Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
01 1Symbiotec Pharmalab Private Limited
02 2Aspen Oss BV
03 1Aspen Oss BV@Aspen Oss BV
04 1Aspen Oss BV_x000D_
05 2Bayer AG "Bergkamen" (all processes except differentiation)@Bayer AG "Berlin-Charlottenburg" (differentiation)
06 1Bayer AG "Bergkamen"@Bayer AG "Berlin-Charlottenburg"
07 1Pfizer Global Supply - Brandon, A Division of Pfizer Canada ULC
08 1Pfizer Ireland Pharmaceuticals
01 1Abbott Korea Ltd.
02 1Bayer Korea Ltd.
03 1Hyundai Pharmaceutical Co., Ltd.
04 1Korea Organon Co., Ltd.
05 2Korea Pfizer Pharmaceutical Co., Ltd.
06 1Myungmoon Pharmaceutical Co., Ltd.
07 1Narsha Farm Co., Ltd.
08 2Synex Co., Ltd.
01 2Conjugated estrogen 4.29%
02 1Estradiol
03 4Estradiol hemihydrate
04 3Estradiol hemihydrate (micronized)
01 3Germany
02 1India
03 4Netherlands
04 2U.S.A
Registrant Name : Narsha Farm Co., Ltd.
Registration Date : 2022-12-22
Registration Number : 20221222-181-I-649-08
Manufacturer Name : Symbiotec Pharmalab Private ...
Manufacturer Address : Plot No: 5, 6, 7 & 8, Special Economic Zone, Phase-II, Pharma zone, Pithampur, Dist. ...
Estradiol hemihydrate (micronized)
Registrant Name : Synex Co., Ltd.
Registration Date : 2022-01-13
Registration Number : 20121221-181-I-217-02(A)
Manufacturer Name : Aspen Oss BV
Manufacturer Address : Veersemeer 4, Oss, 5347 JN, The Netherlands
Registrant Name : Abbott Korea Ltd.
Registration Date : 2012-12-21
Registration Number : 20121221-181-I-217-02
Manufacturer Name : Aspen Oss BV
Manufacturer Address : Veersemeer 4, 5347 JN Oss, The Netherlands
Estradiol hemihydrate (micronized)
Registrant Name : Synex Co., Ltd.
Registration Date : 2022-01-13
Registration Number : 20220113-181-I-637-06
Manufacturer Name : Aspen Oss BV@Aspen Oss BV
Manufacturer Address : Kloosterstraat 6, Oss, 5349 AB, The Netherlands@Veersemeer 4, Oss, 5347 JN, The Nethe...
Registrant Name : Korea Organon Co., Ltd.
Registration Date : 2012-11-02
Registration Number : 20121102-181-I-30-01
Manufacturer Name : Aspen Oss BV_x000D_
Manufacturer Address : Veersemeer 4 5347 JN, Oss
Registrant Name : Myungmoon Pharmaceutical Co., Ltd.
Registration Date : 2014-06-19
Registration Number : 20121228-181-I-166-03(1)
Manufacturer Name : Bayer AG "Bergkamen" (all pr...
Manufacturer Address : Ernst-Schering-Straße 14, 59192 Bergkamen, Germany@Max-Dohrn-Straße 8, 10589 Berlin...
Estradiol hemihydrate (micronized)
Registrant Name : Bayer Korea Ltd.
Registration Date : 2012-12-28
Registration Number : 20121228-181-I-166-03
Manufacturer Name : Bayer AG "Bergkamen" (all pr...
Manufacturer Address : Ernst-Schering-Straße 14, 59192 Bergkamen, Germany@Max-Dohrn-Straße 8, 10589 Berlin...
Registrant Name : Hyundai Pharmaceutical Co., Ltd.
Registration Date : 2020-04-01
Registration Number : 20121228-181-I-166-03(2)
Manufacturer Name : Bayer AG "Bergkamen"@Bayer A...
Manufacturer Address : Ernst-Schering-Straße 14, 59192 Bergkamen, Germany@Max-Dohrn-Straße 8, 10589 Berlin...
Registrant Name : Korea Pfizer Pharmaceutical Co., Ltd.
Registration Date : 2021-06-04
Registration Number : 20210604-209-J-1009
Manufacturer Name : Pfizer Global Supply - Brand...
Manufacturer Address : 720 17th Street East, Brandon Manitoba, Canada, R7A 7H2
Registrant Name : Korea Pfizer Pharmaceutical Co., Ltd.
Registration Date : 2021-06-03
Registration Number : 20210603-209-J-1006
Manufacturer Name : Pfizer Ireland Pharmaceutica...
Manufacturer Address : Little Connell, Newbridge, Co Kildare Ireland
A Estrogens, esterified manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Estrogens, esterified, including repackagers and relabelers. The FDA regulates Estrogens, esterified manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Estrogens, esterified 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 Estrogens, esterified manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Estrogens, esterified supplier is an individual or a company that provides Estrogens, esterified active pharmaceutical ingredient (API) or Estrogens, esterified finished formulations upon request. The Estrogens, esterified suppliers may include Estrogens, esterified API manufacturers, exporters, distributors and traders.
click here to find a list of Estrogens, esterified suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Estrogens, esterified Drug Master File in Korea (Estrogens, esterified KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Estrogens, esterified. The MFDS reviews the Estrogens, esterified KDMF as part of the drug registration process and uses the information provided in the Estrogens, esterified KDMF to evaluate the safety and efficacy of the drug.
After submitting a Estrogens, esterified KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Estrogens, esterified API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Estrogens, esterified suppliers with KDMF on PharmaCompass.
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