Cipla Patalganga facility gets VAI classification from USFDA
Mumbai: Through a recent BSE filing, Cipla has informed that the United States Food and Drug Administration (USFDA) has classified the routine current Good Manufacturing Practices (cGMP) inspection at the Patalganga manufacturing facility as Voluntary Action Indicated (“VAI”).
Voluntary action indicated (VAI), which means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
The USFDA had conducted the inspection from 28th March 2024 to 4th April 2024 and was issued six inspectional observations in Form 483.
Established in 1935, Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolio in its home markets of India, South Africa, North America, and key regulated and emerging markets. It has strengths in the respiratory, anti-retroviral, urology, cardiology, anti-infective, and CNS segments. It has 47 manufacturing sites around the world which produces 50+ dosage forms and 1,500+ products using cutting-edge technology platforms to cater to its 80+ markets.
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