Articles
HollisterStier Contract Manufacturing And Draxis Pharma Complete Successful FDA, PMDA And Health Canada Audits
March 15, 2010
Jubilant Organosys, a leading integrated pharma and life sciences company headquartered in India, announced today that two of its contract manufacturing facilities in North America successfully completed regulatory authority cGMP audits, recently.
HollisterStier Contract Manufacturing, based in Spokane Washington, U.S.A, completed a successful audit by the Japanese Pharmaceutical and Medical Device Agency (PMDA) for the review of a sterile injectable client product. Draxis Pharma, based in Montreal, Quebec, Canada, also completed a successful audit by the US Food and Drug Administration (FDA) and Health Canada.
HollisterStier
The audit by the Japanese Pharmaceutical and Medical Device Agency (PMDA)
revealed no significant observations, which has resulted in a
recommendation to the MHLW that Hollister-Stier be listed as an approved
manufacturing site for the client's product. Independent of the PMDA
audit, the HollisterStier facility was also recently approved by the
European Medicines Agency (EMA) as a manufacturing site for this same
product.
Draxis Pharma
The audit of Draxis Pharma by the US Food and Drug Administration (FDA)
included a comprehensive cGMP review of both sterile parenteral and
non-sterile semi-solid manufacturing capabilities and a Pre-Approval
Inspection for three client products. No observations were received from
this audit. Recommendations for site approvals for the three new client
products are expected. The audit of Draxis Pharma by Health Canada focused
on a cGMP review of a dedicated packaging capability and revealed no
significant audit observations.
Marcelo Morales, CEO of HollisterStier Contract Manufacturing and Draxis Pharma, said "We are extremely pleased with the audit findings at both our HollisterStier and Draxis Pharma facilities. Maintaining a rigorous quality culture and robust quality systems, combined with effectively managing our clients' projects, assures the success of these projects in the global market place."
About Jubilant Organosys
Jubilant Organosys Ltd., an integrated pharmaceutical industry player, is
the largest custom research and manufacturing services (CRAMS) out of
India. The company has a presence across the pharmaceutical value chain for
providing products and services such as proprietary products, exclusive
synthesis, active pharmaceutical ingredients, contract manufacturing of
sterile injectables & non-sterile products, radiopharmaceuticals, generic
dosage forms, drug discovery services, medicinal chemistry services,
clinical research services, Life Science Chemicals, Nutrition Ingredients
and Health Care. The Company also manufactures Agri and Performance Polymer
products. For more information please visit:
www.jubl.com.
About HollisterStier Contract Manufacturing and DRAXIS Pharma
HollisterStier Contract Manufacturing and DRAXIS Pharma are separately
branded contract manufacturing organizations that joined capabilities and
services under the ownership of Jubilant Organosys. HollisterStier is a
global manufacturing service provider, able to aseptically fill liquid and
lyophilized products at their Spokane, Washington, U.S.A., facility and
DRAXIS Pharma offers manufacturing services for sterile liquid and sterile
and non-sterile semi-solid dosage forms at their Montreal, Quebec, Canada,
facility. Manufacturing facilities for solid dosage forms are also
available in the United States and India through HollisterStier and DRAXIS.
Both organizations offer highly-skilled, cross-functional teams to provide custom solutions to customer-specific project goals from development through commercialization. HollisterStier and DRAXIS are committed to providing exceptional quality, regulatory expertise and operational excellence to ensure streamlined processes and services in all facilities. For more information about HollisterStier Contract Manufacturing, please visit HScontract.com and for more information about DRAXIS Pharma, visit DRAXISPharma.com.
