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Gonane Estradiol Gonane Estradiol

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List of Drug Master Files (KDMF) for Estradiol Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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01 Symbiotec Pharmalab Private Limited (1)

02 Aspen Oss B.V. (2)

03 Aspen Oss BV@Aspen Oss BV (1)

04 Aspen Oss BV_x000D_ (1)

05 Bayer AG "Bergkamen" (all processes except micronization)@Bayer AG "Berlin-Charlottenburg" (micronization) (2)

06 Bayer AG "Bergkamen"@Bayer AG "Berlin-Charlottenburg" (1)

07 Pfizer Global Supply - Brandon, A Division of Pfizer Canada ULC (1)

08 Pfizer Ireland Pharmaceuticals (1)

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01 Abbott Korea Co., Ltd. (1)

02 Bayer Korea Co., Ltd. (1)

03 Hyundai Pharmaceutical Co., Ltd. (1)

04 Korea Organon Co., Ltd. (1)

05 Myungmoon Pharmaceutical Co., Ltd. (1)

06 Narsha Farm Co., Ltd. (1)

07 Pfizer Pharmaceuticals Korea Co., Ltd. (2)

08 Sinex Co., Ltd. (2)

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01 Conjugated estrogen 4.29% (2)

02 Estradiol hemihydrate (6)

03 Estradiol hemihydrate (micronized) (1)

04 estradiol (1)

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01 Germany (3)

02 India (1)

03 Netherlands (4)

04 U.S.A (2)

Narsha Farm Co., Ltd.
2022-12-22
20221222-181-I-649-08
Symbiotec Pharmalab Priva...
India
Plot No: 5, 6, 7 & 8, Spe...
Sinex Co., Ltd.
2022-01-13
20121221-181-I-217-02(A)
Aspen Oss B.V.
Netherlands
Veersemeer 4, Oss, 5347 J...
Korea Organon Co., Ltd.
2012-11-02
20121102-181-I-30-01
Aspen Oss BV_x000D_
Netherlands
Veersemeer 4 5347 JN, Oss
Sinex Co., Ltd.
2022-01-13
20220113-181-I-637-06
Aspen Oss BV@Aspen Oss BV
Netherlands
Kloosterstraat 6, Oss, 53...
Abbott Korea Co., Ltd.
2012-12-21
20121221-181-I-217-02
Aspen Oss B.V.
Netherlands
Veersemeer 4, 5347 JN Oss...
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Hyundai Pharmaceutical Co., Ltd.
2020-04-01
20121228-181-I-166-03(2)
Bayer AG "Bergkamen"@Baye...
Germany
Ernst-Schering-Straße 14...
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Myungmoon Pharmaceutical Co., Ltd.
2014-06-19
20121228-181-I-166-03(1)
Bayer AG "Bergkamen" (all...
Germany
Ernst-Schering-Straße 14...
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Bayer Korea Co., Ltd.
2012-12-28
20121228-181-I-166-03
Bayer AG "Bergkamen" (all...
Germany
Ernst-Schering-Straße 14...
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Pfizer Pharmaceuticals Korea Co., Ltd.
2021-06-04
20210604-209-J-1009
Pfizer Global Supply - Br...
Canada
720 17th Street East, Bra...
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Pfizer Pharmaceuticals Korea Co., Ltd.
2021-06-03
20210603-209-J-1006
Pfizer Ireland Pharmaceut...
Ireland
Little Connell, Newbridge...
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Looking for 50-28-2 / Estradiol API manufacturers, exporters & distributors?

Estradiol manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Estradiol 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 Estradiol manufacturer or Estradiol supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Estradiol manufacturer or Estradiol supplier.

PharmaCompass also assists you with knowing the Estradiol API Price utilized in the formulation of products. Estradiol API Price is not always fixed or binding as the Estradiol Price is obtained through a variety of data sources. The Estradiol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Estradiol

Synonyms

Beta-estradiol, 17beta-estradiol, 50-28-2, Oestradiol, Dihydrofolliculin, Estrace

Cas Number

50-28-2

Unique Ingredient Identifier (UNII)

4TI98Z838E

About Estradiol

The 17-beta-isomer of estradiol, an aromatized C18 steroid with hydroxyl group at 3-beta- and 17-beta-position. Estradiol-17-beta is the most potent form of mammalian estrogenic steroids.

Estradiol Manufacturers

A Estradiol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Estradiol, including repackagers and relabelers. The FDA regulates Estradiol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Estradiol 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 Estradiol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Estradiol Suppliers

A Estradiol supplier is an individual or a company that provides Estradiol active pharmaceutical ingredient (API) or Estradiol finished formulations upon request. The Estradiol suppliers may include Estradiol API manufacturers, exporters, distributors and traders.

click here to find a list of Estradiol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Estradiol KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Estradiol Drug Master File in Korea (Estradiol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Estradiol. The MFDS reviews the Estradiol KDMF as part of the drug registration process and uses the information provided in the Estradiol KDMF to evaluate the safety and efficacy of the drug.

After submitting a Estradiol 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 Estradiol API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Estradiol suppliers with KDMF on PharmaCompass.

Estradiol Manufacturers | Traders | Suppliers

Estradiol Manufacturers, Traders, Suppliers 1
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We have 4 companies offering Estradiol

Get in contact with the supplier of your choice:

  1. Aspen API
  2. Symbiotec Pharmalab
  3. Bayer AG
  4. Pfizer Inc
Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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