Synopsis
0
CEP/COS
0
JDMF
0
VMF
0
EDQM
0
USP
0
JP
0
Others
0
Listed Dossiers
DRUG PRODUCT COMPOSITIONS
0
API
0
Data Compilation #PharmaFlow
0
Weekly News Recap #Phispers
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
With Fermion, start the journey of your innovative API.
Registrant Name : Bayer Korea Ltd.
Registration Date : 2020-05-27
Registration Number : Su212-7-ND
Manufacturer Name : Fermion Oy
Manufacturer Address : Orioninkatu 2, Hanko FI-10900 Finland
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
About the Company : Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe Economic Development...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...
Lee Fine Chem: Advancing Innovation and Quality in Intermediates, APIs, and Dosage Forms for Superior Pharmaceutical Solutions.
About the Company : Lee Fine Chem Private Limited specializes in Advanced Intermediates, Active Pharmaceutical Ingredients (APIs), and Finished Dosage Forms. With a strong focus on quality and innovat...
Qingmu Pharma: Patients first, FDA/CEP/US-DMF/US-VMF/ASMF APIs for Humans & Vets in 100+ countries.
About the Company : Sichuan Qingmu Pharmaceutical Co., Ltd. is an innovation-driven pharmaceutical company focused on regulated markets. We specialize in the R&D and manufacturing of generic APIs and ...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
Lead Product(s) : Darolutamide,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Bayer AG
Deal Size : Inapplicable
Deal Type : Inapplicable
U.S. FDA approves third indication of darolutamide for prostate cancer
Details : Nubeqa (darolutamide) is an orally available androgen receptor inhibitors, which is currently being evaluated for the treatment of metastatic hormone-sensitive prostate cancer.
Product Name : Nubeqa
Product Type : HPAPI
Upfront Cash : Inapplicable
June 03, 2025
Lead Product(s) : Darolutamide,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Bayer AG
Deal Size : Inapplicable
Deal Type : Inapplicable
Orion's Partner Bayer Submits Darolutamide Application in China for Third Indication
Details : Nubeqa (darolutamide) is an orally available androgen receptor inhibitors, which is currently being evaluated for the treatment of metastatic hormone-sensitive prostate cancer.
Product Name : Nubeqa
Product Type : HPAPI
Upfront Cash : Inapplicable
January 07, 2025
Lead Product(s) : Darolutamide,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Bayer AG
Deal Size : Inapplicable
Deal Type : Inapplicable
Orion's Partner Bayer Submits Darolutamide Application in EU for Third Indication
Details : Nubeqa (darolutamide) is an orally available androgen receptor inhibitors, which is currently being evaluated for the treatment of metastatic hormone-sensitive prostate cancer.
Product Name : Nubeqa
Product Type : HPAPI
Upfront Cash : Inapplicable
October 14, 2024
Lead Product(s) : Darolutamide,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Bayer AG
Deal Size : Inapplicable
Deal Type : Inapplicable
Bayer Seeks U.S. FDA Nod for Third Indication of Orion-Originated Darolutamide
Details : Nubeqa (darolutamide) is an orally available androgen receptor inhibitors, which is currently being evaluated for the treatment of metastatic hormone-sensitive prostate cancer.
Product Name : Nubeqa
Product Type : HPAPI
Upfront Cash : Inapplicable
September 26, 2024
Lead Product(s) : Darolutamide,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Bayer AG
Deal Size : Inapplicable
Deal Type : Inapplicable
Phase III ARANOTE Trial in Prostate Cancer Meets Primary Endpoint
Details : Nubeqa (darolutamide) is an orally available androgen receptor inhibitors, which is currently being evaluated for the treatment of metastatic hormone-sensitive prostate cancer.
Product Name : Nubeqa
Product Type : HPAPI
Upfront Cash : Inapplicable
July 17, 2024
Lead Product(s) : Darolutamide,Docetaxel
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Bayer AG
Deal Size : Inapplicable
Deal Type : Inapplicable
Orion and Bayer Expand Clinical Development Program for Darolutamide in Prostate Cancer
Details : Nubeqa (darolutamide) is an oral androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of pros...
Product Name : Nubeqa
Product Type : HPAPI
Upfront Cash : Inapplicable
March 23, 2023
Lead Product(s) : Darolutamide,Docetaxel
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Darolutamide Approved for Additional Prostate Cancer Indication in China
Details : Nubeqa (darolutamide) is an oral androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of pros...
