China's FDA Revokes Pharmaceutical Firm's Drug GMP Certificate Over Data Falsification
Yicai Global
/SOURCE : Yicai
China's FDA Revokes Pharmaceutical Firm's Drug GMP Certificate Over Data Falsification

(Yicai Global) June 2 -- China's Food and Drug Administration (CFDA) has sanctioned Guangdong Danxia Biological Pharmaceutical Co., an affiliate of Chinese blood-product maker Jiangxi Boya Bio-Pharmaceutical Co. [SHE:300294], for falsifying its human serum albumin stability data.

CFDA revoked its good manufacturing practices (GMP) certificate for drugs, ordered it to stop producing and distributing human serum albumin and to timely and publicly recall its products.

The company doctored sample names and deleted test records to redo tests in nine batches of human serum albumin products submitted for product registration, CFDA said in an administrative penalty ruling it issued yesterday.

CFDA will investigate the company's illegalities and irregularities, impose heavy penalties on it and ensure that the courts also impose legal liability on it, the agency said. A buyout fund backed by Jiangxi Boya and its controlling shareholder -- Shenzhen-based GTJA Investment Group Co. -- holds a 99 percent stake in Guangdong Danxia. Jiangxi Boya will purchase hundreds of tons of plasma and plasma components from Guangdong Danxia over the next 24 months, the former said.

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Keywords: Pharma , Blood Products , VIOLATION , GAFDA