Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
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01 1BIOPHORE INDIA PHARMACEUTICALS PVT. LTD. Hyderabad IN
02 1ANHUI POLY PHARM. CO., LTD. Anqing CN
03 1BAYER AG Leverkusen DE
04 1SICHUAN RENAN PHARMACEUTICAL CO., LTD. Yuechi CN
05 1ST PHARM CO., LTD. Ansan-Si KR
06 1SUZHOU MEDINOAH LTD. Suzhou CN
07 1VIWIT PHARMACEUTICAL CO. LTD Tengzhou CN
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01 7Gadobutrol monohydrate
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01 3China
02 1Germany
03 1India
04 1South Korea
05 1Blank
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01 7Valid
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
Certificate Number : R0-CEP 2019-307 - Rev 01
Status : Valid
Issue Date : 2023-06-08
Type : Chemical
Substance Number : 2735
Certificate Number : CEP 2017-275 - Rev 02
Status : Valid
Issue Date : 2023-12-06
Type : Chemical
Substance Number : 2735
Certificate Number : CEP 2024-082 - Rev 00
Status : Valid
Issue Date : 2024-11-15
Type : Chemical
Substance Number : 2735
Certificate Number : CEP 2024-313 - Rev 00
Status : Valid
Issue Date : 2025-01-09
Type : Chemical
Substance Number : 2735
Certificate Number : R0-CEP 2020-015 - Rev 01
Status : Valid
Issue Date : 2022-11-28
Type : Chemical
Substance Number : 2735
Certificate Number : CEP 2023-442 - Rev 01
Status : Valid
Issue Date : 2025-01-21
Type : Chemical
Substance Number : 2735
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Certificate Number : CEP 2024-153 - Rev 00
Status : Valid
Issue Date : 2025-01-14
Type : Chemical
Substance Number : 2735
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Gadobutrol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gadobutrol, including repackagers and relabelers. The FDA regulates Gadobutrol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gadobutrol 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 Gadobutrol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gadobutrol supplier is an individual or a company that provides Gadobutrol active pharmaceutical ingredient (API) or Gadobutrol finished formulations upon request. The Gadobutrol suppliers may include Gadobutrol API manufacturers, exporters, distributors and traders.
click here to find a list of Gadobutrol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gadobutrol CEP of the European Pharmacopoeia monograph is often referred to as a Gadobutrol Certificate of Suitability (COS). The purpose of a Gadobutrol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Gadobutrol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Gadobutrol to their clients by showing that a Gadobutrol CEP has been issued for it. The manufacturer submits a Gadobutrol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Gadobutrol CEP holder for the record. Additionally, the data presented in the Gadobutrol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Gadobutrol DMF.
A Gadobutrol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Gadobutrol 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 Gadobutrol suppliers with CEP (COS) on PharmaCompass.
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