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cGMP Contract Manufacturing For companies needing to outsource their manufacturing, Sypharma offers contract manufacturing services to the pharmaceutical, veterinary and consumer goods industries, with a specialist program for clinical trial material and drug development. As Sypharma expands its chemical and microbiological laboratories we can increasingly offer extra laboratory services. We provide you with a broad range of formulations, batch sizes, and packaging formats to accommodate your requirements. Our Fully GMP licensed manufacturing facility is centrally located in Melbourne's South Eastern business area enabling logistical ease for distribution. Sypharma's track record speaks for itself; we have established alliances with some of the world's largest human and veterinary pharmaceutical companies. Our expertise in analytical methods and regulatory affairs allows contract manufacturing partners to reap the benefit of having their products reach markets faster. We offer a cost effective option, with production capability, manufacturing flexibility and most importantly, our commitment to quality ensures that your product complies with current licensing standards. Sypharma can provide all or part of the support services associated with production, testing, and release-for-sale of human and veterinary pharmaceutical products and consumer goods. Sypharma is licensed to aseptically Fill and Finish for Phase I, II and III Clinical Trials, and specialises in small run manufacturing. Sypharma offers a complete solution to your Drug Development needs, and can provide services from R & D through to commercial supply. We are also happy to provide facility rental with our trained GMP operators for assistance. Please read the FDA and EMEA Guidelines for Manufacture of investiogational drugs. For sterile drugs, sterility assurance is required as for Commerical Product. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070273.pdf http://ec.europa.eu/health/files/eudralex/vol-4/2009_06_annex13.pdf The TGA has formally adopted the PICS Guidelines as of 1st July 2010, which means whilst Phase 1 investigational drugs dont require full GMP, sterile phase one products require the same sterility assurance as products supplied commerically. http://www.tga.gov.au/docs/html/gmpcodqa.htm#a13 http://www.tga.gov.au/manuf/picsgmpmed.htm Clause 17 of Annex 13 Production processes for investigational medicinal products are not expected to be validated to the extent necessary for routine production but premises and equipment are expected to be validated. For sterile products, the validation of sterilising processes should be of the same standard as for products authorised for marketing. Likewise, when required, virus inactivation/removal and that of other impurities of biological origin should be demonstrated, to assure the safety of biotechnologically derived products, by following the scientific principles and techniques defined in the available guidance in this area. Our Contract Manufacturing Services Include:
We Can Manufacture:
We Offer:
To discuss contract manufacturing opportunities - Download Application or email us!
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