Anhui Poly Pharm. Co., Ltd., established in 2018 as a wholly-owned subsidiary of Hainan Poly Pharm., and located in Anqing High-tech Zone, a national high-tech park, is a professional supplier of active raw materials. The company invests 1.5 billion yuan, and the first phase covers 187 mu. In terms of design, installation and auxiliary facilities construction, the company strictly follows domestic and foreign advanced environmental protection, health and safety standards and concepts, and is equipped with modern production facilities, and has established a strict CGMP system and EHS system, and is committed to providing chemical synthesis, biosynthesis and high-quality characteristic raw materials and services in fields of pharmaceutical industry, health care and skin care worldwide.
Investment amount
The first phase covers
Effective innovative invention patents
API production approval and filing document number
Pharmaceutical excipient production approval and filing document number
Gadolinium contrast agent workshop and anti-tumor workshop passed FDA inspection.
Passed U.S. FDA follow-up inspection again.
Sodium nitroprusside and voriconazole APIs passed on-site inspection by Brazilian ANVISA.
As of August 2026, API approvals and filing numbers: 40 items. Among them, China NMPA 14 items, U.S. DMF 12 items, EU CEP 6 items, and other markets (Brazil, Canada, South Korea, etc.) 8 items.
Pharmaceutical excipient approvals and filing numbers: 12 items. Among them, China excipient filings 6 items, U.S. DMF 5 items, EU CEP 1 item.
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Company tenet
Good medicine, healthy people -
Company mission
To provide products and services with therapeutic value to customers around the world -
Core values
Integrity Efficiency Innovation Expertise -
Company vision
To become a global supplier of high-quality APIs
- 2024-10
- With WC Certificate obtained for gadobutrol API and COPP for Cyclophosphamide API
- 2024-10
- With Gadoteridol API approved for Chinese market
- 2024-10
- With Memantine Hydrochloride API approved for Chinese market
- 2024-10
- With CEP Certificate obtained for Cyclophosphamide API
- 2024-8
- Pharmaceutical Excipient Betadex Sulfobutyl Ether Sodium Pass the Associated Review in China
- 2024-8
- Mrs. Minhua Fan, CEO of Poly Pharm. Co., Ltd. has contributed the Quality Specifications of API Gadoterate Meglumine to USP.
- 2024-7
- Included in the list of Anhui green factories (2024)
- 2024-7
- Obtained CEP Certificate of Excipient Betadex Sulfobutyl Ether Sodium
- 2024-6
- Gadoterate Meglumine API approved for marketing, with annual production capacity of up to 20 tons!
- 2024-5
- Anti-tumor API cyclophosphamide has been approved for marketing
- 2024-3
- The US DMF of Semaglutide excipient SNAC [8-(2-hydroxybenzamido) sodium caprylate] was submitted in March 2024
- 2023-11
- Awarded as a high-tech enterprise in November 2023
- 2023-11
- The company won the double honorary titles of "Anhui Digital Workshop" and "Anqing Smart Factory" In November 2023
- 2023-11
- Anti-tumor production line and gadolinium contrast agent production line passed FDA inspection successfully in November 2023
- 2023-10
- The company was identified as Anhui Enterprise Research and Development Center in October 2023
- 2023-08
- The company was identified as a specialized new small and medium-sized enterprise in Anhui Province in August 2023
- 2023-06
- The company was identified as a typical demonstration enterprise of Anhui provincial digital transformation
- 2023-02
- Gadoterate meglumine passed the GMP compliance inspection in February 2023
- 2022-09
- The company obtained safety production license in September 2022
- 2022-08
- The first product magnesium hydroxide passed GMP compliance inspection in August 2022.
- 2022-04
- WC (exported to EU) API (Magnesium hydroxide) passed GMP compliance inspection in April 2022
- 2022-03
- The application for first API registration was submitted to NMPA in March 2022
- 2021-09
- Workshop API03 held the production ceremony and workshops 04 and 05 started trial production in September 2021
- 2021-09
- Anhui Poly Pharm. Co., Ltd. signed the phase II project with Anqing High-tech Zone in September 2021
- 2020-04
- The construction of workshop API03 completed in April 2020
- 2020-03
- The construction of the first comprehensive warehouse was completed in March 2020
- 2019-05
- Anhui Poly Pharm. Co., Ltd. held a foundation stone laying ceremony in May 2019
- 2018-12
- Safety evaluation and environment evaluation were completed in December 2018
- 2018-07
- Poly International high-end APIs and innovative preparations project officially settled in Anqing High-tech Zone in July 2018
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