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Pharma/Fine Chemicals Roundup – 16 October
8:02 AM MDT | October 16, 2012 | By DEEPTI RAMESH
Saltigo shuts US site
Saltigo (Langenfeld, Germany), a Lanxess subsidiary, says it has discontinued production at the company’s Redmond, WA, site and that it has abandoned a previously announced plan to produce potent active pharmaceutical ingredients at that site. “We have decided to focus more on launched products or products in Phase III clinical trials and the Redmond site was involved in products required during phases I and II. So we have decided not to continue our activities in the US,” Wolfgang Schmitz, CEO of Saltigo, told CW at the CPhI trade fair at Madrid. Saltigo closed the Redmond site in July 2012, and this led to 20 job losses, the company says.
Dr. Reddy’s builds large-scale API facility in India
Dr. Reddy’s Laboratories (Hyderabad, India), the second-largest API company in the world in terms of sales, after Teva, says that it will open a new large-scale active pharmaceutical ingredient (API) manufacturing facility at Visakhapatnam, India, later this year. The current global API manufacturing operations of Dr. Reddy’s include six plants in India; one plant at Mirfield, UK; and a plant at Cuernavaca, Mexico. All the facilities are approved by the US FDA. “As we grow, we need production capacity to support this growth. Later this year, we will be commissioning a large-scale API facility in a special economic zone at Visakhapatnam,” R. Ananthanarayanan, president, pharmaceutical services and active ingredients business of Dr. Reddy’s told CW at the CPhI trade fair at Madrid last week. “The facility will begin production of validation batches by the end of this year. This new 300-acre production site will be a key site for us, and it allows for future expansions,” Ananthanarayanan says.
Aesica to triple API sales in three years
Aesica Pharmaceuticals (Newcastle, UK), a provider of active pharmaceutical ingredients (APIs), formulations, and custom synthesis, says that it plans to triple annual revenues from the company’s API business by 2015. Aesica recorded total sales of about $250 million in 2011 and the company’s API business has annual sales of about $50 million. “We have a focused plan to increase the annual API revenues to at least $150 million by the end of 2015, and this will be through a mix of organic and inorganic growth,” Kevin Cook, managing director/API business unit at Aesica, told CW at the CPhI trade fair at Madrid.
DSM Sinochem Pharmaceuticals to build Atorvastatin facility in India
DSM Sinochem Pharmaceuticals (DSP; Singapore), the former DSM Anti-Infectives business, says that it is planning to build production capacity for manufacturing the active pharmaceutical ingredient (API) for atorvastatin, the generic version of cholesterol-lowering drug Lipitor, at DSP’s existing production facility at Toansa, India. Pfizer’s Lipitor has been the top-selling drug worldwide. DSP says it is also considering manufacturing the finished dosage form of atorvastatin. “[Atorvastatin] will be an important business for the company, and several millions will be invested in this business in the near term,” Karl Rotthier, COO of DSP, told CW at the CPhI trade fair at Madrid last week. “We may work with a contract manufacturing organization (CMO) for the finished dosage form project, but we are exploring the possibility of establishing a new finished-dosage form manufacturing plant in the near future,” Rotthier says. Commercial production of atorvastatin at Toansa will begin in 2015, he says.
Codexis focuses on innovator companies
Codexis (Redwood City, CA), a company that develops industrial enzymes to enable the production of pharmaceuticals, biofuels, and biobased chemicals, says that it continues to concentrate more on innovator companies for growth of its pharmaceutical business, the unit being key for its new management, which is focused on improving its bottom line.
Drug product manufacturing business to drive growth for Hovione
Active pharmaceutical ingredients (API) manufacturer Hovione (Loures, Portugal) says that it expects the drug product business to be the growth driver for Hovione post-2015, and that this is a significant change for the company. “I think that a lot of the growth that Hovione will enjoy during the second half of this decade will be around the drug product manufacturing business, because it is an area where you need much more sophisticated science and where you have more demanding regulators,” Guy Villax, CEO of Hovione, told CW on the sidelines of a press conference at the CPhI trade fair at Madrid. “I think the area of APIs is being highly commoditized, and it does not seem to be an area of high growth. You may have large volumes in the [API] business, but the value in the business is decreasing,” he says.
EFCG: FDA did well to implement GDUFA but disappoints with FMD
The US FDA did a good job of implementing the Generic Drug User Fee Act (GDUFA), but has disappointed as far as the European Union's (EU) falsified medicines directive (FMD) is concerned, Guy Villax, CEO of API maker Hovione (Loures, Portugal) and board member of the European Fine Chemicals Group (EFCG), said at a press conference today at the CPhI trade fair at Madrid. The GDUFA became effective on 1 October 2012. The GDUFA will help increase inspections of US and overseas manufacturers of APIs and finished pharmaceuticals. The global generic drug industry will pay the US FDA a total of about $1.5 billion over 5 years in return for faster and more predictable reviews of generic drug applications, according to the terms of GDUFA.
Novasep to build world’s largest chromatography plant in France
Novasep (Pompey, France) says it will invest €30 million ($39 million) to build the world’s largest chromatography plant for the pharmaceutical industry at the company’s existing site at Mourenx, France. The plant will be used for the production of a large-volume, commercial active pharmaceutical ingredient (API).
US FDA approves generic drug containing Lubrizol's polymer
Lubrizol says that the US FDA has recently approved a generic drug product containing Lubrizol's carbomer homopolymer type A, sold under the trade name Carbopol 971P, as a tablet ingredient. “Carbopol 971P NF Polymer is a very efficient excipient material used to control the release of the active pharmaceutical ingredient over time in pharmaceutical formulations. Carbopol has already been approved in other drug applications. The approval of this generic drug product will allow our customers to formulate using a much higher level of Carbopol, broadening the functionality and benefits to the end user,” says Deb Langer, general manager of Lubrizol's lifescience polymers business.
IK Investment Partners to acquire Vemedia Pharma
Private equity firm IK Investment Partners (London) has agreed to acquire a majority stake in Vemedia Pharma (Kortrijk, Belgium), one of Europe’s leading suppliers and distributors of over the counter medicines in the specialist areas of sleeping and calming products and vitamins. IK Investment Partners also intends to launch a voluntary and conditional bid on the remaining shares of Vemedia.