Lupin beefs up with Symbiotec steroids joint venture

India's Lupin Ltd is ramping up its active pharmaceutical ingredient (API) capability by teaming up with compatriot and corticosteroid specialist Symbiotec Pharmalab Ltd.

The two companies have signed a memorandum of understanding for a joint venture in which Lupin will take a majority stake through an equity investment in Symbiotec.

Neither the precise shares in the joint venture, which will carry the Symbiotec Pharmalab name, nor the extent of Lupin's equity participation were disclosed.

Lupin's international business spans finished dosage forms (new chemical entities, generics and herbal products), with an emphasis on anti-tuberculosis (TB) drugs, cephalosporin antibiotics, cardiovascular therapies, anti-asthmatics and non-steroidal anti-inflammatory drugs (NSAIDs); and APIs, where its main strengths are TB treatments, cephalosprins (oral and injectable) and, in the cardiovascular arena, ACE-inhibitors and statins.

The company is in the process of establishing itself as a major global API force in NSAIDs, other cardiovascular therapies and nutritional supplements, it claims.

Lupin also manufactures and markets API advance penultimates.

At present, the company has no presence in the steroids market, either in terms of APIs or formulated products.

This is a market estimated at more than $10bn worldwide and growing at around 8 per cent a year, Lupin noted.

Symbiotec describes itself as one of the largest manufacturers of corticosteroids in India.

Its API range includes beclomethasone dipropionate, betamethasone valerate, budesonide, clobetasol propionate, flumethasone, hydrocortisone acetate, methylprednisolone and triamcinolone acetonide.

Based in Indore, Central India, the company has been manufacturing and marketing corticosteroid APIs since 1995.

Certificates of Suitability for two APIs have been filed with the European Directorate for the Quality of Medicines, and Symbiotec is "all set" for accreditations from the US Food and Drug Administration and other regulatory agencies, it says.

This is the potentially lucrative market Lupin will tap into through the joint venture.

Steroids have very wide applicability, especially in respiratory disease (e.g., asthma), dermatology, arthritis, contraception and fertility enhancement, and can be formulated in a number of ways (injectable, inhaled, liquid, oral, semi-solid), the company pointed out.

Lupin will have access to Symbiotec's entire corticosteroid API range, which will also "become strategic to our [finished] formulations," the company commented.

In turn, Lupin will contribute its own expertise in manufacturing and marketing APIs, it said.

Dr Desh Bandhu Gupta, chairman of Lupin, stated: "We have a proven track record of having achieved a global position in every therapy we have entered at API level.

We would endeavour to repeat the same in the field of steroids as well.

This alliance enables us to aggressively pursue our strategic initiative to participate in the steroids formulation business in chosen global markets including the US and Europe."

A final agreement on the joint venture is expected within the next month.