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Pharma/fine chemicals roundup—13 November
9:07 AM MST | November 13, 2012 | By DEEPTI RAMESH
EFCG says EU directive does not address API quality issues; calls for mandatory inspection of API manufacturing sites
The European Fine Chemicals Group (EFCG; Brussels), an industry association that is part of Cefic, says that thethe European Union's new Falsified Medicines Directive, which is designed to minimize counterfeit medicines entering the EU market, does not adequately address quality issues relating to active pharmaceutical ingredients (API) and does little to improve upon the present directive pertaining to patient safety. EFCG represents over 40 fine chemical manufacturers and trade bodies in the European Union that are involved in the global pharmaceutical supply chain.
EFCG says it is proposing a global harmonization of the rules and regulations governing the manufacture of APIs in order to level the worldwide playing field and to ensure the quality of APIs and medicines. This goal should be achieved through mandatory inspections of all global API manufacturers via a mutual recognition agreement approach and managed by the national regulatory authorities to share scarce inspection resources and to avoid the present duplication, EFCG says.
Orchid exits API jv in China
Orchid Chemicals & Pharmaceuticals (Chennai, India), a leading Indian pharmaceutical company, says it is exiting its 50-50 active pharmaceutical ingredient (API) manufacturing joint venture in China with North China Pharmaceutical Corp. (NCPC; Shijiazhuang, China), NCPC-Orchid Pharmaceuticals (Shijiazhuang). Orchid’s 50% stake in the jv will be transferred to NCPC for a total cash consideration of $13.9 million, Orchid says. Orchid and NCPC formed the jv in 2002 to establish a cephalosporin API manufacturing facility at Shijiazhuang.
“With the local Chinese players fast integrating, the operating conditions have become quite competitive in China,” says Raghavendra Rao, chairman and managing director of Orchid. “Moreover, the products that the jv manufactures and markets in the local Chinese market have reached a mature stage, resulting in flat growth prospects going forward. Hence, it was a prudent decision to relinquish our stake to the partner and exit the jv,” he says.
Ranbaxy’s API business reports fall in sales
The active pharmaceutical ingredient (API) business of Indian pharmaceutical major Ranbaxy Laboratories (Gurgaon, India) recorded sales of $32 million in the third quarter ended 30 September 2012, compared with sales of $35 million in the year-ago quarter. Profits for the API business were not disclosed. The company made 12 drug master file (DMF) submissions for APIs during the quarter, Ranbaxy says.
Ranbaxy reported a total net profit of $137 million in the third quarter of 2012 compared with a net loss of $103 million in the year-ago period. The company’s total sales increased to $480 million in the third quarter of 2012, from $442 million in the year-ago period.
Perrigo’s API business records fall in sales
The active pharmaceutical ingredient (API) business segment of Perrigo (Allegan, MI) recorded a 23.5% fall in sales in its fiscal first quarter, ended 29 September 2012, compared with the year-ago quarter, to $36.4 million. First-quarter operating profits for the API business decreased by 6.3%, to $13.3 million.
API sales declined primarily because of a decrease in existing product sales of about $17 million as a result of increased competition and pricing pressures on select products, along with a negative impact of $2 million due to unfavorable changes in foreign currency exchange rates, partially offset by $7 million related to the launch of a customer's product with 180-day exclusivity status, Perrigo says.
Lonza negotiates with unions to implement job cuts
Lonza says it has started negotiations with the unions Syna and Unia to implement the recently announced job cuts. Lonza on 31 October announced it will cut 500 jobs globally, including 400 positions at the company's production site at Visp, Switzerland. At least two-thirds of the job cuts will be achieved by internal transfers, natural attrition, early retirements, and a reduction of temporary work contracts, Lonza says. In two rounds of negotiations, the parties have agreed to approve a social plan by 23 November.
EU approves P&G's acquisition of Teva's over the counter business
The European Commission has cleared the proposed acquisition of the over-the-counter (OTC) business of generic pharmaceutical company Teva Pharmaceutical Industries (Petach Tikva, Israel) by Procter & Gamble (P&G). The Commission concluded that the transaction would not raise competition concerns because it would not significantly alter the market structure. Teva's initial OTC business was acquired by P&G in 2011. The present transaction concerns the OTC products that became part of Teva through its acquisition of Cephalon (Frazer, PA) in 2011, and are now being bought by P&G.