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Therapex is a provider of turnkey outsourced drug development and manufacturing services with over 40 years of experience specializing in semi-solid and liquid products. Therapex offers a complete range of manufacturing services under one roof, including formulation and development, quality control and production of small or large commercial batches. Medical imaging and contract manufacturing of semi-solid and liquid productsDedicated to excellence, Therapex is a dynamic, customer-driven contract manufacturer, recognized for providing quality products and services to our partners in the global pharmaceutical industry. Being a total resource company, we supply the skills, technological capabilities and cost competitiveness that you require in today’s marketplace. We are acknowledged by the Canadian (TPP), American (FDA) and European Union regulatory agencies for our outstanding quality and regulatory compliance history. In medical imaging and contract manufacturing, our team strives to make your vision a reality. Contract manufacture of oral liquid and topical health care productsTherapex has expertise in the contract manufacture of oral liquid and topical health care products. For both small and large volumes we offer product development, technology transfer, commercial manufacturing and packaging, product and process validation, analytical chemistry, microbiology, test method development and validation, ICH stability and FDA regulatory compliance. Therapex’s comprehensive analytical and quality control laboratories support development and production requirements. Chemistry and microbiology labs for contract manufacture of semi-solid and liquid productsOur facility has a total size of 150,000ft² and the site operates 24 hours/day. The production area and the chemistry and microbiology laboratories, including ICH stability rooms, cover 35,000ft². Our company’s workforce of over 300 full-time, well-trained employees is dedicated to consistently meeting the specific needs of each customer. Therapex’s validation department offers complete services for equipment qualification, cleaning process and packaging validation. Manufacture of oral and topical products, creams, ointments and gelsTherapex can process hard-to-handle ingredients and complex formulae, and operate under special conditions such as inert gas. Oral and topical (prescription and OTC) solution, dispersion and suspension product types manufactured include, among others, syrups, antacids, laxatives, nasal sprays, medicated shampoos, sunscreens and acne treatments. Packaging capabilities include glass and plastic bottle filling, plastic and polyfoil tubes, insertion of pumps and droppers, labeling and cartoning. Our capacity extends to the production of creams, ointments and gels. Stability programs for formulation evaluation, clinical supplies and commercial finished productsTherapex has a fully equipped cGMP compliant chemistry and microbiology laboratory. Our scientists develop and validate in-house new analytical methods for drug substances, drug products, impurities and degradants, and cleaning methods. Therapex provides its customers with comprehensive stability programs for formulation evaluation, clinical supplies and commercial finished products, including study protocols, summary reports and recommendations for shelf life. Three fully validated ICH conditions stability chambers are on site. Drug product serializationTherapex has also started a project to implement serialization of drug product to comply with E-pedigree requirements. Our analytical and microbiology services team operates under cGMP and ICH guidelines and is compliant to US, EU and Canadian regulations. Therapex is your key partner in contract manufacturing.
Therapex
Division of E-Z-EM Canada, Inc. 11065 L-H Lafontaine Blvd Anjou Quebec H1J 2Z4 Canada Tel: +1 800 465 5820 (Canada and US toll-free) Tel: +1 514 353 5820 Fax: +1 514 353 9968 Email: info+@therapex.com URL: www.therapex.com |
![]() Therapex provides outsourced drug development and manufacturing services, and has over 40 years of experience in the contract manufacture of semi-solid and liquid products. ![]() Therapex has expertise in the contract manufacture of oral liquid and topical health care products, and can offer product development, technology transfer, commercial manufacturing and packaging, product and process validation, analytical chemistry, microbiology, test method development and validation, ICH stability and FDA regulatory compliance. ![]() Therapex provides its customers with comprehensive stability programs for formulation evaluation, clinical supplies and commercial finished products, including study protocols, summary reports and recommendations for shelf life. |