Pharma/fine chemicals roundup—26 March 2014
3:55 AM MDT | March 26, 2014 | By DEEPTI RAMESH
AMRI to acquire API firm Cedarburg
Albany Molecular Research Inc. (AMRI; Albany, NY) says that it has signed a definitive agreement to acquire all the outstanding shares of Cedarburg Hauser Pharmaceuticals (Grafton, WI), for $38.2 million in cash. The transaction, including $2.8 million of assumed liabilities, is valued at $41 million. Cedarburg is a contract developer and manufacturer of technically complex active pharmaceutical ingredients (APIs) for both generic and branded customers. The transaction is expected to close in early April. Cedarburg's forecasted full year 2014 revenue is about $19 million, with adjusted Ebitda between $5.5 million and $5.7 million, AMRI says.
FDA issues warning letter to Smruthi Organics’ API plant in India
FDA issued a warning letter earlier this month to the active pharmaceutical ingredient (API) manufacturing facility of Smruthi Organics (Solapur, India) located at Solapur, for violations of cGMP. An FDA inspection from 15-18 October 2013 at the Solapur facility identified deviations from cGMP for the manufacture of APIs, FDA says. The warning letter was published in the FDA website earlier this week. The FDA has conducted a detailed review of Smruthi Organics' 4 November 2013 response, but it lacks sufficient corrective actions, FDA says. The violations at the API site include failure to maintain complete and accurate laboratory test data generated in the course of establishing compliance of the company's APIs to established specifications and standards; failure to maintain and make available for inspectional review production and control records for currently marketed APIs; and inadequate investigations of critical deviations or a failure of a batch to meet its specifications or quality standards, FDA says.
Evonik gets Excipact certification as excipient supplier
Excipact says that Evonik Industries has received an Excipact certification from mdc (Stuttgart, Germany), one of Excipact's certification bodies. The Excipact certification demonstrates that the Evonik site at Darmstadt, Germany manufactures pharmaceutical excipients according to Excipact GMP certification standards.
This is the fifth German site to receive such certification, and there are other certified sites in Canada, France, the Netherlands, and Saudi Arabia — a BASF site at Ludwigshafen; Merck KGaA site at Darmstadt; Aug. Hedinger site at Stuttgart; a Biogrund site at Hunstetten, Germany; a Sonneborn Refined Products site at Amsterdam; a Sepiprod site at Castres, France; an A&C American Chemicals site at Montreal; and a Saudi Kayan site at Al Jubail, Saudi Arabia. Excipact, which was a project of the IPEC Federation (Brussels), became a free-standing, not-for-profit company at the end of January 2014.
AstraZeneca completes acquisition of Sumitomo's stake in AstraZeneca’s Japanese unit
AstraZeneca announced today that it has completed the purchase of Sumitomo Chemical’s remaining shares in AstraZeneca K.K. (Osaka). Sumitomo announced last month that it planned to sell its 20% stake in AstraZeneca K.K. The purchase was valued at approximately ¥10 billion ($102 million) and gives AstraZeneca full control of AstraZeneca K.K. “Our decision to gain full control of AstraZeneca K.K. reinforces our focus on Japan as a key growth platform,” said Marc Dunoyer, CEO of AstraZeneca.
Dow Corning appoints PolyOne as distributor for medical-grade silicone products in China
Dow Corning says it has appointed PolyOne Distribution as its distributor for medical-grade silicone products in Greater China. Both companies see strong potential in the Greater China region for growing their respective businesses and meeting customer and patient needs in drug delivery, medical devices and pharmaceutical and biopharmaceutical processing, Dow Corning says. The addition of Dow Corning brand silicones to the PolyOne Distribution portfolio broadens the ability of both companies to support health care customers in China. PolyOne will offer a single channel for thermoplastic and thermoset resins used in medical applications.
Grace introduces purification solution to lower cost, accelerate drug development for biologics
W. R. Grace says it has introduced ProVance pre-packed columns, a portfolio of products for cost-effective purification of biologic drugs, specifically monoclonal antibodies (mAbs). Monoclonal antibodies are key therapeutic agents used to treat rheumatoid arthritis, cancer and other diseases. In the United States, mAbs currently constitute the single largest biologics product category in the clinical development pipeline; purification of these agents is a critical step in drug development, Grace says.The ProVance portfolio of disposable columns come pre-packed with a new silica resin that has a higher capacity and lower cost than the leading alternative technology used for mAb purification, Grace says.
“Increasingly, biotech companies have been adopting disposable manufacturing solutions in the early stages of the drug development process to reduce development time and capital investments. Until now, the purification technologies used in the downstream portion of the multi-step drug development process have not kept pace,” says Adam Grose, v.p. and general manager of Grace Discovery Sciences. “Leveraging Grace’s silica purification expertise and material science capabilities, the ProVance portfolio of products now brings the flexibility and cost-effectiveness of single use manufacturing to the purification process, allowing companies to realize the benefits of an end-to-end disposable solution.”
Beyond IHS Chemical Week:
US FDA looks to increase domestic, foreign drug manufacturer inspections
The number of foreign inspections by the US FDA is expected to grow at a faster rate in FY 2015 than the increase in domestic inspections. The inspection numbers were detailed in the HHS budget request for 2015, which notes that overseas inspections are expected to rise from 827 to 999, while domestic facility inspections is only going to rise from 1851 to 1856.
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