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Dr Reddy's API plant receives USFDA 483 with nine observations

Dan Stanton

By Dan Stanton+


Inside a Dr Reddy's API facility
Inside a Dr Reddy's API facility

Dr Reddy’s says an API plant in India is unlikely to be subject to further regulatory enforcement after receiving a US FDA 483 with nine observations.

The Srikakulam facility in the Andhra Pradesh region of India was inspected by the US Food and Drug Administration (FDA) last week resulting in a Form 483 with nine observations, Shilpi Lathia – a company spokesperson – told

“The observations were largely related to procedural and other compliances of the plant system,” she explained. As such “there is no implication on manufacturing and at this stage production continues as normal,” she added.

When asked what Dr Reddy’s Laboratories is doing to fix the issues, Lathia told us it is currently responding to the agency with its remediation plans and the firm is “confident it won’t lead to any further enforcement” such as a Warning Letter or import alert.

The plant manufactures bulk active pharmaceutical ingredients (APIs) - including bromfenacna, celecoxib, ibuprofen, ketorolac tromethamine, naproxen, naproxen sodium, glimepirid, linagliptin, liraglutide, and nateglinide - used in Dr Reddy’s finished formulated drugs for export to the US and EU.

This is not the first time Dr Reddy’s has fallen foul with the US. In August the US Government’s Consumer Product Safety Commission accused the firm of having violated childproof packaging rules, while an inspection of an API plant in Mexico in 2010 was followed up with an FDA warning letter banning imports from the site.

Continued investment

Originally constructed in 2006 as part of a $100m investment in upping its network capacity, the site located in the Devunipalavalasa Special Economic Zone (SEZ) has been joined by a new oral solid dosage manufacturing facility last year.

According to Dr Reddy’s end of year report , the firm has “begun filing some of our new DMFs from this location and [it expects] to file some more during the year ending March 31, 2015.”

It continues: “To meet growing demand in regulated markets, we are in the process of obtaining approvals from the U.S. FDA for products to be manufactured from our recently commissioned oral solid dosage form facility.

“The new plant is intended for the manufacture of new molecules, and certain high volume products of ourGlobal Generics segment.”

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