Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1BIOPHORE INDIA PHARMACEUTICALS PVT. LTD. Hyderabad IN
02 2VIWIT PHARMACEUTICAL CO. LTD Tengzhou CN
03 1BAYER AG Leverkusen DE
04 1ANHUI POLY PHARM. CO., LTD. Anqing CN
05 1BEIJING BEILU PHARMACEUTICAL CO., LTD. Beijing CN
06 1MSN LIFE SCIENCES PRIVATE LIMITED Bhiknoor Village IN
07 1SICHUAN RENAN PHARMACEUTICAL CO., LTD. Yuechi CN
08 1ST PHARM CO., LTD. Ansan-Si KR
09 1SUZHOU MEDINOAH LTD. Suzhou CN
10 1WEINAN MANARECO PHARMACEUTICAL CO., LTD. Weinan CN
01 10Gadobutrol monohydrate
02 1Gadobutrol monohydrate, Process 2
01 4China
02 1Germany
03 2India
04 1South Korea
05 3Blank
01 11Valid
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
Viwit Pharmaceuticals is a global provider of APIs, specialty generics, borane compounds, and CDMO services.
Viwit Pharmaceuticals is a global provider of APIs, specialty generics, borane compounds, and CDMO services.
Certificate Number : CEP 2023-442 - Rev 01
Status : Valid
Issue Date : 2025-01-21
Type : Chemical
Substance Number : 2735
Bayer AG manufactures innovative APIs and pharmaceutical formulations across diverse therapeutic areas.
Bayer AG manufactures innovative APIs and pharmaceutical formulations across diverse therapeutic areas.
Certificate Number : CEP 2017-275 - Rev 02
Status : Valid
Issue Date : 2023-12-06
Type : Chemical
Substance Number : 2735
Viwit Pharmaceuticals is a global provider of APIs, specialty generics, borane compounds, and CDMO services.
Viwit Pharmaceuticals is a global provider of APIs, specialty generics, borane compounds, and CDMO services.
Gadobutrol Monohydrate, Process 2
Certificate Number : CEP 2025-342 - Rev 00
Status : Valid
Issue Date : 2025-08-19
Type : Chemical
Substance Number : 2735
Certificate Number : CEP 2025-019 - Rev 00
Status : Valid
Issue Date : 2026-05-27
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 2023-260 - Rev 00
Status : Valid
Issue Date : 2025-06-25
Type : Chemical
Substance Number : 2735
Certificate Number : CEP 2024-313 - Rev 00
Status : Valid
Issue Date : 2025-01-09
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
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Certificate Number : CEP 2024-388 - Rev 00
Status : Valid
Issue Date : 2025-07-29
Type : Chemical
Substance Number : 2735
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Product Web Link
Virtual Booth
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PharmaCompass offers a list of Gadobutrol API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Gadobutrol manufacturer or Gadobutrol supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Gadobutrol manufacturer or Gadobutrol supplier.
A Gadovist manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gadovist, including repackagers and relabelers. The FDA regulates Gadovist manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gadovist 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 Gadovist manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Gadovist supplier is an individual or a company that provides Gadovist active pharmaceutical ingredient (API) or Gadovist finished formulations upon request. The Gadovist suppliers may include Gadovist API manufacturers, exporters, distributors and traders.
click here to find a list of Gadovist suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Gadovist CEP of the European Pharmacopoeia monograph is often referred to as a Gadovist Certificate of Suitability (COS). The purpose of a Gadovist CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Gadovist EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Gadovist to their clients by showing that a Gadovist CEP has been issued for it. The manufacturer submits a Gadovist CEP (COS) as part of the market authorization procedure, and it takes on the role of a Gadovist CEP holder for the record. Additionally, the data presented in the Gadovist CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Gadovist DMF.
A Gadovist CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Gadovist 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 Gadovist suppliers with CEP (COS) on PharmaCompass.
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