IHS Chemical Week


Pharma/fine chemicals roundup—27 August 2013

12:06 AM MDT | August 27, 2013 | By DEEPTI RAMESH

Siegfried reports increase in profits and revenue, sees positive trend in second half

Siegfried (Zofingen, Switzerland), a producer of active pharmaceutical ingredients (APIs), pharma intermediates, and finished dosage form products, reports a significant rise in sales and profits in the first six months of 2013. Net profit was up 41%, at 18.5 million Swiss francs ($20.1 million), on sales 10% higher, at SF196.7 million. Ebitda was 31% higher, at SF27.9 million, corresponding to a margin of 14.2% compared with 11.9% achieved in the year-earlier period. Ebit rose 72%, to SF15.6 million.

Amgen to acquire Onyx Pharmaceuticals for $10.4 billion

Amgen (Thousand Oaks, CA), the world’s largest independent biotechnology company; and Onyx Pharmaceuticals announced on Sunday that their boards of directors have unanimously approved a transaction for Amgen to acquire all of the outstanding shares of Onyx for $125/share in cash. The purchase price is $10.4 billion, or $9.7 billion net of estimated Onyx cash.

FDA issues warning letter to API plant in India

FDA issued a warning letter earlier this month to the active pharmaceutical ingredient (API) manufacturing facility of Posh Chemicals (Hyderabad, India) located at Hyderabad for violations of cGMP. An FDA inspection from 3-8 March 2013 at the Hyderabad API facility identified significant deviations from cGMP for the manufacture of APIs, FDA says.  The violations for at the API site include failure to protect computerized data from unauthorized access or changes; failure to ensure that test procedures are scientifically sound and appropriate to ensure that key starting materials and intermediates conform to established standards of quality and/or purity; and failure to follow and document quality-related activities at the time they are performed, FDA says.
FDA says in the warning letter to Posh Chemicals that it “may withhold approval of any new applications or supplements listing your firm as an API manufacturer, until all corrections have been completed and FDA has confirmed corrections of the violations and your firm’s compliance with cGMP. Failure to correct these violations may result in FDA refusing admission of articles manufactured at the Hyderabad facility into the United States,” FDA says.

American Peptide expands large-scale synthesis capabilities

American Peptide (Sunnyvale, CA) says it has expanded its large scale cGMP peptide synthesis capabilities with the addition of a 300-liter solid phase synthesis reactor and a 294-liter tray lyophilizer. American Peptide’s cGMP facility is located at Vista, CA. Two additional 50-liter tray lyophilizers have also been recently added to the cGMP facility. With the expansion of the large-scale cGMP synthesis capacity, American Peptide can produce multi-kilograms of active pharmaceutical ingredients (APIs) in individual batches, the company says. Large-scale peptide synthesis helps make the process more economical and shortens delivery times, American Peptide says. American Peptide is a manufacturer of peptides and peptide conjugates. The company offers selections of pre-manufactured catalog peptides, custom synthesis, and GMP peptide APIs.

IMCD widens APIs distribution deal with Fabbrica Italiana Sintetici

Distributor IMCD Group (Rotterdam) says it has concluded a distribution partnership with Fabbrica Italiana Sintetici (FIS, Milan) for its range of active pharmaceutical ingredients (APIs), including anxiolytics, anticonvulsants, antidepressants, analgesics, antiinflammatory agents, antibacterials, antifungals, cardiovascular drugs, diuretics, oncological products, and hormones. The deal covers Hungary, Slovenia, Serbia, Croatia, Macedonia, Bosnia and Herzegovina, Albania, Australia, and New Zealand. The companies' existing partnership already covers a large number of countries in the Maghreb, Central Europe, Eastern Europe, most of CIS, including Russia and Austria.

Beyond IHS Chemical Week:

A shifting landscape for the global API market
from Pharmaceutical Technology

External manufacturing plays a crucial role in pharmaceutical companies’ supply strategy. The author examines market trends for the captive (i.e., in-house ) and merchant (i.e., third-party) global market for active pharmaceutical ingredients and intermediates.
The overall trends of increased globalization, generic-drug incursion, and the rising importance of emerging markets can be further seen in the demand and supply patterns of the API market. In keeping with overall pharmaceutical industry trends, recent growth in the global API market has slowed although the overall market is still increasing at a moderate pace. Led by India and China, Asia Pacific has had the highest recent growth in the API market although North America and the US remain the largest markets, respectively, on a regional and country basis. Generic APIs are outpacing growth for branded, innovator APIs. On a global supply basis, China remains the largest producer of generic APIs, largely for its domestic market as well as the largest exporter of APIs on global basis, primarily to emerging markets. Italy retains its historical position as the largest supplier of generic APIs to both Western Europe and the US although India’s position as a supplier to developed markets is on the rise.

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