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.
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Investment amount
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The first phase covers
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Effective innovative invention patents
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API production approval and filing document number
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Pharmaceutical excipient production approval and filing document number
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Gadolinium contrast agent workshop and anti-tumor workshop passed FDA inspection.
As of April 11, 2024, the API registration situation of Anhui Poly was as follows: 1) 10 were registered in China, 2) 10 obtained US DMF, 3) 5 products are submitted for CEP, 4) 2 products are valid in other markets.
Excipient registration situation of Anhui Poly: 1) 4 registered in China, 2) 5 obtained DMF, 3) 1 submitted for CEP.
API registration situation of Hainan Poly: 19 obtained Chinese registration number, including 17 have been converted to A, 2) 8 with US DMF, 3) 6 with CEP certificate, 4) several for other markets (including EU ASMF, Canada, Brazil, WHO, South Africa, Israel markets).
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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
- 2024-8
- Anhui Poly’s 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
- Anhui Poly was included in the list of Anhui green factories (2024)
- 2024-7
- Anhui Poly Pharm. Obtained CEP Certificate of Excipient Betadex Sulfobutyl Ether Sodium
- 2024-6
- Anhui Poly’s Gadoterate Meglumine API approved for marketing, with annual production capacity of up to 20 tons!
- 2024-5
- Anhui Poly 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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