Lupin receives USFDA warning for Tarapur API plant
- Lupin’s Maharashtra factory was cited by the US health authorities for production errors, including inadequate documented cleaning procedures.
- The US Food and Drug Administration (USFDA) warned the Tarapur (Thane) active pharmaceutical ingredient facility of many violations in a warning letter (API).
- “This warning letter outlines substantial breaches from current good manufacturing practise (CGMP) for active pharmaceutical ingredients (API),” the US health authorities said.
- “Because your techniques, facilities, or controls for manufacturing, processing, packaging, or holding do not adhere to CGMP, your API is contaminated…” March 22–April 4, 2022, the USFDA examined the factory.
- When a manufacturer severely violates US health standards, the regulator issues a warning letter.