Fludrocortisone Acetate

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Synopsis, Chemistry

APIs // Active Pharmaceutical Ingredients

12 Suppliers, 6 USDMF, 2 CEP/COS, 1 EU WC, 1 KDMF, 8 NDC API, 8 Listed Suppliers

DEVELOPMENTS

4 Drug(s) in Development

4 Drug(s) in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports

DOSSIERs // Finished Dosage Forms

16 Dossiers, 6 FDA Orange Book, 4 Europe, 1 Canada, 2 Australia, 1 South Africa, 2 Listed Dossiers

RELATED EXCIPIENT COMPANIES

Suppliers, 24 Kerry, 16 Roquette, 12 Sigachi Industries, 10 Microlex e.U, 9 Gangwal Healthcare, 7 DFE Pharma, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 5 Gangwal Chemicals, 4 Prachin Chemical, 4 Ingredion Pharma Solutions, 4 SPI Pharma, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 4 Vasa Pharmachem, 2 Pharmatrans-Sanaq, 1 Aeon Procare, 1 Nanjing Well Pharmaceutical, 1 Ideal Cures Pvt Ltd, 1 Jai Radhe Sales, 1 DKSH, 1 Seppic

EXCIPIENTS BY APPLICATIONS

54 Fillers, Diluents & Binders, 28 Disintegrants & Superdisintegrants, 25 Direct Compression, 13 Granulation, 13 Lubricants & Glidants, 11 Co-Processed Excipients, 11 Thickeners and Stabilizers, 6 Controlled & Modified Release, 5 Chewable & Orodispersible Aids, 5 Taste Masking, 4 Coating Systems & Additives, 2 Rheology Modifiers, 2 Film Formers & Plasticizers, 1 Emulsifying Agents, 1 Parenteral

GLOBAL SALES INFORMATION

8 US Medicaid Prescriptions, 3 Finished Drug Prices

MARKET PLACE

6 APIs, 3 DOSSIERS // FDF

ANALYTICAL SOLUTION(s)

2 EDQM Standards, 1 USP Standards, 2 JP Standards, 1 Other Ref. Standards

DIGITAL CONTENT

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Orion Corporation

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Finland

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Orion and MSD Announce Initiation of Two Phase 3 Trials Evaluating ODM-208/MK5684 in Certain Patients with Metastatic Castration-Resistant Prostate Cancer

Details:

ODM-208/MK5684 is an investigational CYP11A1 inhibitor, which is being evaluated in combination with hormone replacement therapy under phase 3 clinical trials for the treatment of metastatic castration-resistant prostate cancer (mCRPC).

Lead Product(s): MK5684,Dexamethasone,Fludrocortisone Acetate

Therapeutic Area: Oncology Product Name: ODM-208

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Merck & Co

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 05, 2024

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Orion Corporation

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Finland

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Orion and MSD Announce Global Collaboration for The Development and Commercialisation Of ODM-208, An Investigational Steroid Synthesis Inhibitor for The Treatment of Metast...

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).

Lead Product(s): ODM-208,Glucocorticoid,Fludrocortisone Acetate

Therapeutic Area: Oncology Product Name: ODM-208

Highest Development Status: Phase I/ Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: MSD Pharmaceuticals

Deal Size: Undisclosed Upfront Cash: $290.0 million

Deal Type: Collaboration July 13, 2022

Iran Expo

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Orion Corporation

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Finland

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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 pathway.

Lead Product(s): ODM-208,Glucocorticoid,Fludrocortisone Acetate

Therapeutic Area: Oncology Product Name: ODM-208

Highest Development Status: Phase I/ Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 18, 2022

Iran Expo

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ANI Pharmaceuticals Inc

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U.S.A

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ANI Pharmaceuticals Announces the FDA Approval and Imminent Launch of Fludrocortisone Acetate Tablets USP

Details:

ANI’s Fludrocortisone Acetate Tablets are the generic version of the Reference Listed Drug (RLD) Florinef, is a prescription medicine used to treat symptoms of Addison Disease (Adrenocortical Insufficiency) and Salt-Losing Forms of Congenital Adrenogenital Syndrome.

Lead Product(s): Fludrocortisone Acetate

Therapeutic Area: Endocrinology Product Name: Fludrocortisone Acetate-Generic

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 01, 2022

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