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
02 1LGM Pharma
03 1Supriya Lifescience
04 1Capital Farma
05 1Kinsy SL
06 1Almelo
07 1Bayer AG
08 1Beijing Beilu Pharma
09 1BrightGene Bio-Medical Technology Co.,Ltd
10 1Divis Laboratories
11 1Dongkook Lifescience
12 1Estechpharma
13 1Farmak JSC
14 1Formosa Laboratories
15 1Guangzhou Tosun Pharmaceutical
16 1Hainan Poly Pharm
17 1JRC
18 1Jiangsu Hengrui Medicine
19 1MSN Laboratories
20 1ST Pharma
21 1Seven Star Pharmaceutical
22 1Sichuan Qingmu Pharmaceutical
23 1Sichuan Renan Pharmaceutical
24 2Sionc Pharmaceuticals
25 1Viwit Pharmaceuticals Limited
26 1Yangtze River Pharmaceutical Group
27 1Blank
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01 9China
02 1Germany
03 8India
04 3South Korea
05 2Spain
06 2Taiwan
07 1U.S.A
08 1Ukraine
09 1Blank
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01 10Active
02 18Blank
01 7Valid
02 21Blank
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01 1305MF10082
02 27Blank
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01 1WC-0273
02 1WC-0273A7
03 26Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-08-04
Pay. Date : 2020-06-23
DMF Number : 33420
Submission : 2019-09-10
Status : Active
Type : II
Certificate Number : R0-CEP 2019-307 - Rev 01
Issue Date : 2023-06-08
Type : Chemical
Substance Number : 2735
Status : Valid
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Capital Farma, a leading European pharmaceutical company focusing on the development & distribution of niche APIs & Pharma Services.
Reliable Spanish CDMO Delivering High-Quality APIs and Intermediates with Excellence, Flexibility, and Regulatory Compliance.
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-03-30
Pay. Date : 2021-02-26
DMF Number : 35662
Submission : 2021-02-26
Status : Active
Type : II
Certificate Number : R0-CEP 2020-015 - Rev 01
Issue Date : 2022-11-28
Type : Chemical
Substance Number : 2735
Status : Valid
NDC Package Code : 73675-002
Start Marketing Date : 2023-09-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Estifarm Co., Ltd.
Registration Date : 2018-07-10
Registration Number : 1301-7-ND
Manufacturer Name : Estifarm Co., Ltd.
Manufacturer Address : 171 Haean-ro, Danwon-gu, Ansan-si, Gyeonggi-do
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-08-09
Pay. Date : 2024-07-25
DMF Number : 39094
Submission : 2023-11-24
Status : Active
Type : II
Certificate Number : CEP 2023-442 - Rev 01
Issue Date : 2025-01-21
Type : Chemical
Substance Number : 2735
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40533
Submission : 2024-09-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38579
Submission : 2023-08-18
Status : Active
Type : II
Certificate Number : CEP 2024-313 - Rev 00
Issue Date : 2025-01-09
Type : Chemical
Substance Number : 2735
Status : Valid
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-09-25
Pay. Date : 2023-08-29
DMF Number : 36996
Submission : 2022-03-31
Status : Active
Type : II
NDC Package Code : 72640-022
Start Marketing Date : 2022-03-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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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, Price,and more, enabling you to easily find the right Gadobutrol manufacturer or Gadobutrol supplier for your needs.
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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.
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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.
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We have 26 companies offering Gadobutrol
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