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DRUG PRODUCT COMPOSITIONS
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Data Compilation #PharmaFlow
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API SUPPLIERS
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USDMF
Axplora is your partner of choice for complex APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14136
Submission : 1999-05-12
Status :
Type : II
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
GDUFA
DMF Review : Complete
Rev. Date : 2020-06-17
Pay. Date : 2020-06-08
DMF Number : 34923
Submission : 2020-06-09
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14703
Submission : 1999-12-20
Status :
Type : II
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Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
Date of Issue : 2024-02-20
Valid Till : 2026-12-06
Written Confirmation Number : WC-0416
Address of the Firm : Plot No. 111, SIDCO Industrial Estate, Kakkalur, Thiruvallur 602 003, Tamil Nadu...
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Axplora is your partner of choice for complex APIs.
Micronized fludrocortisone acetate
Registrant Name : Samil Pharmaceutical Co., Ltd.
Registration Date : 2021-12-02
Registration Number : 20211202-209-J-1149
Manufacturer Name : Farmabios SPA@MICROCHEM SRL
Manufacturer Address : Via Pavia 1 - 27027 Gropello Cairoli (PV), Italy@Via Turati, 2 - 29017 Fiorenzuola d'...
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API Imports and Exports
Drugs in Development
Lead Product(s) : Opevesostat,Dexamethasone,Fludrocortisone Acetate
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Merck & Co
Deal Size : $1,920.0 million
Deal Type : Licensing Agreement
Merck and Orion Mutual Option Exercise for Opevesostat in Prostate Cancer Treatment
Details : Through the license agreement, Merck will gain global rights to develop and commercialize MK-5684 (opevesostat), which is being evaluated for metastatic castration-resistant prostate cancer.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : $290.0 million
July 01, 2024
Lead Product(s) : Opevesostat,Dexamethasone,Fludrocortisone Acetate
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Merck & Co
Deal Size : Inapplicable
Deal Type : Inapplicable
Orion and MSD Initiate Two Phase 3 Trials Of ODM-208 in Prostate Cancer
Details : ODM-208/MK5684, a CYP11A1 inhibitor, is in Phase 3 trials for metastatic castration-resistant prostate cancer with hormone replacement.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
January 05, 2024
Lead Product(s) : Opevesostat,Fludrocortisone Acetate,Glucocorticoid
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Merck & Co
Deal Size : Undisclosed
Deal Type : Collaboration
Details : ODM-208 is an oral, non-steroidal inhibitor of CYP11A1 currently being evaluated in a Phase 2 clinical trial for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC).
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : $290.0 million
July 13, 2022
Lead Product(s) : Opevesostat,Fludrocortisone Acetate,Glucocorticoid
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Results from an Ongoing Phase I/II CYPIDES Trial of ODM-208 Presented at ASCO-GU
Details : ODM-208 is a novel, oral, non-steroidal and selective inhibitor of CYP11A1 enzyme developed by Orion for the treatment of prostate cancer. ODM-208 suppresses the production of all steroid hormones and their precursors that may activate AR signalling path...
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
February 18, 2022
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Fludrocortisone Acetate 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 Fludrocortisone Acetate manufacturer or Fludrocortisone Acetate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Fludrocortisone Acetate manufacturer or Fludrocortisone Acetate supplier.
PharmaCompass also assists you with knowing the Fludrocortisone Acetate API Price utilized in the formulation of products. Fludrocortisone Acetate API Price is not always fixed or binding as the Fludrocortisone Acetate Price is obtained through a variety of data sources. The Fludrocortisone Acetate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Fludrocortisone Acetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fludrocortisone Acetate, including repackagers and relabelers. The FDA regulates Fludrocortisone Acetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fludrocortisone Acetate 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 Fludrocortisone Acetate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fludrocortisone Acetate supplier is an individual or a company that provides Fludrocortisone Acetate active pharmaceutical ingredient (API) or Fludrocortisone Acetate finished formulations upon request. The Fludrocortisone Acetate suppliers may include Fludrocortisone Acetate API manufacturers, exporters, distributors and traders.
click here to find a list of Fludrocortisone Acetate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fludrocortisone Acetate DMF (Drug Master File) is a document detailing the whole manufacturing process of Fludrocortisone Acetate active pharmaceutical ingredient (API) in detail. Different forms of Fludrocortisone Acetate DMFs exist exist since differing nations have different regulations, such as Fludrocortisone Acetate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fludrocortisone Acetate DMF submitted to regulatory agencies in the US is known as a USDMF. Fludrocortisone Acetate USDMF includes data on Fludrocortisone Acetate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fludrocortisone Acetate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fludrocortisone Acetate 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 Fludrocortisone Acetate Drug Master File in Korea (Fludrocortisone Acetate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Fludrocortisone Acetate. The MFDS reviews the Fludrocortisone Acetate KDMF as part of the drug registration process and uses the information provided in the Fludrocortisone Acetate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Fludrocortisone Acetate 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 Fludrocortisone Acetate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Fludrocortisone Acetate suppliers with KDMF on PharmaCompass.
A Fludrocortisone Acetate CEP of the European Pharmacopoeia monograph is often referred to as a Fludrocortisone Acetate Certificate of Suitability (COS). The purpose of a Fludrocortisone Acetate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Fludrocortisone Acetate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Fludrocortisone Acetate to their clients by showing that a Fludrocortisone Acetate CEP has been issued for it. The manufacturer submits a Fludrocortisone Acetate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Fludrocortisone Acetate CEP holder for the record. Additionally, the data presented in the Fludrocortisone Acetate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Fludrocortisone Acetate DMF.
A Fludrocortisone Acetate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Fludrocortisone Acetate CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Fludrocortisone Acetate suppliers with CEP (COS) on PharmaCompass.
A Fludrocortisone Acetate written confirmation (Fludrocortisone Acetate WC) is an official document issued by a regulatory agency to a Fludrocortisone Acetate manufacturer, verifying that the manufacturing facility of a Fludrocortisone Acetate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Fludrocortisone Acetate APIs or Fludrocortisone Acetate finished pharmaceutical products to another nation, regulatory agencies frequently require a Fludrocortisone Acetate WC (written confirmation) as part of the regulatory process.
click here to find a list of Fludrocortisone Acetate 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 Fludrocortisone Acetate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Fludrocortisone Acetate 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 Fludrocortisone Acetate 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 Fludrocortisone Acetate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Fludrocortisone Acetate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Fludrocortisone Acetate suppliers with NDC on PharmaCompass.
Fludrocortisone Acetate 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 Fludrocortisone Acetate 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 Fludrocortisone Acetate GMP manufacturer or Fludrocortisone Acetate GMP API supplier for your needs.
A Fludrocortisone Acetate CoA (Certificate of Analysis) is a formal document that attests to Fludrocortisone Acetate's compliance with Fludrocortisone Acetate specifications and serves as a tool for batch-level quality control.
Fludrocortisone Acetate CoA mostly includes findings from lab analyses of a specific batch. For each Fludrocortisone Acetate 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.
Fludrocortisone Acetate may be tested according to a variety of international standards, such as European Pharmacopoeia (Fludrocortisone Acetate EP), Fludrocortisone Acetate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Fludrocortisone Acetate USP).
