Pharma/fine chemicals roundup—27 May 2014
12:40 AM MDT | May 27, 2014 | By DEEPTI RAMESH
FDA issues warning letter to Sun Pharma's API plant in India
FDA issued a warning letter on 7 May to the active pharmaceutical ingredient (API) and finished pharmaceutical manufacturing facilities of Sun Pharmaceutical Industries (Sun Pharma; Mumbai)—located at Karkhadi, Vadodara District, India—for violations of cGMP. The warning letter was published on the FDA Web site on 20 May. An FDA inspection from 13–16 November 2013 at the Karkhadi facility identified deviations from cGMP for the manufacture of APIs and the violation of cGMP regulations for finished pharmaceuticals, FDA says. An import alert was issued in March 2014 by the FDA against the Karkhadi facility. The FDA has conducted a detailed review of Sun Pharma's responses since the inspection, but it lacks sufficient corrective actions, FDA says.
SeQuent Scientific acquires pharmaceutical intermediates manufacturer in India
Pharmaceutical company SeQuent Scientific (Bangalore, India) informed the Bombay Stock Exchange (Mumbai) last week that it has entered into a definitive agreement to acquire the manufacturing assets and business of Arvee Syntthesis (Mysore, India). Financial details of the deal have not been disclosed. Arvee manufactures bulk drug intermediates and specialty chemicals. The Arvee manufacturing site will provide key intermediates to the human active pharmaceutical ingredient (API) business of SeQuent. Arvee's site has all the necessary regulatory approvals and infrastructure in place, as well as space for expansion, SeQuent says. "SeQuent's strategy of focusing on small, niche molecules is paying dividends. The human API business of SeQuent is poised to grow at a CAGR of over 50% in the medium term on the back of regulatory approvals for its key products in the regulated markets," says Manish Gupta, CEO of SeQuent.
Novasep completes expansion of HPAPI capacity in France
Novasep (Pompey, France), a supplier of services and technologies to the life sciences industry, says that it has completed a €4-million ($5.5 million) expansion of its highly potent active pharmaceutical ingredient (HPAPI) manufacturing capabilities at the company’s facility at Le Mans, France. The plant expansion has been fully qualified and is now being used to scale up validation of a commercial antibody-drug conjugate (ADC) payload, Novasep says.
Ranbaxy’s API business reports huge fall in sales
The active pharmaceutical ingredient (API) business of Ranbaxy Laboratories (Gurgaon, India) reports sales of 557 million Indian rupees ($9.4 million)for the January-March 2014 quarter, compared with sales of Rs1.81 billion in the year-ago period, mainly due to the suspension of API shipments from its plants at Toansa and Dewas, India, the company says. Earlier this year, Ranbaxy temporarily suspended shipping APIs produced at its plants at Toansa and Dewas, following an FDA announcement on 23 January prohibiting Ranbaxy from manufacturing and distributing APIs from its Toansa facility for FDA-regulated drug products. API shipments from the Toansa plant to the United States were suspended on 24 January. Ranbaxy voluntarily suspended all API shipments from the Toansa and Dewas plants to evaluate and inspect manufacturing processes and quality control systems.
Pfizer abandons AstraZeneca bid
Pfizer confirmed on 26 May that its “informal” offer to acquire AstraZeneca for £69.4 billion ($116 billion) had lapsed and that it was consequently withdrawing the offer. This follows the expiry of a 28-day “put up or shut up” deadline under UK takeover rules by which Pfizer was required to make a firm offer to AstraZeneca shareholders. Pfizer made an “informal” but “final” offer of £55/share in cash and Pfizer shares on 19 May for AstraZeneca, but that was rejected by the UK company’s board as substantially undervaluing the company’s long-term prospects.
Cambrex API manufacturing facility in Italy gets FDA approval
Cambrex (East Rutherford, NJ) announced last week that the US Food and Drug Administration (FDA) completed an inspection of Cambrex’s active pharmaceutical ingredient (API) manufacturing facility at Paullo, Italy. The inspection found the site to be compliant with the principles and guidelines of good manufacturing practice (GMP) and no Form 483 observations were issued, Cambrex says. The FDA authorities inspected the facility in December 2013. An FDA Form 483 is issued to a company at the end of an inspection when investigators have observed any conditions that in their judgement may constitute violations of FDA regulations. The entire facility and the quality systems used for the manufacture and release of APIs were subject to a detailed compliance inspection by the FDA, Cambrex says.
IFC lends $147.5 million to Jubilant
The International Finance Corporation (IFC; Washington), a member of the World Bank Group, is lending $147.5 million to Jubilant Pharma (Singapore), a wholly owned subsidiary of Jubilant Life Sciences (Noida, India), IFC says. The loan will help Jubilant Life Sciences increase focus on the pharmaceutical sector and strengthen its generic drug manufacturing facilities in India. Jubilant Life Sciences is a pharmaceutical and life sciences company engaged in the manufacture and supply of active pharmaceutical ingredients (APIs), generics, specialty pharmaceuticals, and life science ingredients. Jubilant Pharma has manufacturing operations in Canada, India, and the United States. “IFC’s contribution goes beyond financing. IFC will also help us strengthen our quality assurance and risk mitigation mechanisms and make the company systems more robust,” says Shyam Bhartia, chairman and managing director of Jubilant Life Sciences. “IFC’s long-term financing package will consolidate our entire pharmaceuticals business under Jubilant Pharma and build global competitiveness.”
Merck KGaA to expand biopharma site in Italy
Merck KGaA (Darmstadt, Germany) plans to invest €50 million ($68.5 million) at its production site at Bari, Italy to respond to rising demand for biopharmaceuticals. An additional production facility at Bari is to be commissioned in 2017, and it will perform the sterile filling and packaging of liquid drugs into syringes, vials, and ampoules, the company says.
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