GMP Approved Facility for Tianyin Pharmaceutical granted by China
China Food and Drug Administration (CFDA) has provided Good Manufacturing Practice (GMP) certificate to the Qionglai Tianyin Facility (QLF) of Tianyin Pharmaceutical (TPI). By the end of 2013, suspensions were held for hundreds of nonqualified manufacturers of sterile drugs in China including those of blood products, vaccines and injections as they failed to meet the GMP standards. Therefore, in 2014, inspections were made mandatory to force Chinese manufacturers to comply with stricter GMP regulations.
For complying with the revised GMP standards in early 2011, an optimization process for their manufacturing facilities was initiated by the TPI. By achieving the GMP status at QLF, the company has reached success. Also, this certification lays a strong foundation for the development of the strategic alliance with Buchang Pharmaceuticals formed earlier this month. This alliance is expected to boost the mTCM franchise by focusing on their revenue drive for Gingko Mihuan, a cardiovascular drug.
This GMP-certified Qionglai Tianyin Facility (QLF) has a combination of pre-extraction and formulation plants for the purpose of processing and purifying materials for traditional Chinese medicines. The revised guidelines for obtaining the GMP certificate are strict in terms of standardization, quality control, production facilities and environment therefore, obtaining the revised GMP status is considered to be an advantage for future growth and development in the pharmaceutical industry.
The process of GMP certification began last year after a successful site visit in September, where a thorough examination was carried out by a team of GMP experts, specialists and CFDA officials of the various aspects of the pharmaceutical manufacturing process. Around 58 products are currently manufactured by the TPI. These products come under the categories of cardiology, virology and immunology. Around 20 of these products are mentioned in the highly selective national medicine reimbursement list and 10 are listed in the essential drug list of China.
After forming a strategic alliance with Buchang Pharma on the basis of being GMP-certified, TPI's core product portfolio may increase with integration of additional products.