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List of Drug Master Files (DMF) of Darolutamide Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Alembic Pharmaceuticals Limited (1)

02 Hetero Drugs (1)

03 MSN Laboratories (2)

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01 DAROLUTAMIDE (3)

02 DAROLUTAMIDE PREMIX (1)

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01 India (4)

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01 Active (4)

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01 Complete (3)

02 Blank (1)

URL Supplier Web Content
37912
Active
2023-03-30
Complete
2023-04-20
2023-03-30
II
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URL Supplier Web Content
38274
Active
2023-05-02
Complete
2023-06-13
2023-04-25
II
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URL Supplier Web Content
37585
Active
2022-11-30
Complete
2023-01-30
2023-01-09
II
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URL Supplier Web Content
36697
Active
2022-02-28
N/A
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Looking for 1297538-32-9 / Darolutamide API manufacturers, exporters & distributors?

Darolutamide manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Darolutamide

Synonyms

Odm-201, 1297538-32-9, Bay-1841788, Nubeqa, Bay1841788, Darolutamide [usan]

Cas Number

1297538-32-9

Unique Ingredient Identifier (UNII)

X05U0N2RCO

About Darolutamide

Darolutamide is a formulation containing an androgen receptor (AR) antagonist with potential antineoplastic activity. Darolutamide binds to ARs in target tissues; subsequently, inhibiting androgen-induced receptor activation and facilitating the formation of inactive complexes that cannot translocate to the nucleus. This prevents binding to and transcription of AR-responsive genes that regulate prostate cancer cell proliferation. This ultimately leads to an inhibition of growth in AR-expressing prostate cancer cells.

Darolutamide Manufacturers

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

Darolutamide Suppliers

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

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

Darolutamide USDMF

A Darolutamide DMF (Drug Master File) is a document detailing the whole manufacturing process of Darolutamide active pharmaceutical ingredient (API) in detail. Different forms of Darolutamide DMFs exist exist since differing nations have different regulations, such as Darolutamide USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Darolutamide DMF submitted to regulatory agencies in the US is known as a USDMF. Darolutamide USDMF includes data on Darolutamide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Darolutamide USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Darolutamide suppliers with USDMF on PharmaCompass.

Darolutamide Manufacturers | Traders | Suppliers

Darolutamide Manufacturers, Traders, Suppliers 1
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We have 3 companies offering Darolutamide

Get in contact with the supplier of your choice:

  1. Alembic Pharmaceuticals Limited
  2. Hetero Drugs
  3. 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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