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Pharma/fine chemicals roundup—9 July 2013
10:59 AM MDT | July 9, 2013 | By DEEPTI RAMESH
Saltigo signs contract manufacturing deal with Daiichi Sankyo
Saltigo (Langenfeld, Germany), a wholly owned subsidiary of Lanxess, says it has signed an agreement with Daiichi Sankyo (Tokyo), one of the world's leading pharmaceutical companies, for providing contract manufacturing services. The agreement is associated with the preparation for commercializing one of Daiichi Sankyo’s novel drug pipeline projects, Saltigo says.
FDA issues warning letter to Fresenius API plant in India
Health-care group Fresenius (Bad Homburg, Germany) says that its Fresenius Kabi (Pune, India) subsidiary has received a warning letter, dated 1 July, from the US FDA related to an inspection of Fresenius Kabi’s oncolytic active pharmaceutical ingredient (API) plant at Kalyani, India, in January 2013. The warning letter is related to GMP nonconformities regarding manufacturing, documentation practices, and data integrity, Fresenius says. Many of the data integrity items cited in the warning letter were self-identified by Fresenius Kabi postinspection and shared with the FDA, Fresenius says. The company has made significant progress in remedying the issues cited in the warning letter. Based on a detailed remediation action plan submitted to the FDA, Fresenius Kabi has begun the process of restarting manufacture at the facility, Fresenius says.
Hikal signs long-term supply contract with new pharma customer
Hikal (Mumbai), the outsourcing firm serving pharmaceutical and agricultural chemical companies, says it has signed a long-term supply agreement with a global biopharmaceutical company to produce and supply products from Hikal’s pharmaceutical division, which offers intermediates and active ingredients. The undisclosed customer is a leading innovator company, which serves markets globally for human health treatments.
Aesica to create lead technical centers for API development
Aesica Pharmaceuticals (Newcastle, UK), says it has appointed Bashir Hansraj as global technical director, and he will be responsible for developing lead technical centers across the entire international Aesica network from active pharmaceutical ingredient (API) and drug product development sites right through to finished product manufacturing and packaging. Hansraj will lead and direct the company’s global technical and innovation strategy across the full spectrum of API and dosage-form development. Technical centers will be dedicated to specific dosage forms including oral solids, oral liquids, topicals, inhalation, and parenterals. “The creation of lead technical centers will enhance the technical expertise and services we will offer to our customers. We aim to provide creative solutions for the challenges of drug life-cycle management throughout the continuum of preclinical development through to post patent expiration,” Hansraj says.
Caldic establishes subsidiary in India
Distributor Caldic (Rotterdam) says it is continuing its growth in the emerging markets through the creation of Caldic India (Mumbai). Caldic India will focus on chemical as well as food distribution and will operate as a full service distributor for mainly the pharmaceutical, chemical, and food markets. “Caldic looks at India as an important and strategic growth market and it is with this belief that we have decided to have a direct presence with the establishment of Caldic India, headquartered in Mumbai, the commercial capital and chemical hub of India,” says O.C. van Caldenborgh, Caldic board member.
Beyond IHS Chemical Week:
Chinese API plant oversight improving, but careful sourcing is key says EMA
Chinese oversight of API plants is improving, but it is still important EU importers choose their sources carefully says European Medicines Agency collaboration chief, Emer Cooke.
Local API base key to pharma future
from Dhaka Tribune, Bangladesh
Despite having achieved remarkable success in the manufacturing, marketing and exporting of finished pharmaceutical products, Bangladesh still has a long way to go in the production of its raw materials. Even though Bangladesh currently has a 90-billion taka pharmaceutical market, 90% of the raw materials have to be imported from abroad. The local companies are hardly interested in producing raw materials because the cost of producing locally is much higher than the cost of importing them.