Proquina A Bayer Company

Transcription

1 Proquina A Bayer Company Producing Active Pharmaceutical Ingredients and Advanced Intermediates

2 Quality Know-how Service

3 Proquina ensuring high quality in line with Bayer standards Reliable what we do, we do right As a subsidiary of Bayer AG, Proquina adheres to strict standards for quality, environmental protection, safety, and production. We ensure the reliable high quality of our products and processes by means of GMP rules and ISO 9001/14001-based processes and regular inspections. Experience our employees know-how Approximately 400 highly-qualified employees work at the production plant in Orizaba. This is where we combine experience with extensive skills. Training programs in GMP, safety, and environmental protection ensure compliance with the latest quality and HSE standards. Versatile tailored to suit your requirements Proquina specializes in the production of active pharmaceutical ingredients and intermediates, particularly for the field of steroid hormones. We find custom-tailored solutions for your products. Proquina company profile The Proquina production plant is located in Orizaba, Mexico, about 280 kilometers (174 miles) east of Mexico City, at 1,200 meters (3,937 feet) above sea level. Proquina is a subsidiary of Bayer. It began operations in 1963 as part of the Germanybased company Schering at its 15-hectare (37-acre) site, producing steroid intermediates and active pharmaceutical ingredients based on the root of the barbasco plant, which grew abundantly in the region. The company supplies products to Bayer s internal and external customers. In collaboration with the Pharma Chemicals business area in Berlin, Germany, we serve external customers in South and Central America, North America, Europe, and other regions. Nearly 400 employees work for Proquina. 3

4 Production and services offering active pharmaceutical ingredients and intermediates as well as custom-tailored services Proquina is acknowledged on the global markets as a reliable company and partner producing to the highest quality standards. We strictly adhere to both national norms and best international standards. Our product portfolio includes a wide variety of steroid hormones and intermediates. The extensive experience of our staff allows us to offer process development services, new molecule production, and tailored product manufacture including the development of analytical methods, compilation of regulatory documentation, isolation and characterization of impurities, and stability testing. Our company is part of Bayer where we play a key role as a low-cost supplier of high-quality active pharmaceutical ingredients and intermediates. We are also considered a reliable supply partner for external clients on the international market for many decades. Close collaboration with the Pharma Chemicals business area of Bayer in commercial activities, personalized customer service, and technical support from experts in the field have allowed us to extend our global presence successfully. Partnering with Proquina, customers benefit from our integrated quality and HSE (Health, Safety, Environment) systems as well as from our ISO 9001 and certifications. These systems ensure production processes with consistently high product quality backed by the required documentation and supply reliability. We are proud to have a company culture oriented toward operational excellence, which includes process optimization through continuous improvement. This allows us to respond quickly to the current and future needs of our customers by providing the necessary resources and capabilities without delay. In addition to standard technical equipment, we also use systems and facilities that have been specifically developed for the field of steroid chemistry from small-scale development in the laboratory to pilot- and industrial-scale production. We have successfully passed a large number of inspections by the FDA as well as other national and international authorities clear recognition of our commitment and a success guarantee for our customers. 4

5 certified tailor-made strategic Product solutions tailor-made development and production We are the right choice when it comes to the professional production of active pharmaceutical ingredients and their intermediates. Our specialty is the development and production of steroid hormones. We offer the option of customized production of active pharmaceutical ingredients according to the specific needs of our customers. After carrying out feasibility studies and adapting our facilities to the specific requirements of each product, we ensure the supply of necessary raw materials in order to guarantee consistent quality. Our steroid manufacturing processes are backed by modern analytic control and meticulous documentation. At Proquina, we are in constant communication with our customers to efficiently coordinate all production-related activities. We offer integrated technical, chemical, and strategic product solutions, all from a single source. Inspections and audits > FDA (Food and Drug Administration, USA), EMA (European Medical Agency) > TGA (Therapeutic Goods Administration, Australia) > PMDA (Pharmaceuticals and Medical Devices Agency, Japan) > COFEPRIS (Federal Commission for the Protection against Sanitary Risks, Mexico) > ISO 9001 & ISO audits > Frequent customer audits 5

