SINGAPORE--The Qionglai Tianyin Facility (QLF) of Tianyin Pharmaceutical (TPI) received its Good Manufacturing Practice (GMP) certificate from the China Food and Drug Administration (CFDA) this week, notching up an important certificate to be able to sell at home and abroad.
Hundreds of nonqualified manufacturers of sterile drugs in China were suspended last year, including those that make blood products, vaccines and injections for failing to meet GMP standards by the end of 2013. China's FDA has worked to beef up inspections in 2014 as more regulators in Asia joined PIC/S to harmonize inspections, forcing Chinese manufacturers to grapple with stricter GMP regulations in more markets.
TPI initiated an optimization process of their manufacturing facilities to comply with the revised GMP standards in early 2011. The GMP status at QLF is an important milestone for the company. This certification also serves as a strong foundation for the development of the strategic alliance with Buchang Pharmaceuticals formed earlier this month, according to a press statement.
TPI's alliance with Buchang Pharma, a leading Chinese pharmaceutical company with specializations in the research and development of modernized traditional Chinese medicine (mTCM) and cardio-cerebrovascular drugs, is expected to boost the mTCM franchise by focusing on their revenue drive, Gingko Mihuan, a cardiovascular drug.
The GMP-certified Qionglai Tianyin Facility (QLF) combines pre-extraction and formulation plants to process and purify materials for traditional Chinese medicines.
The revised regulations for the GMP certificate are significantly stricter in terms of standardization, quality control, production facilities and environment. Receiving the new GMP status is held in high regard as a prominent advantage for future growth and development in the pharmaceutical industry.
The GMP certification process began last year after successful completion of a site visit in September, where a team of GMP experts, specialists and CFDA officials carried out a thorough examination of various aspects of the pharmaceutical manufacturing process.
TPI currently manufactures 58 products, most of which are in the categories of cardiovascular, viral infection and immunology. More than 20 of these products are under the highly selective national medicine reimbursement list and 10 are registered in the essential drug list of China.
TPI's core product portfolio may increase with integration of additional products after forming a strategic alliance with Buchang Pharma on the basis of being GMP-certified.
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