Strides Puducherry facility receives EIR from USFDA

The USFDA had classified Strides Puducherry facility as OAI in May 2019 followed by issuing a warning letter to this site in July 2019.

Indoco receives EIR for its Plant I manufacturing facility in Goa

Indoco expects this change in compliance status to pave the way for approvals of ANDAs submitted from this site.

Jubilant Pharmova receives VAI from USFDA for its API manufacturing facility

Based on this inspection and the USFDA VAI classification, this facility is in compliance with regard to current good manufacturing practices (cGMP)

Strides flagship facility in Bangalore receives USFDA inspection closure

Aurobindo Pharma gets VAI classification from USFDA for Telangana plant

Company's Unit - IX, an API intermediate facility situated at Sangareddy District, Telangana, has now been classified as Voluntary Action Indicated

USFDA conducts PAI and GMP inspection of Piramal Pharma's Sellersville facility

The company remains committed to maintain the highest standards of compliance and will work closely with the agency to comprehensively address all the observations

USFDA inspects Piramal Pharma Lexington facility

The company is preparing a detailed response to the observations, which will be submitted to the USFDA within the stipulated timelines.

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)

Jubilant receives EIR from USFDA for its radiopharmaceuticals manufacturing facility Montreal Canada

With the receipt of the EIR, the inspection stands successfully closed.

Lupin’s Somerset manufacturing plant Receives EIR from US FDA

The US FDA has determined that the inspection classification of the facility is Voluntary Action Indicated