Shifting Patterns in Sourcing - Pharmaceutical Technology

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Shifting Patterns in Sourcing
The pharmaceutical supply chain lengthens as generic drug manufacturers build production platforms offshore and CMOs position in India and China to meet demand for lower-cost production.

Pharmaceutical Technology

Lonza (Basel, Switzerland) is investing $200 million over the next several years to build a multipurpose API and intermediates plant complex with large- and pilot-scale production capabilities in Nansha, Guangzhou, China. It also opened a new research and development center for intermediates and APIs in Nansha.

NPIL Pharmaceuticals, part of Nicholas Piramal India. Ltd. (Mumbai, India), is on track with a goal to increase the revenues of its custom-synthesis business. In 2006, it acquired the Morpeth, Northumberland, United Kingdom manufacturing facility of Pfizer, Inc. (New York, NY). The site has production and supply-chain capabilities for APIs, finished dosages, packaging, and distribution. With the Morpeth acquisition, NPIL Pharma secured a supply agreement with Pfizer through November 2011.

The Morpeth transaction was NPIL's third acquisition of European-based manufacturing assets. It acquired Rhodia's inhalation anesthetics business in 2004 and Avecia's custom-manufacturing business in December 2005.

To further build its custom-synthesis business, in 2006, NPIL formed a new dedicated unit, NPIL Innovations or NPIL(i), to focus on developing and applying new technologies used in the process development and production of APIs. NPIL(i) will have bases at NPIL's facilities in the United Kingdom and at its new research center in Mumbai. The company plans to expand its scientific and technical staff to 50 people. The unit focuses on biocatalysis, chemocatalysis, catalyst-based racemization technology, "SCRAM," and flow processing.

Like other Indian companies, NPIL is backward-integrated in China. It opened an office in Shanghai in August 2006 to coordinate sourcing activities from China.

NPIL Pharma has invested roughly $50 million over the past three years as part of its early-phase (development) and late-phase (manufacturing) formulation services in the United Kingdom and India, and plans a similar investment over 2007–2009. The investment includes a new sterile supplies pilot plant, which is scheduled to come on stream in Mumbai, India in the fourth quarter of 2007.

Degussa AG (Düsseldorf, Germany), formed a custom-manufacturing joint venture with Lynchem Co., Ltd. (Dalian, Liaoning Province, China). Lynchem, with 2005 sales of roughly $45 million, has 800 m3 of reactor capacity at a 50-hectare facility in Dalian.

The joint venture is part of a strategy of what Degussa terms "horizontal integration" for leveraging manufacturing assets in Asia for cost-competitive manufacturing of on-patent intermediates, steps in API synthesis, and off-patent APIs. Degussa will focus its existing European custom-manufacturing sites on producing high-value regulated intermediates and on-patent APIs. Consistent with that approach, Degussa agreed to sell Raylo Chemicals, a custom manufacturer of APIs and advanced pharmaceutical intermediates, to Gilead Sciences (Foster, City, CA).

Degussa also has a long-term, nonexclusive agreement with the Indian custom manufacturer Hikal, Ltd. (Mumbai, India), under which Hikal will manufacture advanced intermediates and APIs for Degussa.

Last year, Hikal commissioned a new pilot Plant at Taloja, a new API manufacturing unit at Bangalore, and a CGMP kilo laboratory at Jigani. The new pilot plant at Taloja is manufacturing an agrochemical product. A full-scale multipurpose agrochemical plant is expected to be commissioned by 2008. The Bangalore manufacturing unit will produce a new veterinary drug; the multiproduct API plant is expected to start full-scale production by the end of 2007.


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