FDA concludes inspection at Lupin Bioresearch Centre in Pune

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Lupin said that the (FDA) has concluded an inspection of the company’s bioresearch centre in Pune, .

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

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

— 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.”

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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.


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