Dose Manufacturing Capacity Growing in Low-Cost Countries - Pharmaceutical Technology

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Dose Manufacturing Capacity Growing in Low-Cost Countries
FDA approvals renew the threat of competition from India and China.


Pharmaceutical Technology


NextPharma (Surrey, UK) is leveraging India's cost advantage by establishing a joint venture with Centaur Pharmaceuticals (Mumbai). The joint venture has built a solid-dose manufacturing facility in Pune, India, that will process tablets and capsules and will have capabilities for fluid-bed and wet granulation, as well as bottle and blister packaging. NextPharma is actively involved in developing, implementing, and maintaining the plant's quality systems and will handle sales and marketing to customers in Europe and the US. The company's strategy is to use its Pune facility to service clients requiring standard-dose products for which cost is a major consideration, while using its European sites for higher-value manufacturing such as high potency solid-dose and injectable products.

Custom's and NextPharma's initiatives do not yet represent an industry trend. In APIs, only a few companies—notably Lonza (Basel, Switzerland) and Albany Molecular Research (New York)—have moved to set up owned GMP operations in India and China.

Most pharmaceutical chemical manufacturers have preferred to leverage the low-cost country opportunity by sourcing non-GMP starting materials and intermediates or establishing joint ventures. Dose manufacturers are still studying the market and considering their options; larger CMOs are trying to sort out issues with their current plant networks before deciding to invest in further capacity offshore.

NextPharma lands in America

Regarding NextPharma, the company recently announced its acquisition of BioServ (San Diego, CA), a provider of development and manufacturing services for injectable products. BioServ's capabilities are limited to clinical scale but include aseptic filling and lyophilization as well as sterile powder filling. The company said the BioServ operation will complement its development capabilities in Braine L'Alleud, Belgium, where it has commercial-scale injectable manufacturing facilities and is about to open a development center for injectable products. Financial terms were not disclosed.

The acquisition is an important step in NextPharma's efforts to penetrate the North American market. Its business has largely been confined to manufacturing facilities in Germany, Belgium, and France, most of which have not yet gained FDA approval (an FDA inspection is expected soon at one of its facilities). The company added a US-based sales representative two years ago and has begun exhibiting at US trade shows. The BioServ acquisition will provide better access to North American clients, but the company may need commercial-scale capabilities there to fully exploit the market opportunity.

NextPharma was established 10 years ago as a private-equity-backed CMO. In a strategy similar to that of Patheon (Ontario, Canada), it has grown through acquisition of redundant facilities from major pharmaceutical companies as well as by acquiring other CMOs. Its network of sites in Europe are targeted at specialty dosage forms such as high-potency solid-dose products and specialty packaging configurations. The company's entry into the US market, combined with its solid dose joint venture in India, is transforming it into one of the few global players in contract dose manufacturing.

Jim Miller is president of PharmSource Information Services, Inc., and publisher of Bio/Pharmaceutical Outsourcing Report, tel. 703.383.4903, fax 703.383.4905,
, http://www.pharmsource.com/.


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