FDA raises cGMP concerns in OAI letter issued to Lupin’s sites in India, US

By PharmaCompass

2019-03-21

Impressions: 163 Article

In yet another blow to Indian generic major Lupin, two of its manufacturing sites — one in India and another one in the United States — received ‘Official Action Indicated’ (OAI) letters from the US Food and Drug Administration (FDA).

The firm informed the stock exchange that it had received a letter from the FDA classifying the inspection conducted at the company’s Mandideep (Unit 1) and Somerset (New Jersey) facilities in December 2018 as OAI, which means the facilities are considered to be in an unacceptable state of compliance with regard to current good manufacturing practice (cGMP).

According to a Lupin spokesperson, the letter Lupin received from the FDA is a 90-day facility classification decisional letter. “We are taking corrective actions and communicating them to the FDA as we strive towards a positive outcome,” the spokesperson informed PharmaCompass through an email.

Lupin’s Mandideep plant has two units. Unit-1 makes cephalosporin active pharmaceutical ingredient (API) and cephalosporin solid oral dosage (antibiotic) and unit-2 produces cardiovascular Pril APIs (to treat high blood pressure).

Although the Mandideep plant is not a major contributor to its revenues and there are no new DMF and ANDA applications pending review or approval from the Mandideep (Unit 1) facility and the company does not believe that this action will have an impact on disruption of supplies or on the existing revenues from operations of this facility, manufacturing problems continue to plague Lupin.

The firm’s operations in Indore and Goa received warning letters in 2017 and less than a month ago, PharmaCompass had reported on how following the warning letter issued in 2017, an FDA Form 483 posted by the agency had highlighted recurring compliance issues at the Indian drug major’s Goa facility.

In addition to Lupin, there were also reports of concerns at Aurobindo’s sterile manufacturing operations in India. According to BloombergQuint, the FDA had 11 observations in a Form 483 issued to its operations at Unit 16 in Telangana.

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