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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 39560

Submission : 2024-04-04

Status : Active

Type : II

Polpharma CB

02

ICHH-25
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 35618

Submission : 2021-04-28

Status : Active

Type : II

Aarti Industries Company Banner

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

GDUFA

DMF Review : Complete

Rev. Date : 2015-06-11

Pay. Date : 2014-12-30

DMF Number : 29117

Submission : 2015-03-31

Status : Active

Type : II

Dr Reddy Company Banner

09

ICHH-25
Not Confirmed

Looking for 915087-33-1 / Enzalutamide API manufacturers, exporters & distributors?

Enzalutamide manufacturers, exporters & distributors 1

43

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 USDMF

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

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

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

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.