Lupin pharma gets USFDA approval for five drugs

Nagpur: Lupin Pharma is expected to finally start exports from its Mihan-SEZ unit this year. The company has secured United States Food and Drugs Administration (USFDA) approval for five of its drugs, which it plans to start exporting during the current financial year. These are generic drugs for cardiac ailments.

Lupin already makes the branded version of these drugs for the domestic market. With approval of the generic medicines, Lupin is specifically targeting the US market, said a source aware of the development. “The company wants to exploit its expertise as a generic drug maker in the export market,” said the source.

So far, the company was carrying out research and development work at the Mihan plant. Now, commercial production can begin as the approvals from USFDA have been secured. The company has put up 20 drugs for approval out of which it has got USFDA green signal for five. The process continues for the rest. Majority of the drugs relate to cardiac ailments.

“The approvals were secured without a single observation from the USFDA, which is a major achievement for the company,” said a source. The Mihan unit has capacity to make 8 to 10 billion tablets of these five medicines.

The 25 acre plant in Mihan has dedicated 15 acres for tablets and 9 acres for injectables. The injectables for cancer treatment are part of the company’s future plans. Under development at present, the injectables are expected to be put up for approval after two years.

Lupin also had a plan to expand its units in Mihan by taking additional land in the SEZ. The project has, however, been put on hold. It had initiated negotiations with Maharashtra Airport Development Company (MADC) for the extra land. Sources said the plans have been put on hold at present. There are chances that the biotech project may be set up at Vizag, however, a final decision has not been taken on the project yet.