Moneycontrol

Budget 2023Budget 2023

PARTNERS

  • Tata AIA Life Insurance
  • Hafele
  • Motilal Oswal
  • SMC Global Securities Limited
  • SBI Life
  • DSP Mutual Fund
Upcoming Event : LeapToUnicorn - mentoring, networking and fundraising for startups. Register now
you are here: HomeNewsTrendsHealth

USFDA pulls up Aurobindo Pharma for manufacturing lapses at API plant

In a letter to company’s Managing Director Narayanan Govindarajan, the US health regulator noted that its inspectors during an inspection between August 2-12, 2021, found significant deviations from standard manufacturing practices for active pharmaceutical ingredients (API) at the company’s Doultabad-based plant.

January 27, 2022 / 02:50 PM IST

The US Food and Drug Administration (USFDA) has issued a warning letter to Aurobindo Pharma for violating current good manufacturing practice norms at its Telangana-based plant.

In a letter to company’s Managing Director Narayanan Govindarajan, the US health regulator noted that its inspectors during an inspection between August 2-12, 2021, found significant deviations from standard manufacturing practices for active pharmaceutical ingredients (API) at the company’s Doultabad-based plant.

The significant violations included failure to evaluate the potential effect that changes may have on the quality of intermediates and API, the USFDA stated.

The US health regulator said the Hyderabad-based drug firm failed to fully evaluate whether increasing acceptable starting material would impact the quality of the API.