Tianyin Pharmaceutical's Qionglai Facility completes official GMP site visit by CFDA

Sep 29 2014

Tianyin Pharmaceutical Co., Inc. (NYSE Amex: TPI), a pharmaceutical company that specializes in patented biopharmaceutical, modernized traditional Chinese medicine (mTCM), branded generics and active pharmaceutical ingredients (API), today announced that its Qionglai Facility (QLF) has successfully completed the official site visit by the China Food & Drug Administration's (CFDA) for its Good Manufacturing Practice (GMP) certification.

In early September 2014, the Company has submitted the GMP dataset for CFDA review, following final rounds of test runs at QLF following months of preparation and production optimization. The site visit is a critical component for GMP certification during which a team of GMP experts and specialists along with CFDA officials conduct a thorough examination of production facility in terms of pre-extraction process, formulation process and various aspects of the pharmaceutical manufacturing procedure. The successful completion of the site visit is required for the final issuance of GMP certificate for QLF. TPI is currently preparing the smooth transition of production capacity from the current Longquan plant to the new QLF in the coming months.

The QLF is a combination of both pre-extraction plant and formulation plant. The pre-extraction facility is designated for processing and purifying raw materials for TCMs using ethanol or distilled water precipitation, filtration, centrifugation, concentration and purification. The TCM extracts will then be processed for the production of mTCM products at the formulation facility where the final biopharmaceutical, TCM and generic products in the forms of oral liquid, granules, tablets, and capsules are produced.