Receives two 483s; Voluntary Action Indicated only
Mumbai: Pharma Major Lupin Limited (Lupin) announced today that the US FDA inspected its Dabhasa facility from 29th June to 6th July 2016. At the end of the inspection two 483s were issued. Both the observations are minor in nature and corrective and preventive actions were shown to the inspectors during the inspection.
The inspection has been classified as Voluntary Action Indicated (VAI).
About Lupin Limited
Headquartered in Mumbai, Lupin is an innovation led transnational pharmaceutical company producing and developing a wide range of branded & generic formulations, biotechnology products and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership position in the Anti-TB segment.
Lupin is the 5th largest generics player in the US (5.51% generic market share by prescriptions – IMS Health, National Prescription Audit, MAT March 2016) and the 2rd largest Indian pharmaceutical company by market capitalization. The Company is also the 9th largest generic pharmaceutical player in Japan and the 4th largest generic pharmaceutical company in South Africa (IMS Health, March 2016). For the financial year ended 31st March, 2016, Lupin’s Consolidated turnover and Profit after Tax stood at Rs. 137,016 million (USD 2.09 billion) and Rs. 22,707 million (USD 347 million) respectively.
CIN: L24100MH1983PLC029442 Registered Office: Lupin Ltd, 3rd Floor, Kalpataru Inspire, off Western Express Highway, Santacruz (East), Mumbai 400 055.
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Head – Corporate Communications
Ph: +91 98 20 338 555