01 1CARBOGEN AMCIS B.V. Veenendaal NL
02 2Cerbios-Pharma SA Barbengo CH
03 2FORMOSA LABORATORIES, INC. Taoyuan TW
04 1Instytut Farmaceutyczny Warsaw PL
05 1JESALIS PHARMA GMBH Jena DE
06 1MICROBIOPHARM JAPAN CO., LTD. Tokyo JP
07 1TEVA PHARMACEUTICAL INDUSTRIES LTD Tel Aviv - Jaffa IL
01 8Calcitriol
02 1Calcitriol, Process 2 (F007V1)
01 1Germany
02 1Israel
03 1Japan
04 1Poland
05 3Switzerland
06 2Taiwan
01 7Valid
02 2Withdrawn by Holder
Certificate Number : CEP 1996-009 - Rev 13
Status : Valid
Issue Date : 2024-12-13
Type : Chemical and TSE
Substance Number : 883
Certificate Number : R1-CEP 2012-356 - Rev 00
Status : Valid
Issue Date : 2019-02-20
Type : Chemical and TSE
Substance Number : 883
Calcitriol, Process 2 (F007V1)
Certificate Number : CEP 2020-150 - Rev 02
Status : Valid
Issue Date : 2024-12-18
Type : Chemical
Substance Number : 883
Certificate Number : CEP 2009-377 - Rev 02
Status : Valid
Issue Date : 2024-12-18
Type : Chemical and TSE
Substance Number : 883
Certificate Number : R1-CEP 1995-023 - Rev 03
Status : Withdrawn by Holder
Issue Date : 2007-09-19
Type : Chemical
Substance Number : 883
Certificate Number : R1-CEP 2000-397 - Rev 02
Status : Valid
Issue Date : 2012-07-16
Type : Chemical
Substance Number : 883
Certificate Number : R1-CEP 2008-228 - Rev 02
Status : Valid
Issue Date : 2021-08-13
Type : Chemical and TSE
Substance Number : 883
Certificate Number : CEP 1998-055 - Rev 07
Status : Valid
Issue Date : 2024-08-16
Type : Chemical
Substance Number : 883
Certificate Number : R1-CEP 2002-066 - Rev 04
Status : Withdrawn by Holder
Issue Date : 2013-02-22
Type : Chemical
Substance Number : 883
A Calcitriol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Calcitriol, including repackagers and relabelers. The FDA regulates Calcitriol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Calcitriol 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 Calcitriol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Calcitriol supplier is an individual or a company that provides Calcitriol active pharmaceutical ingredient (API) or Calcitriol finished formulations upon request. The Calcitriol suppliers may include Calcitriol API manufacturers, exporters, distributors and traders.
click here to find a list of Calcitriol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Calcitriol CEP of the European Pharmacopoeia monograph is often referred to as a Calcitriol Certificate of Suitability (COS). The purpose of a Calcitriol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Calcitriol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Calcitriol to their clients by showing that a Calcitriol CEP has been issued for it. The manufacturer submits a Calcitriol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Calcitriol CEP holder for the record. Additionally, the data presented in the Calcitriol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Calcitriol DMF.
A Calcitriol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Calcitriol 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 Calcitriol suppliers with CEP (COS) on PharmaCompass.
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