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

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01 Janssen Pharmaceuticals, Inc. (1)

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01 Korea Janssen Co., Ltd. (1)

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01 Apalutamide (1)

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01 U.S.A (1)

URL Supplier Web Content
Korea Janssen Co., Ltd.
2020-12-29
Wed81-24-ND
Janssen Pharmaceuticals, ...
U.S.A
1440 Olympic Drive, Athen...
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Looking for 956104-40-8 / Apalutamide API manufacturers, exporters & distributors?

Apalutamide manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Apalutamide

Synonyms

Arn-509, 956104-40-8, Erleada, Jnj-56021927, Arn 509, Apalutamide [inn]

Cas Number

956104-40-8

Unique Ingredient Identifier (UNII)

4T36H88UA7

About Apalutamide

Apalutamide is a small molecule and androgen receptor (AR) antagonist with potential antineoplastic activity. Apalutamide binds to AR in target tissues thereby preventing androgen-induced receptor activation and facilitating the formation of inactive complexes that cannot be translocated to the nucleus. This prevents binding to and transcription of AR-responsive genes. This ultimately inhibits the expression of genes that regulate prostate cancer cell proliferation and may lead to an inhibition of cell growth in AR-expressing tumor cells.

Apalutamide Manufacturers

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

Apalutamide Suppliers

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

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

Apalutamide KDMF

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

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

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

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

Apalutamide Manufacturers | Traders | Suppliers

Apalutamide Manufacturers, Traders, Suppliers 1
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We have 1 companies offering Apalutamide

Get in contact with the supplier of your choice:

  1. Johnson & Johnson Innovative Medicine
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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