Tianyin Pharmaceutical, a pharmaceutical company that specialises in the development and sale of patented biopharmaceutical medicine, modernised TCM, branded generics and API, updated on the business and development at its Jiangchuan Macrolide Facility (JCM) API operation.

In addition to JCM's certification at India, along with other international clients located at Bangladesh, Philippines and Iran on import status, TPI plans for FDA certification process at its JCM facility in order to service international clients such as Pfizer's  and their subsidiaries in China. This is expected to translate to further demand for JCM's macrolide API business in both the domestic and international markets.

Azithromycin (Azi) is a macrolide antibiotic related to erythromycin. It is used primarily to treat various bacterial infections caused by respiratory pathogens, such as Aerobic gram-positive microorganisms and Aerobic gram-negative microorganisms. Azi prevents bacterial cells from manufacturing specific proteins necessary for their survival. Azi is rapidly absorbed and is widely distributed to tissues and becomes concentrated in cells. Peak plasma concentrations are achieved within 2 to 3 hours. Azi Amine is a close intermediate of Azi and enjoys competitive pricing trends amongst various derivatives of Azi related products. Comprehensive testing and improvement on quality, purity, stereochemistry, stability in compliance with the international standards of Azithromycin API have been conducted at JCM for the past year to develop sales network with both domestic and international buyers. Previously JCM has been receiving orders to manufacture one of the major intermediates of Azithromycin, Azithromycin amine (Azi Amine) at a competitive international price. And the increasing demand for Azithromycin API necessitates the application for certificate of import.

Drug Master File or DMF is a document prepared by a pharmaceutical manufacturer and submitted to the appropriate regulatory authority at the intended drug market. DMF provides the regulatory authority with confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more drugs. The DMF filing allows a company to protect its intellectual property from its partner while complying with regulatory requirements for disclosure of processing details. In the United States, DMFs are submitted to the Food and Drug Administration (FDA). The Main Objective of the DMF is to support regulatory requirements and to prove the quality, safety and efficacy of the medicinal product for obtaining an Investigational New Drug Application (IND), a New Drug Application (NDA),As an Abbreviated New Drug Application (ANDA), another DMF, or an Export Application.