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