Contract API Manufacturing: The Year in Review - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Contract API Manufacturing: The Year in Review
Expansion activity was limited as fine-chemical producers and CMOs of API and intermediates grapple with changing industry fundamentals.


Pharmaceutical Technology
pp. 36-40

A changing landscape

This year also saw some merger and acquisition (M&A) activity, primarily bolt-on acquisitions by select providers, some acquisitions by private-equity investors, reorganizations by other companies, and the emergence of new names in contract biopharmaceutical manufacturing.

Evonik Industries reorganized by combining its business in custom manufacturing of APIs (exclusive synthesis), pharmaceutical amino acids (the Rexim product line), and pharmaceutical polymers in a new healthcare business line, effective Sept. 1, 2011. The newly formed business line is part of the Health and Nutrition Business Unit. Earlier this year, Evonik increased its capacity by 50% to make pharmaceutical-grade glycine at its plant in Nanning, China.

Earlier this year, Johnson Matthey completed the integration of the biocatalyst offerings from X-Zyme, which the company acquired in July 2010. Johnson Matthey expanded the biocatalyst offerings into product and service offerings into its catalysis and chiral technologies business. The portfolio from X-Zyme includes enzymatic catalysts for scalable production of highly pure chiral amines and alcohols. The biocatalysts and related technology complement the chemocatalytic technology and related expertise of Johnson Matthey.

Granules India, a pharmaceutical manufacturer, and Ajinomoto OmniChem, a producer of fine chemicals, formed a joint-venture, Granules–OmniChem, to provide APIs and intermediates. Granules OmniChem is constructing a new facility in Vishakhapatnam (Vizag), Andhra Pradesh, India. The construction of the facility was scheduled to begin by November 2011 and is expected to be completed by late 2012 with production beginning by January 2013. The company will initially focus on high-value, low-volume APIs and intermediates for existing customers and will custom manufacture new chemical entities in the future.

CABB, a fine- and specialty-chemicals company, acquired the fine-chemicals company KemFine Group Oy through its Swiss subsidiary, for an undisclosed sum. In October 2011, Barclays Private Equity agreed to acquire CU Chemie Uetikon, a fine-chemical producer based in Lahr, Germany.

Carbogen Amcis restructured its Swiss operations in Bubendorf, Aarau, and Hunzenschwil. Under the restructuring plan, the Aarau site will focus more strongly on development and the Hunzenschwil site on the pilot production of early-phase projects. Large-volume production and the manufacturing of highly active agents will continue at the Bubendorf site. The company planned to reduce headcount by 60 employees.

On the biopharmaceutical front, earlier this year, Genzyme completed the sale of its pharmaceutical intermediates business to International Chemical Investors Group (ICIG). ICIG purchased substantially all of the pharmaceutical intermediates business, excluding the drug-delivery technologies portion. The acquired business was renamed Corden Pharma Switzerland and operates as part of ICIG's pharmaceutical business within the Corden Pharma group platform of companies. In September 2011, ICIG also acquired the former Boulder, Colorado, operations of Roche, which manufactures APIs, peptides, and small molecules. The operations are now named Corden Pharma Colorado.

Fujifilm Diosynth Biotechnologies, the former Merck Biomanufacturing Network, began operations under its new name following the completion of the acquisition of the Merck Biomanufacturing Network by Fujifilm in April 2011. Fujifilm Diosynth Biotechnologies provides contract biologics development and manufacturing services. The acquisition included facilities in Research Triangle Park, North Carolina, and Billingham, UK, manufacturing contracts, business-support operations, and a workforce.

In June 2011, Fujifilm and Mitsubishi formed a partnership for contract manufacturing for biopharmaceuticals. Under the partnership, the companies signed an agreement to transfer the ownership of 20% equity interests in Fujifilm's wholly owned biopharmaceutical contract manufacturing subsidiaries, Fujifilm Diosynth Biotechnologies U.S.A. and Fujifilm Diosynth Biotechnologies UK to Mitsubishi.

Also, in 2011, Johnson & Johnson acquired the biopharmaceutical and biomanufacturing firm, Crucell. Following the acquisition, Crucell operates as the center for vaccines within the Johnson & Johnson pharmaceuticals group.

Patricia Van Arnum is a senior editor at Pharmaceutical Technology, 485 Route One South, Bldg F, First Floor, Iselin, NJ 08830 tel. 732.346.3072,
.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
29%
Oversee medical treatment of patients in the US.
11%
Provide treatment for patients globally.
7%
All of the above.
46%
No government involvement in patient treatment or drug development.
7%
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
Source: Pharmaceutical Technology,
Click here