Alkem API plant in Gujarat gains EIR approval from US FDA

Published: 16-Mar-2016

Indian firm started strengthening its US presence in 2010

One of Alkem Labs' manufacturing plants in Gujarat, India has obtained Establishment Inspection Report (EIR) approval from the US health regulator.

The plant manufactures active pharmaceutical ingredients (APIs) and was inspected in September 2015.

The facility at Mandva is Alkem's sixth plant to receive US FDA approval. The others include formulation manufacturing facilities at Baddi in Himachal Pradesh, Daman and St Louis in the US and API manufacturing facilities at Ankleshwar in Gujarat and California in the US.

Alkem has expanded to emerge as a global player. In the domestic arena, the company’s strength lies in anti-infectives, gastro-intestinal, pain relief, as well as in vitamins, minerals and nutrients, where it has built a strong product portfolio and enjoys a leadership position.

The majority of the firm's sales are from the ‘acute’ segment, which offers comparatively lower margins. It is the volumes that play a crucial role and have been supporting the segment's growth. The firm is working towards developing its ‘chronic’ portfolio in the gynaecology, diabetic care, dermatology and cardiology streams.

Alkem started strengthening its US presence in 2010, first by acquiring Pharma Network to build a marketing platform, followed by Norac Pharma’s API manufacturing assets and in June 2015, Long Pharmaceuticals’ formulation manufacturing assets.

Since then, the firm has filed 69 abbreviated new drug applications (ANDAs), of which 21 are approved, three have received tentative approvals, while 45 are awaiting approvals. There are about 30 Para-IV filings.

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