Narrowing the Geographic Divide in API Sourcing

Contract manufacturers deploy a business model using operations in the US and Western Europe with facilities in Asia.
Mar 02, 2009
Volume 33, Issue 3

The globalization of contract manufacturing organizations (CMOs) supplying active pharmaceutical ingredients (APIs) and intermediates is an ongoing phenomenon. The business models of these suppliers varies from companies seeking to be low-cost suppliers of early-stage intermediates and generic APIs to companies offering advanced intermediates, custom synthesis of APIs for innovator drug companies, and other value-added services such as formulation development and secondary manufacturing. These functional models also have geographic components. A CMO may have its operations exclusively in the United States or Western Europe, or be based entirely in emerging markets in Asia, Eastern Europe, and Latin America. Several CMOs are using a hybrid model that lies between these two approaches by basing certain functions in established markets such as process development, logistics, customer relations, and in certain cases, manufacturing, with other development and manufacturing operations abroad. These hybrid models offer the potential advantage of combining lower-cost production from facilities in emerging markets with operations in established markets.

India-based CMOs expand

Patricia Van Arnum
Piramal Pharma Solutions (Mumbai) (formerly NPIL Pharma), the contract development and manufacturing division of Piramal Healthcare (Mumbai), is a fast-growing company that is actively building its contract primary and secondary manufacturing capabilities. The company was one of the first India-based CMOs to acquire Western manufacturing assets. It acquired Rhodia's inhalation anesthetics business in 2004 and Avecia's custom-manufacturing business in December 2005. The Avecia acquisition provided Piramal with the following: early-phase API development capabilities in Huddersfield, United Kingdom; commercial-scale production capacity for advanced intermediates and APIs in Huddersfield and Billingham, UK; high-potency API manufacturing capacity in Grangemouth, Scotland; and small-scale API production capacity in Aurora, Ontario. Piramal also formed a new unit to focus on applying new technologies for process development and production of APIs using biocatalysis, chemocatalysis, its catalyst-based racemization technology, "SCRAM," and flow processing.

In 2006, Piramal Healthcare acquired the Morpeth, Northumberland, UK, manufacturing facility of Pfizer. The site has API and formulation manufacturing production capacity and supply-chain capabilities for APIs, finished dosages, packaging, and distribution. With the Morpeth acquisition, Piramal secured a supply agreement with Pfizer through November 2011.

Piramal followed these acquisitions with organic growth through several recent expansions. In early 2008, the company commissioned its sixth high-potency-substance production suite at its Grangemouth facility. The new suite is optimized for GMP manufacture of antibody drug conjugates of batch sizes of 500–1000 g, and can produce as much as 50 kg annually. Also in 2008, Piramal Pharma Solutions set up capacity to supply antibody drug conjugates from batch sizes of 200–1000 g in Phase III and commercial scales.

On the formulation side, Piramal invested significantly over a three-year period to increase its early-phase (development) and late-phase (manufacturing) formulation services in the UK and India. Piramal invested in its early-phase pharmaceutical development and scale-up business unit at its facility in Ennore, Chennai, India in 2007.

Piramal Pharma Solutions made several investments to support its clinical trial service capabilities. In August 2008, Piramal launched clinical trials services from the Morpeth site. The services use a 13,000-ft2 clinical trials packaging and distribution facility for primary packaging of solid-dosage forms, including multidose blistering and walleting. Secondary packaging booths are set up for the labeling and assembly of various dosage forms. Further flexibility exists within the current footprint for future doubling of primary and secondary packaging capacity.

The company also opened a new 50,000-ft2 formulation development and clinical trial materials center in Ahmedabad, India, in December 2008. The facility will begin producing GMP supplies beginning in the second quarter of 2009.

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