US FDA issues Form 483 to Lupin, Aurobindo Pharma plants

Lupin says US FDA had noticed 8 violations of good manufacturing practices, One of Aurobindo Pharma’s Hyderabad units was pulled up for 7 violations


Photo: Bloomberg
Photo: Bloomberg

Mumbai: Two Indian drugmakers came under increased scrutiny of the US Food and Drug Administration (FDA) as they received so-called Form 483s. Lupin Ltd told stock exchanges on Tuesday the FDA had noticed eight violations of good manufacturing practices. One of Aurobindo Pharma Ltd’s Hyderabad units was pulled up for seven violations, according to information on the drug regulator’s website.

Shares of both companies fell. The Lupin stock closed 2.25% lower at Rs1,250.70 on BSE, while Aurobindo’s fell 1.28% to Rs595.65. The benchmark Sensex ended little changed at 29,933.25 points.

“We are in (the) midst of putting together a response to address the observations,” Lupin said. The firm has multiple facilities that cater to the US market and undergo periodic routine inspections in the normal course of business.

The US FDA issues a Form 483 if its investigators spot any conditions that in their judgment may constitute violations of the US Food Drug and Cosmetic (FD&C) Act and related Acts.

According to a CNBC-TV18 report, the FDA observations for the Aurangabad unit include a lack of proper investigation of market complaints and adverse drug experiences, a lack of written review procedure for stored data, ineffective testing of finished products, and a lack of certain processes to control contamination.

“The observations pertain to some market complaints regarding contamination of the drug and its effect on the consumer, some data-related issues and some manufacturing protocols not being followed. The plant is estimated to be contributing around 10-15% to the company’s US sales. Thus, on the overall basis the plant’s contribution is not that much,” said Sarabjit Kour Nangra, vice- president research-pharma, Angel Broking.

In the quarter ended December, Lupin’s US sales grew 53% year-on-year to $316 million.

In April, Lupin’s Goa plant was issued a Form 483 by the FDA, citing three observations related to violation of norms.

In Aurobindo’s case, the regulator noticed two key lapses: there were not enough controls over computers and who accessed them, and lack of procedures to prevent microbiological contamination of products purporting to be sterile. The FDA also observed that buildings and manufacturing were not maintained in a good state.

The issues highlighted by the FDA at the unit do not appear to be very severe and the company will be able to address them soon, said a research analyst at a domestic brokerage house, who did not wish to be named.

According to Aurobindo Pharma, product filings with the FDA from unit-IV were 75 as on 31 December 2016, of which the company has got marketing approval for 38 products. On 19 April the FDA had issued Form 483 to the company’s unit-III in Hyderabad, used for manufacturing oral formulations, with six observations relating to violation of norms.

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