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Adcock Ingram Receives FDA Accreditation For Its Wadeville Manufacturing Facility

2013/03/28 00:00:00

Adcock Ingram today announced that the Centre for Drug Evaluation and Research of the US Food and Drug Administration (FDA) has accredited the company’s Wadeville Manufacturing facility, located in Germiston, East of Johannesburg. Adcock’s Wadeville pharmaceutical facility is also certified by the Medicines Control Council (MCC) of South Africa as a current Good Manufacturing Practice facility.

The FDA accredited Adcock’s Wadeville facility following an inspection of the plant’s manufacturing and testing activities. This follows the August 2012 FDA acceptance of Adcock Ingram’s Research & Development establishment.

Adcock’s Wadeville Facility is responsible for the manufacture and testing of critical medication, such as anti-retrovirals (ARVs), creams and effervescents. The Wadeville plant will be used in the manufacturing of the R825 million portion of the Department of Health’s (DoH) ARV tender awarded to Adcock in December 2012.

“The FDA’s acceptance of the Wadeville facility is evidence of the quality of systems and processes at Adcock Ingram’s manufacturing plants – we provide products and services that consistently exceed customer expectations. The FDA accreditation is key to Adcock’s strategy of building our business outside South African borders as FDA approval is a pre-requisite to accessing donor funding and being able to fulfil tenders in the rest of Africa. It also serves as a stepping stone to ensuring global best practices are in place across all our production sites” said Adcock Ingram Medical Executive Dr Abofele Khoele.

About the Wadeville facility
The Wadeville Manufacturing facility has the capacity to produce 6 Million Litres of syrups and liquids, 500 000kg creams, 2 billion tablets and capsules.
To achieve scientific and technical objectives, while maintaining the highest level of quality assurance and regulatory compliance, a comprehensive Quality Management System (QMS) has been implemented at the factory. This allows for a feedback mechanism on systems and processes, ensuring continuous improvement in the development and testing of pharmaceutical products