CMOs Make Select Investments in Primary and Secondary Manufacturing - Pharmaceutical Technology

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CMOs Make Select Investments in Primary and Secondary Manufacturing
Contract manufacturers and pharmaceutical ingredient suppliers proceed with select investments in biologics manufacturing, small-molecule synthesis, and formulation as the industry prepares for CPhI Worldwide in Milan.

Pharmaceutical Technology

Evotec. Evotec AG (Frankfurt, Germany) and Research Support International Limited (RSIL) formed a joint venture, Evotec-RSIL Ltd., in Thane, India, to design, synthesize, and manage compound libraries as a service. In addition, Evotec expanded its sterile-pharmaceutical manufacturing facility in Glasgow, UK. The company doubled its capacity for the aseptic GMP manufacture of clinical trial material.

Regis Technologies. Regis Technologies (Morton Grove, IL), which offers chromatography services and custom-synthesis , recently expanded its development area to include an additional 7000 ft2 of synthetic laboratories and offices.

Asian players raise global profile

Just as Western companies invest in India, Indian CMOs are raising their position in the global outsourcing market.

Jubilant Organosys. In April 2007, Jubilant Organosys Ltd. (Noida, Uttar Pradesh, India) acquired Hollister-Stier Laboratories (Spokane, WA), a contract manufacturer of sterile injectables. The move strengthens Jubilant's contract research and manufacturing services (CRAMS) business and provides the company with another US-based manufacturing facility. Jubilant also has a solid-dosage form manufacturing facility in Salisbury, Maryland.

Jubilant provides CRAMS for advanced intermediates, fine chemicals, APIs, and dosage-forms as well as drug-discovery and development services. In 2007, the company booked orders of $60 million for its CRAMS business, up from $40 million in 2006.

In June 2007, Jubilant commissioned a new dosage-form FDA-compliant manufacturing facility at Roorkee, Uttarakhand, India. The facility has annual manufacturing capacity of 1.6–1.8 billion tablets and 150 million capsules.

Jubilant Organosys has manufacturing facilities in seven locations: Gajraula (Uttar Pradesh) for advanced intermediates and fine chemicals; Nanjangud (Karnataka) for API manufacturing; Roorkee (Uttarakhand) for dosage forms; Salisbury, Maryland, for solid-dosage forms; Spokane, Washington, for sterile injectables; and Nira, Maharashtra, and Samlaya, Gujarat, India. The company also is a large producer of pyridine and pyridine derivatives and recently increased production capacity of pyridine and picolines to 42,000 tons per year.

NPIL Pharma. NPIL Pharma (Mumbai, India) is continuing a $100-million investment program in formulation development and manufacturing services. The company 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 UK and India, and it plans a similar investment over 2007–2009. The investment includes a new sterile supplies pilot plant in Mumbai, India, which is scheduled to come on stream in the fourth quarter of 2007.

The company's focus on formulation services and final-dosage forms follows the addition of capabilities in this area from NPIL's 2006 acquisition of Pfizer, Inc. 's (New York) API and formulation manufacturing facility at Morpeth, UK. As result of the Morpeth acquisition, NPIL Pharma has annualized aggregate drug-formulation capacity of 3 billion tablets, 500 million low RH (<8%) tablets, 270 million hard-gelatin capsules, 180 million ophthalmic liquids, 48 million glass vials, and 30 million ampules.

In custom manufacturing, NPIL formed a new dedicated unit, NPIL Innovations or NPIL(i), to focus on developing and applying new technologies used in process development and production of APIs. The unit focuses on biocatalysis, chemocatalysis, and flow processing, including its catalyst-based racemization technology.

Dishman. In July, Dishman Pharmaceuticals and Chemicals (Ahmedabad, India) agreed to acquire Solvay Pharmaceuticals's (Brussels) fine-chemicals and vitamin businesses for an undisclosed sum. The deal includes Solvay's Veenendal, The Netherlands, facilities, as well as the intellectual property rights for fine chemicals, vitamin D, and vitamin D analogues.


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