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Business / Mon, 29 Jun 2026 ETPharma.com

Dr Reddy’s biologics plant gets 7 observations from FDA

By ,ET PharmaJoin the community of 2M+ industry professionals. Subscribe to Newsletter to get latest insights & analysis in your inbox. All about ETPharma industry right on your smartphone! Download the ETPharma App and get the Realtime updates and Save your favourite articles. It manufacturers pre-filled syringes (PFS) for multiple international markets, such as the US, Europe, Latin America, South Africa among others.

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ET Pharma

Join the community of 2M+ industry professionals. Subscribe to Newsletter to get latest insights & analysis in your inbox. All about ETPharma industry right on your smartphone! Download the ETPharma App and get the Realtime updates and Save your favourite articles.

Mumbai: Dr Reddy’s Laboratories’ Bachupally, Hyderabad-based biologics manufacturing facility has received seven observations from the US Food and Drug Administration In an intimation to the stock exchange last week, the drugmaker disclosed that, under a Pre-License Inspection, conduced between June 16 and June 25, the US drug regulator issued a “Form 483 with seven observations.”Without disclosing the nature of observations, the company intend address them within the stipulated time.Dr Reddy's biologics facility is equipped with mammalian and bacterial cell culture units, including advanced stainless steel bioreactors. It manufacturers pre-filled syringes (PFS) for multiple international markets, such as the US, Europe, Latin America, South Africa among others.

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