Consistent high quality. Reliable supply security. Now available for generic APIs, intermediates and phosphonium salts.

Transcription

1 Consistent high quality. Reliable supply security. Now available for generic APIs, intermediates and phosphonium salts.

2 About Evonik In 2011, our approximately 33,000 Evonik employees produced sales of 14.5 billion and an operating result (EBITDA) of 2.8 billion. More than 70 percent of sales are generated outside Germany, providing convincing evidence that our business is global. Our business activities are aligned with three global mega-trends: besides resource efficiency and globalization, our focus is also on the key growth sector of health and nutrition. Here, the pharma industry is part of the strategic core business of Evonik, and it has been for several decades. As Evonik and Degussa, our track record builds on 40 years of experience in the production of pharma ceutical-grade products. Our Health Care Business Line is firmly embedded within the Evonik Group, enabling us to promise our customers stability and staying power both essential for building long-term partnerships.

3 Generic APIs Generic APIs CAS number Chlorhexidine Digluconate Chlorhexidine Diacetate Chlorhexidine Dihydrochloride Dimercaprol Lisinopril Dihydrate Lorazepam Lormetazepam Bisoprolol Fumarate Nifedipine α-hydroxymethionine, Calcium s; (Calcium bis[(±)-2-hydroxy-4-(methylthio)butyrate]) α-ketoisoleucine, Calcium s; (DL-Calcium bis(3-methyl-2-oxovalerate)) α-ketoleucine, Calcium s; (Calcium bis(4-methyl-2-oxovalerate)) α-ketophenylalanine, Calcium s; (Calcium bis(2-oxo-3-phenyl-propionate)) α-ketovaline, Calcium s; (Calcium bis(3-methyl-2-oxobutyrate)) For more information go to our website:

4 Hanau Ham Dossenheim senheim Lafayette Parsippany São Paulo Sales offices GMP production and process development Five production locations countless options. We have the right equipment for every project USA: Lafayette Four cgmp plants and pilot plant, 140 vessels, sizes m³, cgmp kilo lab. Development, scale-up and production facilities for highly potent APIs High-volume APIs, high-potency capabilities (< 0.1μg/m³), lowtemperature reactions, large-scale fermentation Twenty years experience in manufacturing highly potent APIs Germany: Dossenheim Two cgmp plants, multi-purpose plant, pilot plant, 36 vessels, sizes m³ APIs Germany: Hanau Three cgmp plants, including pilot plant, 42 vessels, sizes m³ APIs, cgmp hydrogenation, phosgene, HCN handling, lowtemperature chemistry, enzyme catalysis, peptide formation France: Ham Three cgmp plants, including pilot plant, sizes m³ Amino acid and peptide purification Purification services China: Nanning One cgmp plant and four amino acid plants, 47 vessels, m³ APIs, amino acids, fermentation, biocatalysis Continuous reactions Controlled crystallization and ion exchange technology

5 Incheon Shanghai Nanning Tokyo Mumbai Quality is the top priority. Minimizing risks is too. There s more to quality than meets the eye: safety We manufacture all your products, whether intermediates, APIs or phosphonium salts, to strict quality standards. The result is not just products of the best possible caliber we also maximize the safety of production processes. As we employ only our own staff in our own facilities, we have implemented uniform Western standards at all our locations in China, too. All our plants have been audited by the FDA or other independent organizations, many of them state run. Manufacturing follows cgmp guidelines rigorously and meets environmental, health and safety standards. But don t take our word for it; ask your quality assurance specialists: we ll be working closely with them. Our approach to safety is comprehensive: all staff members in production get precampaign training for the job s special demands, and all production stages are carried out in accordance with clearly defined standard operating procedures.

6 Each production site has dedicated process R & D experts who get to know the production process from the planning stage. They are involved throughout the production cycle with assessments aimed at improving the process. The result: the ultimate in product quality and product safety. As a reliable partner, we deliver the grades and quantities you require in full and on time. Our responsibility doesn t end at your receiving dock. Besides supply security you can trust, we offer technical service to address any issues you may encounter after delivery, from optimizing handling and processing at your site to aspects as far downstream as hands-on support in obtaining regulatory approvals. Because we understand how important it is to provide the full package, not just the product. Environmental compliance We are committed to maintaining and continuously improving on the most stringent health, safety and environmental standards. Compliance with legislation is the baseline and all sites operate to common standards, often exceeding local regulatory requirements. Several sites have liquid waste and gaseous by-product incineration facilities; all plants have off-gas treatment (incinerators and/or scrubbers) and wastewater treatment capabilities. Environmental, safety and health services Process hazard and safety evaluation and testing Specialized handling of hazardous products and processes Analysis and treatment of gaseous, liquid and solid wastes Workforce health monitoring Toxicology group Regulatory services Process validation and respective documentation Preparation of Drug Master Files, CEPs, NDA and IND submissions in cooperation with customers Preparation of REACH submissions, including product testing

7 Intermediates and phosphonium salts Intermediates CAS number (Ethoxycarbonylmethylene)triphenylphosphorane (Ethoxycarbonyl)ethylidenetriphenylphosphorane (1,1-Dimethylethoxycarbonylmethylene) triphenylphosphorane Amino-benzophenone Amino-5-chlorobenzophenone Amino-2,5-dichlorobenzophenone (Bromoacetamido)-5-chlorobenzophenone (Bromoacetamido)-2,5-dichlorobenzophenone (Bromoacetamido)-2 -fluoro-5- chlorobenzophenone 2-(Chloroacetamido)-2 -fluoro-5- bromobenzophenone (Chloroacetamido)-5-chlorobenzophenone (Chloroacetamido)-2,5-dichlorobenzophenone Phosphonium salts Butyltriphenylphosphonium bromide (4-Carboxybutyl)triphenylphosphonium bromide Ethyltriphenylphosphonium bromide Methyltriphenylphosphonium bromide Propyltriphenylphosphonium bromide Benzyltriphenylphosphonium chloride Ethyltriphenylphosphonium chloride (Methoxymethyl)triphenylphosphonium chloride Ethyltriphenylphosphonium iodide

8 This information and all technical and other advice are based on Evonik s present knowledge and experience. However, Evonik assumes no liability for such information or advice, including the extent to which such information or advice may relate to third party intellectual property rights. Evonik reserves the right to make any changes to information or advice at any time, without prior or subsequent notice. EVONIK DISCLAIMS ALL REPRESENTATIONS AND WAR- RANTIES, WHETHER EXPRESSED OR IMPLIED, AND SHALL HAVE NO LIABILITY FOR, MERCHANTABILITY OF THE PRODUCT OR ITS FITNESS FOR A PARTICULAR PURPOSE (EVEN IF EVONIK IS AWARE OF SUCH PURPOSE), OR OTHERWISE. EVONIK SHALL NOT BE RESPON- SIBLE FOR CONSEQUENTIAL, INDI- RECT OR INCIDENTAL DAMAGES (INCLUDING LOSS OF PROFITS) OF ANY KIND. It is the customer s sole responsibility to arrange for inspection and testing of all products by qualified experts. Reference to trade names used by other companies is neither a recommendation nor an endorsement of the corresponding product, and does not imply that similar products could not be used. Evonik Industries AG Exclusive Synthesis Product Line exclusive-synthesis@evonik.com 02 / engl.-VC-Medien-Printed in Germany