Akorn, Aurobindo get warning letters; Sun Pharma’s data called into question

By PharmaCompass

2019-06-27

Impressions: 125 Article

In October 2018, German drugmaker Fresenius Kabi had won the case against American drug company Akorn Inc, as a US court had upheld its decision to terminate its agreement to merge with Akorn because of data integrity issues at the latter’s facilities.

Since then, Akorn has suffered a series of setbacks as the firm announced that its facility located in Somerset, New Jersey, received a warning letter from the FDA following an inspection conducted in July and August 2018.

This warning letter is the second one that Akorn has received this year. In January, the agency had issued a warning letter to Akorn’s other manufacturing plant in Decatur, Illinois after the drugmaker did not resolve previously highlighted violations at the plant.

Akorn wasn’t the only one receiving a warning letter. Two weeks after data-integrity concerns emerged at Aurobindo Pharma’s Unit 3 operations in Hyderabad, the firm informed the bourses that an active pharmaceutical ingredient (API) facility — Unit XI — had received a warning letter. The action follows news last month that the American drug regulator had classified three plants of the Indian drug major as OAI (short for Official Action Indicated), necessitating regulatory and administrative action.

The FDA’s action came after it inspected the company’s plants that make APIs (Units 1 in Telangana and Unit 11 in Andhra Pradesh, India) and an intermediate facility (Unit 16, in Telangana) between January and March this year.

Another Indian drug giant, Sun Pharma’s facility in Dadra was inspected in March and according to The Indian Express, which reviewed the 10-page Form 483 issued to the site, the FDA found several deficiencies, including those relating to medicine quality as well as data collection. Among the concerns raised are those regarding electronic records used, as they “do not meet requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.”

Manufacturing concerns also derailed Glenmark Pharmaceutical’s plans to get an approval for the New Drug Application of Ryaltris as the FDA cited deficiencies in the Drug Master File pertaining to one of the APIs used in the product and at its manufacturing facilities.

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