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Pharma/Fine Chemicals Roundup – September 13
6:04 AM MDT | September 13, 2011 | By DEEPTI RAMESH
EFCG RATIFIES FDA'S PROPOSED GENERIC DRUG USER FEES ACT
The European Fine Chemicals Group (EFCG; Brussels) says its board has agreed to ratify the proposal of the U.S. Food and Drug Administration (FDA) to put forward a legislative package, designed with the help of EFCG and U.S. industry representatives, to deliver into U.S. law, a new generic drug user fees act (GDUFA). GDUFA requires the FDA to commit to significantly improve its regulatory activities for the benefit of global generic drug providers and U.S. generic drug users, in exchange for the global generics industry providing FDA with $299 million in user fees each year over the next 5 years.
The key benefits for drug providers will be faster and more predictable regulatory review times, including dealing with the backlog of applications, and parity of inspections between domestic and foreign sites for both active pharmaceutical ingredient (API) and finished dosage form manufacturers.
Generic drugs are those containing off-patent APIs. The EFCG was formed in 2004 as a sector group of the European Chemical Industry Council (Cefic) and represents fine chemical manufacturers in Europe, including those who make generic APIs.
“Regulators’ weak enforcement has made non-compliance a major competitive advantage. We congratulate FDA for leading the way to find solutions that both protect the patient and stop unfair competition,” says Guy Villax, CEO of Hovione and an EFCG board member.
LANXESS TO EXPAND THIONYL CHLORIDE CAPACITY IN INDIA
Lanxess says it will increase production capacity of thionyl chloride by 20% at its facility at Nagda, in the state of Madhya Pradesh, India, and the expansion will be completed in the second half of 2012. The project will involve a single-digit euro million investment, Lanxess says. Thionyl chloride is an important intermediate used for manufacturing fine chemicals, pharmaceuticals, agchems, and dyestuffs, Lanxess says.
“Indian demand [for thionyl chloride] has grown significantly by 8% in the recent years and we are expecting a continuation of consistent growth in the demand,” says Hubert Fink, head of advanced industrial intermediates business unit at Lanxess.
The operations at Nagda are part of the advanced industrial intermediates business unit, which is part of the Advanced Intermediates business segment of Lanxess, and the segment reported sales of about €1.3 billion in 2010.
ALBEMARLE TO INCREASE PRICES OF GENERIC APIS
Albemarle says it will increase global prices for generic active pharmaceutical ingredients (APIs) by 8%-12% depending on the specific product. The price increases will take effect starting October 15, 2011, or as contracts allow, Albemarle says. “The price increase will ensure that through a challenging economic environment, we are able to maintain the superior quality, regulatory status and services,” Albemarle says.
Albemarle's generic APIs are part of the company’s fine chemistry services (FCS) division in the Fine Chemistry global business unit. The FCS division makes and markets bulk and niche APIs for over-the-counter and prescription drugs, and provides custom manufacturing, R&D and other services to makers of pharmaceuticals, agricultural chemicals, specialty materials and other high-value markets.
BIOCON BUILDS BIOPHARMACEUTICAL FACILITY IN MALAYSIA
Biotechnology company Biocon (Bangalore, India) says it has begun construction of a biopharmaceutical manufacturing and research and development facility in Bio-XCell, a custom-built biotechnology park and ecosystem in Iskandar Malaysia, in the state of Johor, Malaysia. Biocon will invest about $161 million in the first phase of construction of the facility, which is expected to become operational in 2014. The project will also focus on research and development and production of other biopharmaceutical products at a later phase.