US-based Mylan Inc today said the USFDA warning letter to Agila Specialties over violation of manufacturing norms in one of its plants will not affect the Rs 5,168 crore deal to acquire the Bangalore—based firm.

Mylan said it is aware of the corrective actions being taken by Agila to address USFDA’s observations at the sterile manufacturing facility site that formed the basis for the warning letter.

“Based on what we know today, we continue to expect to close the Agila acquisition in Q4 2013 and do not expect that the matter will have a material impact on our financial assumptions with regard to our combined business,” a company spokesperson told PTI in an emailed response.

The USFDA had inspected the Agila facility in June this year resulting in the issuance of ‘Form FDA 483’ with observations.

“Based on our discussions with Agila and current understanding of the issues, we are confident that Agila and Mylan will be able to work closely with FDA to fully address the observations in the agency’s letter and resolve this matter,” the spokesperson said.

Yesterday, Strides Arcolab, the parent firm of Agila Specialties had said US health regulator has issued a warning letter against a manufacturing facility of its subsidiary.

Earlier this month, the government had approved Mylan’s Rs 5,168 crore deal to fully acquire Agila Specialties from Strides Arcolab. The companies had announced the deal in February.

While announcing the deal in February this year, the US—based firm had said that Agila will bring a broad product portfolio of more than 300 filings approved globally and marketed through a network covering 70 countries, including 61 abbreviated new drug applications (ANDAs) approved by the US Food and Drug Administration (USFDA).

Agila currently produces drugs across nine manufacturing facilities in India, Brazil and Poland, eight of which have been approved by the FDA.

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