Lupin receives EIR from FDA for its API manufacturing facility in Vizag
The inspection closed with the facility receiving an inspection classification of NAI
The inspection closed with the facility receiving an inspection classification of NAI
The inspection closed with zero observations
The company has now received the Establishment Inspection Report (EIR) indicating closure of the inspection
Jain will have oversight of Brinton's domestic operations, including business development, sales, and marketing
The US FDA in its communication mentioned it may withhold approval of any pending applications or supplements in which this facility is listed.
Capnopharm’s new CapnoPen is the first PIPAC nebulizer to obtain CE marking under the new MDR regulation 2017/745
This is the second US FDA GMP inspection of this facility within one year
The USFDA had classified Strides Puducherry facility as OAI in May 2019 followed by issuing a warning letter to this site in July 2019.
This latest audit re-emphasizes Hikal's commitment towards maintaining the best in class quality, compliance and regulatory standards across our manufacturing sites
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