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Midas Enzalutamide Midas Enzalutamide

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

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01 Dr. Reddy's Laboratories Limited (1)

02 Curia New York, Inc. (1)

03 Hetero Labs Limited (Unit-I) (1)

04 Laurus Labs Limited (1)

05 Laurus Labs Limited (Unit 1) (1)

06 MSN Laboratories Private Limited (1)

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01 Aging Life Science Co., Ltd. (1)

02 Alvogen Korea Co., Ltd. (1)

03 Classia Co., Ltd. (1)

04 Farmirae Co., Ltd. (1)

05 Korea Astellas Pharmaceutical Co., Ltd. (1)

06 Mpeak Korea Co., Ltd. (1)

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01 Enzalutamide (6)

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01 India (5)

02 U.S.A (1)

Farmirae Co., Ltd.
2022-05-09
Number 574-21-ND
Dr. Reddy's Laboratories ...
India
CTO Unit-VI, APIIC Indust...
URL Supplier Web Content
Korea Astellas Pharmaceutical Co., Ltd.
2015-05-18
Number 3778-6-ND
Curia New York, Inc.
U.S.A
33 Riverside Avenue, Rens...
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Mpeak Korea Co., Ltd.
2022-12-05
Wed812-19-ND
Hetero Labs Limited (Unit...
India
Survey No.10, IDA, Gaddap...
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Classia Co., Ltd.
2021-05-20
Number 434-18-ND(1)
Laurus Labs Limited (Unit...
India
Plot No. 21, Jawaharlal N...
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Aging Life Science Co., Ltd.
2020-07-20
Number 434-18-ND
Laurus Labs Limited
India
Plot No. 21, Jawaharlal N...
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Alvogen Korea Co., Ltd.
2023-05-16
Number 522-7-ND
MSN Laboratories Private ...
India
Unit-II, Sy. No. 50, Kard...
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Looking for 915087-33-1 / Enzalutamide API manufacturers, exporters & distributors?

Enzalutamide manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Enzalutamide

Synonyms

915087-33-1, Mdv3100, Mdv-3100, 4-(3-(4-cyano-3-(trifluoromethyl)phenyl)-5,5-dimethyl-4-oxo-2-thioxoimidazolidin-1-yl)-2-fluoro-n-methylbenzamide, Mdv 3100, Enzalutamide (mdv3100)

Cas Number

915087-33-1

Unique Ingredient Identifier (UNII)

93T0T9GKNU

About Enzalutamide

Enzalutamide is an orally bioavailable, organic, non-steroidal small molecule targeting the androgen receptor (AR) with potential antineoplastic activity. Through a mechanism that is reported to be different from other approved AR antagonists, enzalutamide inhibits the activity of prostate cancer cell ARs, which may result in a reduction in prostate cancer cell proliferation and, correspondingly, a reduction in the serum prostate specific antigen (PSA) level. AR over-expression in prostate cancer represents a key mechanism associated with prostate cancer hormone resistance.

Enzalutamide Manufacturers

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

Enzalutamide Suppliers

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

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

Enzalutamide KDMF

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

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

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

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

Enzalutamide Manufacturers | Traders | Suppliers

Enzalutamide Manufacturers, Traders, Suppliers 1
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We have 5 companies offering Enzalutamide

Get in contact with the supplier of your choice:

  1. Dr. Reddy's Laboratories
  2. Curia
  3. Hetero Drugs
  4. Laurus Labs
  5. MSN Laboratories
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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