Bayer AG manufactures innovative APIs and pharmaceutical formulations across diverse therapeutic areas.

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01 2Bayer AG
02 1ALP Pharm
03 1BrightGene Bio-Medical Technology Co.,Ltd
04 1Brother Enterprises Holding
05 1Daewoong Pharmaceutical
06 1Divis Laboratories
07 1JRC
08 1Sichuan Renan Pharmaceutical
09 1Suzhou Ryway Biotech
10 1Zhejiang Starry Pharmaceutical Co., Ltd
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01 6China
02 2Germany
03 2India
04 1South Korea
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01 3Active
02 2Inactive
03 6Blank
01 3Valid
02 8Blank
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01 11Blank
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01 1WC-0031
02 10Blank
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01 120180706-210-J-240
02 120260415-210-J-2176
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Bayer AG manufactures innovative APIs and pharmaceutical formulations across diverse therapeutic areas.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8178
Submission : 1989-08-15
Status : Active
Type : II
Certificate Number : CEP 2020-273 - Rev 01
Issue Date : 2025-10-31
Type : Chemical
Substance Number : 1753
Status : Valid
Registrant Name : Bayer Korea Co., Ltd.
Registration Date : 2018-07-06
Registration Number : 20180706-210-J-240
Manufacturer Name : Bayer AG
Manufacturer Address : Ernst-Schering-Straße 14 59192 Bergkamen Germany
Bayer AG manufactures innovative APIs and pharmaceutical formulations across diverse therapeutic areas.
Certificate Number : R1-CEP 2015-172 - Rev 00
Issue Date : 2022-01-31
Type : Chemical
Substance Number : 1753
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 42381
Submission : 2025-08-04
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35356
Submission : 2020-12-04
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38239
Submission : 2023-04-09
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25680
Submission : 2012-01-05
Status : Inactive
Type : II

Certificate Number : CEP 2022-232 - Rev 01
Issue Date : 2025-05-02
Type : Chemical
Substance Number : 1753
Status : Valid


Date of Issue : 2025-06-13
Valid Till : 2028-06-16
Written Confirmation Number : WC-0031
Address of the Firm :
Registrant Name : Bayer Korea Co., Ltd.
Registration Date : 2026-04-15
Registration Number : 20260415-210-J-2176
Manufacturer Name : Divi's Laboratories Limited (Unit I)
Manufacturer Address : Lingojigudem Village, Choutuppal Mandal Yadadri Bhuvanagiri District, Telangana 508252, India


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A Ultravist 300 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ultravist 300, including repackagers and relabelers. The FDA regulates Ultravist 300 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ultravist 300 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 Ultravist 300 supplier is an individual or a company that provides Ultravist 300 active pharmaceutical ingredient (API) or Ultravist 300 finished formulations upon request. The Ultravist 300 suppliers may include Ultravist 300 API manufacturers, exporters, distributors and traders.
click here to find a list of Ultravist 300 suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
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