Pharma/fine chemicals roundup—11 March 2014
7:53 AM MDT | March 11, 2014 | By DEEPTI RAMESH
API producer ScinoPharm reports rise in profits and sales
Active pharmaceutical ingredients (APIs) manufacturer ScinoPharm (Tainan, Taiwan) reports a 9% increase in net profits for the full year 2013, compared with 2012, to 1.27 billion New Taiwan dollars ($42 million). Full-year 2013 sales increased 11%, to NT$5.08 billion. APIs for oncological and central nervous system (CNS) treatments have achieved steady sales, ScinoPharm says. Sales of irinotecan, used for the treatment of colorectal cancer, have nearly tripled in 2013 compared to 2012, making it the product bringing in most revenue for the company. ScinoPharm has developed nearly 70 products, 23 of which have been launched in the market. In 2014, seven additional API products are expected to be launched in Canada, Europe, Japan, and the United States.
A&C American Chemicals and Biogrund get Excipact certification as excipient suppliers
Excipact says that Biogrund (Hunstetten, Germany) and A&C American Chemicals (Montreal) have separately received an Excipact certification from DQS (Frankfurt) and SGS, respectively. DQS and SGS are Excipact's certification bodies. The Excipact certification demonstrates that the Biogrund and A&C American Chemicals sites manufacture pharmaceutical excipients according to Excipact GMP and good distribution practice (GDP) certification standards.
This is the fourth German site and the first North American site to receive such certification. The other certified sites are in France, the Netherlands, and Saudi Arabia —a BASF site at Ludwigshafen; Merck KGaA site at Darmstadt; Aug. Hedinger site at Stuttgart, Germany; a Sonneborn Refined Products site at Amsterdam; a Sepiprod site at Castres, France; and a Saudi Kayan site at Al Jubail, Saudi Arabia—Excipact says. Excipact, which was a project of the IPEC Federation (Brussels), became a free-standing, not-for-profit company at the end of January 2014.
Amneal and Intrexon collaborate for API production
Generic drug manufacturer Amneal Pharmaceuticals (Bridgewater, NJ) and biotech company Intrexon (Germantown, MD) say that they have entered into a collaboration to develop an improved production process for a complex active pharmaceutical ingredient (API). The vast majority of APIs are currently produced through a series of complex chemical processes. The goal of the collaboration is to develop a biological process for a targeted API product that may reduce the cost of production. The collaboration will leverage Intrexon's proprietary UltraVector platform as well as the company's suite of integrated synthetic biology technologies. “Amneal is a leader in generic pharmaceuticals. [The company's] experience combined with Intrexon's synthetic biology technology has the potential to drive a complex, multistep chemical process toward a new era of more affordable drugs produced through biology-enabled production methods,” says Samuel Broder, chairman/health at Intrexon.
PolyOne launches technology to serve health-care industry
PolyOne says it has launched NEU View Radiopaque Translucent Solutions, a polymer formulation that provides catheter manufacturers and health-care professionals enhanced material functionality and performance. Catheters made using the patent-pending NEU View technology provide optical visibility when outside the body and superior visibility under X-ray when inside the body, PolyOne says. This solution provides significant advantages when compared with existing striped radiopaque catheters, which offer less X-ray visibility and may require multiple manufacturing steps and materials to produce, PolyOne says. “Our health-care solutions portfolio continues to grow, as does our mix in this important industry, where last year company revenues from health care reached $413 million as compared to $103 million in 2006,” says Robert Patterson, executive v.p. and COO at PolyOne.
Beyond IHS Chemical Week:
FDA warns India on drugs standards
from the Financial Times, UK
America’s top drugs watchdog has urged New Delhi to work with US regulators to help raise standards in the Indian pharmaceuticals industry, amid mounting scrutiny of the country’s role in the global drugs supply chain. Margaret Hamburg, commissioner of the Food and Drug Administration, urged her Indian counterparts to “come to the table” and co-operate on efforts to stamp out substandard and fake medicines after lapses in quality at Indian plants. “It’s not good for them, it’s not good for the Indian pharmaceutical industry and, above all, it’s not good for patients if [Indian regulators] are not participating,” Ms Hamburg told the Financial Times, adding that they “need to step up their game”.
India has been dubbed “pharmacy to the world” because of its share of the global market for cheap generic drugs, including 40 per cent of all over-the-counter medicines sold in the US.
But as the US becomes more dependent on drugs from the sub-continent, regulators in Washington are looking harder at quality standards.
Lupin to expand API facility
from the Business Standard, India
Mumbai-based pharma player Lupin is all set to expand its Vadodara, India facility to make bulk drugs for cardiac, anti-infectives, anti-tuberculosis, neurology and other segments. The Dabhasa plant of Lupin near Vadodara is one of the leading bulk drug [active pharmaceutical ingredient] manufacturing sites for the company. The company is planning to expand the unit to add more bulk drugs belonging to the categories of anti-cholesterol, cardiac, neuropathic, respiratory, anti-infectives among others. The company is a leading global manufacturer of anti-tuberculosis bulk drugs.