaxi conducts groundbreaking for its Rs 85 crore Hyderabad manufacturing facility

The investment will enable the company to enter European markets as well as enhance margins in current markets

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

Lonza’s API manufacturing facility expansion in Nansha starts commercial operation

Expanded capacity in Nansha, China will support mid-scale manufacturing to ensure a smooth transition between early-phase and large-scale commercial production

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

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

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

Zydus receives EIR with VAI from USFDA for Moraiya facility

The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI)