Farmhispania Group, a leading European CDMO in HPAPI Technologies & High Potency Fermentation.
01 1Farmhispania, S.A. Montmeló ES
02 1ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN
03 1CIPLA LIMITED Mumbai IN
04 1HETERO LABS LIMITED Hyderabad IN
05 1MAC CHEM PRODUCTS (INDIA) PVT. LTD. Mumbai IN
06 1MSN LABORATORIES PRIVATE LIMITED Kardanur Village IN
07 1NATCO PHARMA LIMITED Hyderabad IN
08 1SHANDONG ANHONG PHARMACEUTICAL CO., LTD. Dezhou City CN
09 1SICHUAN XIELI PHARMACEUTICAL CO., LTD. Pengzhou CN
10 1SYNTHON BV Nijmegen NL
11 1Wisdom Pharmaceutical Co., Ltd. Haimen CN
12 1ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Linhai CN
13 1ZHEJIANG JIUZHOU PHARMACEUTICAL CO. LTD. Taizhou CN
Farmhispania Group, a leading European CDMO in HPAPI Technologies & High Potency Fermentation.
Certificate Number : R1-CEP 2016-305 - Rev 00
Status : Valid
Issue Date : 2022-10-06
Type : Chemical
Substance Number : 2866
19
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A IRE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of IRE, including repackagers and relabelers. The FDA regulates IRE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. IRE API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A IRE supplier is an individual or a company that provides IRE active pharmaceutical ingredient (API) or IRE finished formulations upon request. The IRE suppliers may include IRE API manufacturers, exporters, distributors and traders.
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A IRE CEP of the European Pharmacopoeia monograph is often referred to as a IRE Certificate of Suitability (COS). The purpose of a IRE CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of IRE EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of IRE to their clients by showing that a IRE CEP has been issued for it. The manufacturer submits a IRE CEP (COS) as part of the market authorization procedure, and it takes on the role of a IRE CEP holder for the record. Additionally, the data presented in the IRE CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the IRE DMF.
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