Aspen API. More than just an API.
01 1ASPEN OSS B.V. Oss NL
02 1Industriale Chimica S.R.L. Saronno IT
03 1LIBBS FARMACEUTICA LTDA. Embu das Artes BR
04 1NEWCHEM S.p.A. Milano IT
05 1QINHUANGDAO ZIZHU PHARMACEUTICAL CO., LTD. Qinhuangdao City CN
06 1SYMBIOTICA SPECIALITY INGREDIENTS SDN. BHD. Perai MY
07 1ZHEJIANG XIANJU JUNYE PHARMACEUTICAL CO., LTD. Xianju CN
01 7Tibolone
01 1Brazil
02 2China
03 2Italy
04 1Malaysia
05 1Netherlands
01 6Valid
02 1Withdrawn by Holder
Aspen API. More than just an API.
Aspen API. More than just an API.
Certificate Number : R1-CEP 2012-173 - Rev 03
Status : Valid
Issue Date : 2022-11-25
Type : Chemical
Substance Number : 1739
Certificate Number : R1-CEP 2009-336 - Rev 00
Status : Valid
Issue Date : 2015-07-10
Type : Chemical
Substance Number : 1739
Certificate Number : R1-CEP 2011-124 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2017-07-13
Type : Chemical
Substance Number : 1739
Certificate Number : R1-CEP 2012-329 - Rev 02
Status : Valid
Issue Date : 2023-07-20
Type : Chemical
Substance Number : 1739
Certificate Number : R1-CEP 2015-015 - Rev 00
Status : Valid
Issue Date : 2021-02-11
Type : Chemical
Substance Number : 1739
Certificate Number : R1-CEP 2010-294 - Rev 00
Status : Valid
Issue Date : 2016-12-14
Type : Chemical
Substance Number : 1739
Certificate Number : R1-CEP 2012-142 - Rev 01
Status : Valid
Issue Date : 2018-04-11
Type : Chemical
Substance Number : 1739
A Tibolone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tibolone, including repackagers and relabelers. The FDA regulates Tibolone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tibolone 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 Tibolone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tibolone supplier is an individual or a company that provides Tibolone active pharmaceutical ingredient (API) or Tibolone finished formulations upon request. The Tibolone suppliers may include Tibolone API manufacturers, exporters, distributors and traders.
click here to find a list of Tibolone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tibolone CEP of the European Pharmacopoeia monograph is often referred to as a Tibolone Certificate of Suitability (COS). The purpose of a Tibolone CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Tibolone EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Tibolone to their clients by showing that a Tibolone CEP has been issued for it. The manufacturer submits a Tibolone CEP (COS) as part of the market authorization procedure, and it takes on the role of a Tibolone CEP holder for the record. Additionally, the data presented in the Tibolone CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Tibolone DMF.
A Tibolone CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Tibolone 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 Tibolone suppliers with CEP (COS) on PharmaCompass.
We have 7 companies offering Tibolone
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