6 Our portfolio Our product portfolio includes a wide variety of active pharmaceutical ingredients and intermediates, specifically for the field of steroid hormones. Proquina is acknowledged on the global markets as a reliable company and partner producing to the highest quality standards. We strictly adhere to both national norms and international standards. CAS NO. PRODUCT REGULATORY DOCUMENTS ANDROGENS Testosterone USDMF, AUSTRALIAN DMF, NEW ZEALAND DMF, CANADIAN DMF & CEP Testosterone Enanthate USDMF & CEP Testosterone Undecanoate USDMF & ASMF Prasterone USDMF, CANADIAN DMF, ASMF Prasterone Enanthate Technical PACKAGE ESTROGENS alpha Estradiol USDMF Estradiol Benzoate Technical PACKAGE Estradiol Enanthate Technical PACKAGE Estriol CEP PROGESTOGENS Dihydroxyprogesterone Acetophenide Technical PACKAGE (Algestone Acetophenide) Progesterone USDMF & CANADIAN DMF, cep Danazol USDMF INTERMEDIATES Alpha Methyl Acetoxy Pregnenolone (MAP) Technical PACKAGE AD 17-Carboxylic acid Technical PACKAGE Boldenone Technical PACKAGE Ethisterone Technical PACKAGE Mestanolone Technical PACKAGE We also offer the customized production of active pharmaceutical ingredients and intermediates, beyond the products listed, to meet the specific needs of our customers. 6

7 Our services CHEMICAL and TECHNICAL DEVELOPMENT Chemical development of manufacturing processes and syntheses Optimization of existing manufacturing processes and syntheses Scale-up work Micronization Analytical development and validation Regulatory support LABORATORY SUPPORT Synthesis and development of reference standards and working standards Synthesis, isolation, and characterization of impurities Studies of stability Photo stability Stress test REGULATORY AFFAIRS We offer the technical support necessary to meet the requirements of authorities and customers. This includes the preparation, maintenance, and updating of all necessary regulatory documents for: Product registrations and management in conjunction with the relevant authorities (DMFs) Technical packages Certificates of suitability to the monographs of the European Pharmacopoeia (CEPs) MAIN REACTIONS Epoxidation Halogenation Hydrogenation Hydride-based reduction Organometallic reductions Esterification Ethinylization Oxidation FACILITIES AND EQUIPMENT Production facilities 2 plants for intermediates 3 plants for APIs 1 kilo lab 1 plant for solvent recovery Process development lab Equipment available Reactors (250 to 7,500 liters) Centrifuges Vacuum dryers Nutsche filter/dryers Homogenizers Micronizers Distillation columns Our staff Some 400 highly qualified employees work at our production plant in Orizaba, Mexico. A comprehensive training system ensures broad knowledge and required skills at all times. We guarantee a high level of experience in our production and support processes. Our customers benefit from Proquina s extensive experience in the field of steroids, our competitive production costs and our reliable product quality. 7

8 For more information, please contact our customer service department: Customer service Productos Químicos Naturales S.A. de C.V. (Proquina) Domicilio Conocido Ojo de Agua Ixtaczoquitlán, Veracruz México Phone: Fax: Pharma Chemicals Bayer Pharma AG Müllerstraße 178 D Berlin Germany Phone: or Legal disclaimer: This information and our technical advice whether verbal, in writing or by way of trials are given in good faith but without warranty. This also applies where proprietary rights of third parties are involved. Our advice does not release you from your obligation to verify current information in particular, information relating to our safety data or our technical information sheets and to test our products as to their suitability for the intended processes and uses. The application, use, and processing of our products and the products manufactured by you on the basis of our technical advice are beyond our control and, therefore, entirely your own responsibility. Our products are sold in accordance with the current version of our General Conditions of Sale and Delivery. September 2016 Bayer Pharma AG Pharma Chemicals Berlin, Germany