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Pharma/fine chemicals roundup—8 April 2014

12:08 AM MDT | April 8, 2014 | By DEEPTI RAMESH

FDA issues warning letter to GlaxoSmithKline’s API plant in Ireland

The US FDA issued a warning letter on 18 March to the active pharmaceutical ingredient (API) manufacturing facility of GlaxoSmithKline (GSK; London) located at Carrigaline in the county of Cork, Ireland, for violations of cGMP. An FDA inspection from 18–23 October 2013 at the Carrigaline facility identified deviations from cGMP for the manufacture of APIs, FDA says. The warning letter was published in the FDA web site on 1 April. The FDA has conducted a detailed review of GSK's response, but it lacks sufficient corrective actions, FDA says.
The violations at the API site include failure to fully investigate critical deviations; failure to investigate and document out-of-specification results; and failure to demonstrate that the company's manufacturing process can reproducibly manufacture an API meeting its predetermined quality attributes, FDA says.

Sun Pharma to acquire Ranbaxy for $3.2 billion

Sun Pharmaceutical Industries (Mumbai) says it has agreed to acquire 100% of Ranbaxy Laboratories (Gurgaon, India) in an all-stock transaction, which has a total equity value of about $3.2 billion. The combination of Sun Pharma and Ranbaxy will create the fifth-largest specialty generics company in the world and the largest pharmaceutical company in India. Ranbaxy shareholders, under the agreement, will receive 0.8 share of Sun Pharma for each share of Ranbaxy. The proposed acquisition has been approved by the boards of directors of Sun Pharma and Ranbaxy as well as Ranbaxy’s controlling shareholder, Daiichi Sankyo (Tokyo). Sun Pharma expects the transaction to close by the end of 2014. Upon closing, Daiichi Sankyo will become a significant shareholder of Sun Pharma and will have the right to nominate one director to Sun Pharma’s board.
The combined entity will have operations in 65 countries, 47 manufacturing facilities across five continents, and a significant platform of specialty and generic products marketed globally. On a pro forma basis, the combined entity’s annual revenues are estimated at $4.2 billion, Sun Pharma says.

AMRI completes acquisition of API firm Cedarburg

Albany Molecular Research Inc. (AMRI; Albany, NY) says that it has completed the previously announced acquisition of Cedarburg Hauser Pharmaceuticals (Grafton, WI). Total consideration that's been paid is $41 million, including assumption of certain liabilities. AMRI financed the transaction with cash on hand. Cedarburg is a contract developer and manufacturer of technically complex active pharmaceutical ingredients (APIs) for both generic and branded customers. Cedarburg's revenue forecast for full-year 2014 is about $19 million, AMRI says. The acquisition is expected to add $13–14 million to AMRI’s revenue in 2014.

Ashland opens pharmaceutical research center in India

Ashland's specialty ingredients commercial unit, on 7 April, opened a new pharmaceutical center of excellence at Hyderabad, India. The Hyderabad facility specializes in oral, solid-dosage form research and expands Ashland’s global reach, pharmaceutical research, and footprint outside of North America, the company says.
“Research and development dedicated to optimal yields and lower variability in oral, solid-dosage forms is essential to the future success of the pharmaceutical manufacturing industry,” says Jim Mish, group v.p./consumer specialties, specialty ingredients at Ashland. “Emerging manufacturing processes, such as continuous manufacturing by spray drying or hot melt extrusion, is one component of this equation; excipients science is another. At our new center of excellence, we bring together our expertise in process technology and our knowledge in materials science to further support the quality, safety, and efficiency of oral, solid-dosage forms,” Mish says.

Evonik completes expansion of service lab for pharmaceutical polymers in China

Evonik has expanded its technical service laboratory for pharmaceutical polymers in Shanghai in response to the dynamic growth of China's pharmaceutical market, the company says. The laboratory is at the Xinzhuang Industry Park. The facility serves as a technical service laboratory and a center of excellence for contract development of oral drug-delivery systems. Customers, with the help of Evonik experts, can simulate the actual manufacturing process in the service laboratory and evaluate how coating, tableting, or granulation works.

Actavis completes sale of operations in seven European countries to Aurobindo; buys Thai generics company Silom

Actavis (Dublin) says that it has completed the previously announced divestiture of its generics commercial operations in seven markets in Western Europe to Aurobindo Pharma (Hyderabad, India), a manufacturer of generic pharmaceuticals and active pharmaceutical ingredients. The agreement to divest the operations was announced in January. Aurobindo acquired Actavis' pharmaceutical commercial infrastructure in Belgium, France, Germany, Italy, the Netherlands, Portugal, and Spain, including products, marketing authorizations, and dossier license rights. The two companies also entered into a long-term strategic supply arrangement.
Separately, Actavis announced that it has acquired Silom Medical (Bangkok), a privately held generic pharmaceutical company, for about $100 million in cash. The acquisition of Silom Medical immediately elevates Actavis into a top-five position in the Thai generic pharmaceutical market, Actavis says.

Beyond IHS Chemical Week:

US FDA issues import alert on Apotex’s Indian API facility
from in-PharmaTechnologist.com

The US FDA has banned generic drug maker Apotex from importing drugs made at its plant in Bangalore, India after discovering GMP violations.












 
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