FDA concludes inspection at Lupin Bioresearch Centre in Pune

Lupin said that the US Food and Drug Administration (FDA) has concluded an inspection of the company’s bioresearch centre in Pune, Maharashtra.

The inspection was completed without any observation, said the Indian pharma company.

Lupin’s bioresearch centre carries out bioavailability/bioequivalence (BA/BE), pharmacokinetics/pharmacodynamics (PK/PD), in-vitro BE, and biosimilar studies.

Nilesh Gupta — Lupin Managing Director said: “We are pleased to announce that the Lupin Bioresearch Centre has successfully undergone its seventh consecutive onsite inspection, reaffirming our commitment to patient safety and our superior quality and compliance standards.”

The inspection at the Lupin Bioresearch Centre follows the pre-approval and GMP inspection of the FDA at the company’s API manufacturing plant in Visakhapatnam, Andhra Pradesh, which was also completed without any observations.