Pharma/fine chemicals roundup—5 August 2014
4:08 AM MDT | August 5, 2014 | By DEEPTI RAMESH
FDA issues warning letter to API producer in China
The US FDA issued a warning letter on 9 July to the active pharmaceutical ingredient (API) manufacturing facility of Zhejiang Jiuzhou Pharmaceutical and its export subsidiary, Zhejiang Zonebanner Jiuzhou Imp. & Exp. Co., which are both located at Taizhou, China, for violations of cGMP and misbranding. An FDA inspection from 21–24 October 2013 at the Taizhou facility identified deviations from cGMP for the manufacture of APIs, FDA says. The warning letter was published in the FDA web site on 29 July. In addition to violating cGMP, the company also shipped a misbranded API to the United States, FDA says.
Cambrex reports huge rise in profits
Cambrex (East Rutherford, NJ) reports a more than eightfold increase in net profits for the second quarter of 2014 compared with the second quarter of 2013, to $19.66 million. Second-quarter sales increased 58.1%, to $97.34 million. The company recorded sales increases in all of its product categories, with strong growth in certain branded active pharmaceutical ingredients (APIs), controlled substances, and generic APIs, Cambrex says. “I am extremely pleased with our strong second-quarter and first-half financial results and look forward to an even stronger second half of the year,” says Steven Klosk, president and CEO of Cambrex. “Our recent and ongoing investments in both capital improvements and personnel have allowed us to significantly increase our volumes. During the first half of the year, we also made significant progress in strengthening relationships with certain key customers, winning strategic supplier status with a large pharmaceutical customer and putting Cambrex in a position to win future projects with another. We are also pleased to have purchased the remaining shares in Zenara Pharma during the second quarter. While it will take some time, we believe Zenara's capabilities will complement our strong position in the API market,” Klosk says.
Codexis appoints new CFO
Codexis (Redwood City, CA), a developer of biocatalysts for the pharmaceutical and fine chemical industries, says that Gordon Sangster has agreed to join Codexis as senior v.p. and CFO. Sangster will succeed David O’Toole, who resigned on 3 July. Sangster, who will start on 18 August, will manage all aspects of Codexis's financial and accounting functions and will report to John Nicols, president and CEO.
Sangster has served as CFO at multiple public and private life science companies for the last 14 years, Codexis says. From October 2011–July 2014, Sangster served as CFO of Nitinol Devices & Components (Fremont, CA), a private medical device manufacturer.
API business of Dr. Reddy’s reports fall in sales
The pharmaceutical services and active ingredients (PSAI) business of Dr. Reddy’s Laboratories (Hyderabad, India) reports a 5.6% fall in sales in the company’s fiscal first quarter, ended 30 June, compared with the year-ago quarter, to 5.53 billion Indian rupees ($92 million). Earnings figures for the PSAI business have not been disclosed.
FDA okays Hovione’s API plant in Ireland following inspection
Hovione (Loures, Portugal) says that its active pharmaceutical ingredient (API) manufacturing plant at Cork, Ireland has passed a pre-approval inspection by the US Food and Drug Administration (FDA). The inspection from 21-25 July confirmed the site to be compliant with the principles and guidelines of GMP and no Form 483 observations were issued, Hovione says. “The pre-approval inspection was triggered by a client NDA [new drug application] filing, it also covered the manufacturing of a commercial NDA and a generic antibiotic, doxycycline,” says Luisa Paulo, compliance director at Hovione.