Synopsis
0
JDMF
0
VMF
DRUG PRODUCT COMPOSITIONS
0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
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
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
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...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
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'...
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
Axplora is your partner of choice for complex APIs.
About the Company : Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing partner to the world’s leading pharma & biotech companies, delivering top-qual...
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
About the Company : Nuray Chemicals Pvt Ltd, established in 2012 near Chennai, is an API manufacturer for highly regulated markets. Its state-of-the-art R&D facility specializes in synthesizing NCEs, ...
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
About the Company : Gonane Pharma is a contract pharmaceutical company based in Gujarat, India, specializing in the manufacturing and marketing of corticosteroids, hormones, antivirals, and oncology p...
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...
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 legacy of advancing health through innovation. Today, we offer one of the industry’s most comprehensive API portfolios ...
Willow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.
About the Company : Willow Birch Pharma, Inc. is a premier supplier of bulk APIs to North American Compounding Pharmacies, sourcing from FDA registered and GMP manufacturers. With licenses in all 50 s...
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) : 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
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]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Aeon Procare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DFE Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ideal Cures
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Keval Exports
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nitika Pharmaceutical Specialities
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharmatrans-Sanaq
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Prachin Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seppic
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Fillers, Diluents & Binders
Disintegrants & Superdisintegrants
Direct Compression
Granulation
Lubricants & Glidants
Co-Processed Excipients
Thickeners and Stabilizers
Chewable & Orodispersible Aids
Taste Masking
Controlled & Modified Release
Coating Systems & Additives
Rheology Modifiers
Film Formers & Plasticizers
Emulsifying Agents
Parenteral
Digital Content
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
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
14
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 Cortineff manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cortineff, including repackagers and relabelers. The FDA regulates Cortineff manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cortineff 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 Cortineff manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cortineff supplier is an individual or a company that provides Cortineff active pharmaceutical ingredient (API) or Cortineff finished formulations upon request. The Cortineff suppliers may include Cortineff API manufacturers, exporters, distributors and traders.
click here to find a list of Cortineff suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cortineff DMF (Drug Master File) is a document detailing the whole manufacturing process of Cortineff active pharmaceutical ingredient (API) in detail. Different forms of Cortineff DMFs exist exist since differing nations have different regulations, such as Cortineff USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cortineff DMF submitted to regulatory agencies in the US is known as a USDMF. Cortineff USDMF includes data on Cortineff's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cortineff USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cortineff 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 Cortineff Drug Master File in Korea (Cortineff KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Cortineff. The MFDS reviews the Cortineff KDMF as part of the drug registration process and uses the information provided in the Cortineff KDMF to evaluate the safety and efficacy of the drug.
After submitting a Cortineff 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 Cortineff API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Cortineff suppliers with KDMF on PharmaCompass.
A Cortineff CEP of the European Pharmacopoeia monograph is often referred to as a Cortineff Certificate of Suitability (COS). The purpose of a Cortineff CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cortineff EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cortineff to their clients by showing that a Cortineff CEP has been issued for it. The manufacturer submits a Cortineff CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cortineff CEP holder for the record. Additionally, the data presented in the Cortineff CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cortineff DMF.
A Cortineff CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cortineff 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 Cortineff suppliers with CEP (COS) on PharmaCompass.
A Cortineff written confirmation (Cortineff WC) is an official document issued by a regulatory agency to a Cortineff manufacturer, verifying that the manufacturing facility of a Cortineff active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cortineff APIs or Cortineff finished pharmaceutical products to another nation, regulatory agencies frequently require a Cortineff WC (written confirmation) as part of the regulatory process.
click here to find a list of Cortineff 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 Cortineff as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cortineff 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 Cortineff 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 Cortineff and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cortineff NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cortineff suppliers with NDC on PharmaCompass.
Cortineff 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 Cortineff 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 Cortineff GMP manufacturer or Cortineff GMP API supplier for your needs.
A Cortineff CoA (Certificate of Analysis) is a formal document that attests to Cortineff's compliance with Cortineff specifications and serves as a tool for batch-level quality control.
Cortineff CoA mostly includes findings from lab analyses of a specific batch. For each Cortineff 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.
Cortineff may be tested according to a variety of international standards, such as European Pharmacopoeia (Cortineff EP), Cortineff JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cortineff USP).
