February 2, 2016 | By DEEPTI RAMESH
Feature Pharma ingredients: New therapies, faster approvals drive growth Business is picking up for the active pharmaceutical ingredients (APIs) industry, and the outlook for the pharma supply chain is positive for the next few years, according to industry association European Fine Chemicals Group (EFCG; Brussels). Major driving forces include higher demand for products with greater added value, the return...
January 26, 2016 | By DEEPTI RAMESH
Johnson Matthey expands UK R&D facilities Johnson Matthey says it has expanded the R&D facilities at its Cambridge, UK, location. Additional capacity has been added in process R&D and in non-GMP production on a kilogram scale of materials for pre-clinical pharmaceutical and toxicology studies, the company says. The expansion includes 20 fume cupboards, two laboratories with capacity up to 100...
January 19, 2016 | By DEEPTI RAMESH
FDA issues warning letter to Hisun’s API plant in China The US FDA issued a warning letter on 31 December 2015 to the active pharmaceutical ingredient (API) manufacturing facility of Zhejiang Hisun Pharmaceutical—located at Taizhou, China—for violating cGMP. The warning letter was published on the FDA Web site on 12 January 2016. An FDA inspection from 2–7 March 2015 at the facility...
January 12, 2016 | By DEEPTI RAMESH
SAFC’s Gilles Cottier joins Patheon as head of pharmaceutical development services Patheon (Durham, NC), a provider of outsourced pharmaceutical development and manufacturing services, says that it has appointed Gilles Cottier as president of the company’s pharmaceutical development services (PDS) division, effective immediately. He will serve as a member of Patheon’s executive committee...
January 5, 2016 | By DEEPTI RAMESH
FDA issues warning letter to Cadila's API plant in India Pharmaceutical company Cadila Healthcare (Ahmedabad, India) informed the Bombay Stock Exchange (Mumbai) on 31 December 2015 that it has received a warning letter from the US FDA relating to the company’s active pharmaceutical ingredient (API) manufacturing facility at Ahmedabad, and its formulations facility at Moraiya, India, for violations of...
December 29, 2015 | By DEEPTI RAMESH
PCI Synthesis: US manufacturers to become more competitive as Chinese wages increase PCI Synthesis (Newburyport, MA), a manufacturer of new chemical entities (NCEs), generic active pharmaceutical ingredients (APIs), and other specialty chemical products, has outlined the trends that are likely to impact the generic drug industry in 2016: the US FDA will make progress on its backlog but approval for...
December 22, 2015 | By DEEPTI RAMESH
AMRI acquires Whitehouse Laboratories Albany Molecular Research Inc. (AMRI; Albany, NY) says that it has acquired Whitehouse Laboratories (Lebanon, NJ), a provider of testing services that includes chemical and material analysis, method development and validation and quality control verification services to the pharmaceutical, medical device and personal care industries. The purchase price is $54 million...
December 21, 2015 | By ROB WESTERVELT
The combination of Dow Chemical and DuPont, announced 11 December, brings together two American corporate icons that have driven and helped define much of the global chemical industry’s development for more than 100 years....
December 15, 2015 | By DEEPTI RAMESH
FDA warns of contamination of baclofen API from Taizhou Xinyou Pharmaceutical The US FDA, on 9 December, alerted drug manufacturers in the United States that certain lots of baclofen active pharmaceutical ingredient (API) manufactured by Taizhou Xinyou Pharmaceutical & Chemical (Taizhou, China), may be at risk for contamination with particulates and should not be used to compound sterile injectable...
December 8, 2015 | By DEEPTI RAMESH
Dottikon reports rise in sales, swings to profit Fine chemicals company Dottikon Exclusive Synthesis (Dottikon ES; Dottikon, Switzerland) reports sales of 43.20 million Swiss francs ($43.29 million) for the fiscal first half ended 30 September 2015, an increase of 10.5% over the first half of the previous fiscal year. Dottikon ES reports a net profit of SF1.0 million for the fiscal first half, compared...
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