Pharma/fine chemicals roundup—24 June 2014
11:49 AM MDT | June 24, 2014 | By DEEPTI RAMESH
FDA issues warning letters to API plants in China and India
FDA issued separate warning letters earlier this month to the active pharmaceutical ingredient (API) manufacturing facilities of Tianjin Zhongan Pharmaceutical (Tianjin, China) and Apotex (Toronto) located at Tianjin; and Bangalore, India, respectively, for violating cGMP. The warning letters were published on the FDA Web site last week. FDA issued an import alert against the Bangalore facility in April. FDA has conducted a detailed review of Apotex's responses since the inspection, but the company lacks sufficient corrective actions, FDA says.
Merck Serono and Mersana to develop antibody-drug conjugates
Merck KGaA says that its biopharmaceutical division, Merck Serono (Darmstadt, Germany), has signed an agreement with Mersana Therapeutics (Cambridge, MA), to collaboratively develop next-generation antibody-drug conjugates (ADCs). ADCs are composed of an antibody linked to cytotoxic drugs, whereby the antibody part specifically targets and delivers the cytotoxic drug to cancer cells which could lead to higher drug levels at the tumor site. Mersana and Merck Serono will leverage Mersana’s Fleximer technology to generate ADCs for multiple undisclosed targets, and they have agreed to test a variety of ADCs by utilizing Mersana’s platform technologies and several cytotoxic agents as conjugates.
Abbott to acquire Russian pharma company Veropharm
Abbott (Abbott Park, IL) says it will acquire Veropharm (Moscow), a leading Russian pharmaceutical manufacturer. Abbott, under the terms of the agreement, will acquire Limited Liability Company Garden Hills, the holding company that currently owns a controlling interest in Veropharm, for between $395 million and $495 million. Garden Hills currently owns more than 80% of Veropharm but is expected to own more than 95% by the time the transaction closes. Abbott expects the acquisition to add about $150 million in sales in 2015. The transaction is expected to close in the fourth quarter. Veropharm has three manufacturing sites at Pokrov, Belgorod and Voronezh, and the company employs more than 2,000 people. Veropharm's product portfolio includes over 100 pharmaceutical products.
Granules India’s paracetamol API facility passes FDA inspection
Granules India (Hyderabad, India), a producer of active pharmaceutical ingredients (APIs), intermediates, and formulations, says that its paracetamol API facility at Bonthapally, India has passed a US FDA inspection without any inspection observations. The facility has the world's largest single API production line by volume, the company says.
Merck Millipore opens formulation lab in India
Merck Millipore, the life sciences tools division of Merck KGaA, on 18 June, opened a new process solutions formulation laboratory in India, its first outside Europe. The lab, which is part of a larger complex, is located at Navi Mumbai, within easy access to India's major pharma manufacturing centers at Ahmedabad, Goa, and Hyderabad. The facilities are designed to provide services and application assistance to the pharmaceutical industry for classical pharmaceutical clients working on solid-dose formulations. The objective is to assist clients, using advanced excipients from Merck Millipore portfolio, with preformulation studies.
Guilin Pharma's API gets WHO certification
Guilin Pharma (Shanghai), a member of the Fosun Pharmaceutical group (Shanghai), says that its artemether active pharmaceutical ingredient (API) has received product quality (PQ) certification by the World Health Organization (WHO), and the API has been included in WHO’s list of PQ-certified APIs for global buyers. The artemether API is Guilin Pharma’s first PQ-certified API.