Axplora- The partner of choice for complex APIs.
01 1Axplora
02 1LGM Pharma
03 1Temad Co
04 1TAPI Technology & API Services
05 3Bayer AG
06 1Cipla
07 1Curia
08 2Hubei Gedian Humanwell Pharmaceutical
09 1JIANGSU GRAND XIANLE PHARMACEUTICAL CO LTD
10 1NEWCHEM SPA
11 1Sicor de Mexico
12 1Swati Spentose
13 1Teva Pharmaceutical Industries
14 1Unipex
15 2Zhejiang Xianju Pharmaceutical Co. Ltd
01 5China
02 1France
03 4Germany
04 2India
05 1Iran
06 2Israel
07 1Italy
08 1Mexico
09 2U.S.A
01 1Active
02 5Inactive
03 13Blank
01 10Valid
02 2Withdrawn by Holder
03 7Blank
01 19Blank
01 1WC-0140
02 18Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18043
Submission : 2005-02-01
Status : Active
Type : II
Certificate Number : R0-CEP 2018-270 - Rev 00
Issue Date : 2020-08-03
Type : Chemical
Substance Number : 1094
Status : Valid
NDC Package Code : 46439-8720
Start Marketing Date : 1998-05-15
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14078
Submission : 1999-04-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20182
Submission : 2007-04-24
Status : Inactive
Type : II
Certificate Number : R1-CEP 2007-038 - Rev 03
Issue Date : 2019-03-25
Type : Chemical
Substance Number : 1094
Status : Valid
Date of Issue : 2022-06-03
Valid Till : 2025-07-02
Written Confirmation Number : WC-0140
Address of the Firm :
NDC Package Code : 53104-7635
Start Marketing Date : 2016-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 677
Submission : 1963-09-27
Status : Inactive
Type : II
Certificate Number : R1-CEP 1999-102 - Rev 04
Issue Date : 2017-03-03
Type : Chemical
Substance Number : 1094
Status : Valid
Registrant Name : Bayer Korea Ltd.
Registration Date : 2021-08-10
Registration Number : 20210810-209-J-1087
Manufacturer Name : Bayer AG@Bayer AG
Manufacturer Address : Ernst-Schering-Straβe 14, 59192 Bergkamen, Germany@Max-Dohrn-Straβe 8, Drug Substance Finishing Plant, Werk Charlottenburg 10589 Berlin, Germany
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2043
Submission : 1973-02-01
Status : Inactive
Type : II
Certificate Number : R1-CEP 2005-168 - Rev 01
Issue Date : 2017-03-03
Type : Chemical
Substance Number : 1094
Status : Valid
Registrant Name : Bayer Korea Ltd.
Registration Date : 2021-08-10
Registration Number : 20210810-209-J-1087
Manufacturer Name : Bayer AG@Bayer AG
Manufacturer Address : Ernst-Schering-Straβe 14, 59192 Bergkamen, Germany@Max-Dohrn-Straβe 8, Drug Substance Finishing Plant, Werk Charlottenburg 10589 Berlin, Germany
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5168
Submission : 1983-12-20
Status : Inactive
Type : II
Registrant Name : Bayer Korea Ltd.
Registration Date : 2021-08-10
Registration Number : 20210810-209-J-1087
Manufacturer Name : Bayer AG@Bayer AG
Manufacturer Address : Ernst-Schering-Straβe 14, 59192 Bergkamen, Germany@Max-Dohrn-Straβe 8, Drug Substance Finishing Plant, Werk Charlottenburg 10589 Berlin, Germany
Certificate Number : CEP 2023-187 - Rev 00
Issue Date : 2023-09-15
Type : Chemical
Substance Number : 1094
Status : Valid
A Cyproterone Acetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cyproterone Acetate, including repackagers and relabelers. The FDA regulates Cyproterone Acetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cyproterone Acetate 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 Cyproterone Acetate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cyproterone Acetate supplier is an individual or a company that provides Cyproterone Acetate active pharmaceutical ingredient (API) or Cyproterone Acetate finished formulations upon request. The Cyproterone Acetate suppliers may include Cyproterone Acetate API manufacturers, exporters, distributors and traders.
click here to find a list of Cyproterone Acetate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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