01 1CARBOGEN AMCIS B.V. Veenendaal NL
02 1DSM Nutritional Products Ltd. Basel CH
03 1FORMOSA LABORATORIES, INC. Taoyuan TW
04 2LUKASIEWICZ RESEARCH NETWORK- INDUSTRIAL CHEMISTRY INSTITUTE Warsaw PL
01 4Calcifediol monohydrate
02 1Calcifediol monohydrate, L
01 2Poland
02 1Switzerland
03 1Taiwan
04 1U.S.A
01 3Valid
02 2Withdrawn by Holder
Certificate Number : CEP 1998-059 - Rev 09
Status : Valid
Issue Date : 2024-12-02
Type : Chemical and TSE
Substance Number : 1295
Certificate Number : CEP 2019-163 - Rev 02
Status : Valid
Issue Date : 2024-08-27
Type : Chemical
Substance Number : 1295
Certificate Number : R0-CEP 2022-335 - Rev 00
Status : Valid
Issue Date : 2022-11-29
Type : Chemical
Substance Number : 1295
Certificate Number : R0-CEP 2015-359 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2022-08-09
Type : Chemical
Substance Number : 1295
Certificate Number : R1-CEP 1999-101 - Rev 02
Status : Withdrawn by Holder
Issue Date : 2012-06-07
Type : Chemical
Substance Number : 1295
A Calcifediol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Calcifediol, including repackagers and relabelers. The FDA regulates Calcifediol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Calcifediol API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Calcifediol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Calcifediol supplier is an individual or a company that provides Calcifediol active pharmaceutical ingredient (API) or Calcifediol finished formulations upon request. The Calcifediol suppliers may include Calcifediol API manufacturers, exporters, distributors and traders.
click here to find a list of Calcifediol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Calcifediol CEP of the European Pharmacopoeia monograph is often referred to as a Calcifediol Certificate of Suitability (COS). The purpose of a Calcifediol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Calcifediol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Calcifediol to their clients by showing that a Calcifediol CEP has been issued for it. The manufacturer submits a Calcifediol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Calcifediol CEP holder for the record. Additionally, the data presented in the Calcifediol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Calcifediol DMF.
A Calcifediol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Calcifediol CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Calcifediol suppliers with CEP (COS) on PharmaCompass.
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