After a year of uncertainties, respite may be around the corner for Aurobindo Pharma, as it recently received a go-ahead from the US Food and Drugs Administration (FDA) for one of its key units and is expecting the same for another. Both the units were under the scanner of FDA since 2011.

The latest move would not only clear the logjam for many of Aurobindo’s existing products but would also help a string of its proposed drug launches in the US.

The FDA has started approving drugs from Aurobindo Pharma’s unit III and is also expected to audit unit VI, another key facility of the company, in July-September. An Aurobindo Pharma spokesperson has confirmed the development.

“Post USFDA inspection of unit III in March, we have been receiving a few approvals, such as Clopidogrel and Quetiapine, which have been launched,” the Aurobindo spokes-person said.

The USFDA inspected the company’s unit III and unit VI, both located in Andhra Pradesh, in 2010 and found significant violations of its goods manufacturing norms. The regulator then issued a warning letter to the company along with an import alert in 2011. While the FDA had held import of products from Aurobindo Pharma’s unit III for packaging discrepancies, medicines from its unit VI were under a serious import alert since 2011. The regulator not only barred drugs produced at these facilities from the US market, but also held back new approvals from them.

Aurobindo still has 12 generic drug applications pending from its unit III with the FDA. Since it has started getting approvals from this unit, it plans to shift some of these products to unit VII, which came up in October 2010.

“Unit III capacity is optimally utilised and so we are de-bottlenecking by site-transferring some of the products to our new facility at unit VII,” the company spokesperson said.

However, the company’s unit VI, which manufactures cephalosporin-based medicines, continues to be under US import alert. Cephalos-porin, an antibacterial, accounts for a significant portion of the company’s sales in the US. Aurobindo also has a long-term pact with Pfizer to supply cephalosporin.

The drug maker claims it had implemented best practices and made required changes in its unit VI to rectify the manufacturing deficiencies pointed by the regulator. It also engaged a New York-based consultant to audit and validate the changes.

According to a source, Pfizer also assisted Aurobindo to take corrective steps at unit VI. Aurobindo had recently filed the re-validated data with the FDA for unit VI. Now, the regulator has to give a specific date for its visit. The regulator, which will mainly review corrective steps taken by the company, may lift the import ban from the unit, if it is satisfied with the changes.

From its unit VI, Aurobindo had made applications for a total of 24 drugs in the US. Out of this, it received approvals and was already selling 16 medicines in the US, before the FDA generated the import alert in 2011. The company still has eight generic drug applications pending for approval.

According to sector analysts, a green signal from the FDA for its unit VI, would boost its sales in foreign and Indian market. The company’s overall 2011-12 earnings took a hit due to the FDA’s action, resulting in lower exports.

Once issues with the USFDA are sorted out, Aurobindo plans to recapture about 70-80 per cent of the business that it lost due to the ban. The company may also have to face price erosion for its new products as new players entered in its absence

Source: Business Standard

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