Product Name : Nubeqa
Product Type : HPAPI
Upfront Cash : Inapplicable
March 20, 2023
Lead Product(s) : Darolutamide,Docetaxel
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Bayer AG
Deal Size : Inapplicable
Deal Type : Inapplicable
Darolutamide Receives Approval for Additional Prostate Cancer Indication in Japan
Details : Nubeqa (darolutamide) is an oral androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of pros...
Product Name : Nubeqa
Product Type : HPAPI
Upfront Cash : Inapplicable
February 27, 2023
Lead Product(s) : Darolutamide,Docetaxel
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Nubeqa (darolutamide) is an oral androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of pros...
Product Name : Nubeqa
Product Type : HPAPI
Upfront Cash : Inapplicable
January 27, 2023
Lead Product(s) : Darolutamide,Docetaxel
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Darolutamide Receives EU Approval for Additional Indication in Prostate Cancer
Details : Nubeqa (darolutamide) is an oral androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of pros...
Product Name : Nubeqa
Product Type : HPAPI
Upfront Cash : Inapplicable
January 03, 2023
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
2-Chloro-4-(1H-pyrazol-5-yl) benzo nitrile
CAS Number : 1297537-37-1
End Use API : Darolutamide
About The Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, c...
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
2-chloro-4-(1H-pyrazol-5-yl)benzonitrile
CAS Number : 1297537-37-1
End Use API : Darolutamide
About The Company : Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe ...
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
CAS Number : 154607-01-9
End Use API : Darolutamide
About The Company : Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe ...
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
N-(tert-Butoxycarbonyl)-L-alaninol
CAS Number : 79069-13-9
End Use API : Darolutamide
About The Company : Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe ...
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
5-Acetyl-1H-pyrazole-3-carboxylic acid
CAS Number : 949034-45-1
End Use API : Darolutamide
About The Company : Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe ...
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
1H-Pyrazole-3-carboxylic acid, 5-(acetylamino)
CAS Number : 949034-45-1
End Use API : Darolutamide
About The Company : Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe ...
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
2-chloro-4-(1-(tetrahydro-2H-pyran-2-yl)-1H-pyrazo...
CAS Number : 1297537-35-9
End Use API : Darolutamide
About The Company : Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe ...
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
(S)-4-(1-(2-aminopropyl)-1H-pyrazol-3-yl)-2- chlor...
CAS Number : 1297537-41-7
End Use API : Darolutamide
About The Company : Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe ...
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
(S)-5-acetyl-N-(1-(3-(3-chloro-4-cyanophenyl)-1H- ...
CAS Number : 1297537-33-7
End Use API : Darolutamide
About The Company : Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe ...
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
1-(Tetrahydro-2H-pyran-2-yl)-1H-pyrazole-5-boronic...
CAS Number : 903550-26-5
End Use API : Darolutamide
About The Company : Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe ...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Digital Content
STOCK RECAP #PipelineProspector
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
US Patents
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
84
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.
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.
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.
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.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Darolutamide Drug Master File in Korea (Darolutamide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Darolutamide. The MFDS reviews the Darolutamide KDMF as part of the drug registration process and uses the information provided in the Darolutamide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Darolutamide 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 Darolutamide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Darolutamide suppliers with KDMF on PharmaCompass.
A Darolutamide written confirmation (Darolutamide WC) is an official document issued by a regulatory agency to a Darolutamide manufacturer, verifying that the manufacturing facility of a Darolutamide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Darolutamide APIs or Darolutamide finished pharmaceutical products to another nation, regulatory agencies frequently require a Darolutamide WC (written confirmation) as part of the regulatory process.
click here to find a list of Darolutamide suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Darolutamide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Darolutamide API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Darolutamide as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Darolutamide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Darolutamide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Darolutamide suppliers with NDC on PharmaCompass.
Darolutamide Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Darolutamide GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Darolutamide GMP manufacturer or Darolutamide GMP API supplier for your needs.
A Darolutamide CoA (Certificate of Analysis) is a formal document that attests to Darolutamide's compliance with Darolutamide specifications and serves as a tool for batch-level quality control.
Darolutamide CoA mostly includes findings from lab analyses of a specific batch. For each Darolutamide CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Darolutamide may be tested according to a variety of international standards, such as European Pharmacopoeia (Darolutamide EP), Darolutamide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Darolutamide USP).
