US FDA clears troubled API plants following two Form 483s, says Dr. Reddy’s

By Flora Southey contact

- Last updated on GMT

Dr. Reddy’s Laboratories has announced receipt of a US FDA establishment inspection report regarding two active pharmaceutical ingredient plants in Hyderabad, India.

On March 9, 2018, the US Food and Drug Administration (FDA) issued Dr. Reddy’s a Form 483​ with five observations after an inspection of its Bollaram facility in the Indian state of Telengana earlier that month.

One week later, the firm announced receipt​ of an FDA Form 483 with four observations​, following a regulatory inspection of its active pharmaceutical ingredient (API) Plant 1 in Jinneram Mandal, Telangana.

In a Bombay Stock Exchange filing issued last week, the firm stated it had “received an establishment inspection report from the US FDA, for both of the above-referred facilities.”

“The establishment inspection report (EIR) indicates clearance from the US FDA for both these sites,” ​a Dr. Reddy’s spokesperson told us, adding that “no further actions” ​are required.

The regulatory nod follows recent drug manufacturing and commercialisation issues for the India-headquartered firm. Last week​, Indivior sought an injunction against Dr. Reddy’s to prevent further sales of its generic buprenorphine and naloxone sublingual film product in the US.

And yesterday​, we reported impurity issues had prompted Dr. Reddy’s to voluntarily recall more than 236,000 bottles of statins made at its troubled Srikakulam facility​.

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