PRESS RELEASE - 12TH JUNE 2012

Sypharma launches optimum range of Gerresheimer Vials, Moulded Pharma Containers and Test Tubes to the Australian market. 

SYPHARMA NOW TGA LICENSED TO MANUFACTURE TRANSDERMAL GELS, MEDICAL DEVICES AND BIOPHARMACEUTICALS

Over the last 6 months Sypharma has gained license extensions for Transdermal Gels, Medical Devices and Biopharmaceuticals.  We can now offer these as well as our sterile and non sterile liquids for commerical use or clinical trials.

SYPHARMA GAINS CONFORMITY ASSESSMENT ISO 13485;2003

Contact us for your medical device manufacturing

TGA has formally adopted the PICS Guide to GMP for Medicinal Products from 1st July 2010 meaning Annex 13 now applies to the Manufacture of Investigational Products

http://www.tga.gov.au/manuf/picsgmpmed-annexes.pdf

FDA Guidance on Manufacturing for Clinical Trials  

http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070273.pdf

SYPHARMA GAINS EXTENSION OF TGA LICENSE FOR BIOFORMULATION AND PROTEIN PURIFICATION

Sypharma has now received notification from the TGA of its extension of license allowing us to offer contract protein purification services, as well as contract formulation and aseptic processing of solutions to GMP standard for clinical trials or commercial manufacture.

Sypharma has developed this area to provide a personalised, fast service to the Australian Biotech Industry.

Our manufacturing facility supplies both large and small volume parenteral solutions for clinical trial and commercial production.  We have capabilities for aseptic manufacturing and filling of vials, as well as in-house terminal sterilization capabilities. In addition we offer chemical and microbiological analytical services, powder and cream manufacture as well as labelling and packaging services.

Please call us to discuss how Sypharma can satisfy your future requirements.