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Expect FTC Nod For USD 900 Million Sandoz Deal: Aurobindo Pharma

Aurobindo Pharma, India’s second-largest drug maker, on November 13 said it is expecting the nod of US antitrust watchdog Federal Trade Commission (FTC) for its $900 million Sandoz deal in the next few weeks.

Sandoz is the generic arm of Swiss-pharma giant Novartis.

“Things have been moving along positively and we believe that we have substantially addressed all the requirements to obtain (FTC) approval,” said Swami Iyer, CFO – North America, Aurobindo Pharma, at the company’s earnings call.

Iyer said the company expects the approval to come in the next few weeks, possibly before December.

The company had announced the acquisition of Sandoz’s dermatology and formulations business in September last year, making it the largest outbound deal by an Indian pharma company.

However, the closure of the deal got delayed for reasons the company never made public. It hinted that the delay was on account of queries related to product and their transfers.

Aurobindo also clarified that it is expecting re-inspection of its three manufacturing facilities, which are under  USFDA scanner in the fourth quarter of FY20. USFDA issued warning letter to Unit-11, and classified Unit-9 and Unit-11 as official action indicated (OAI).

The warning letter and OAI have put lid on around 20 new approvals filed from these  plants.

“With regards to closure of CAPAs (corrective and preventive action), we are sending our response (to USFDA) before November 15,” said N Govindarajan, MD of Aurobindo Pharma.-Money Control

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