MolPort-001-794-630

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Synopsis, Chemistry

APIs // Active Pharmaceutical Ingredients

67 Suppliers, 21 USDMF, 20 CEP/COS, 12 JDMF, 3 EU WC, 14 KDMF, 19 NDC API, 35 Listed Suppliers

DEVELOPMENTS

5 Drug(s) in Development

5 Drug(s) in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports, FDF Exports

INTERMEDIATES

2 Suppliers

2 Suppliers

DOSSIERs // Finished Dosage Forms

173 Dossiers, 32 FDA Orange Book, 84 Europe, 12 Canada, 5 Australia, 2 South Africa, 38 Listed Dossiers

DRUG PRODUCT COMPOSITION

CAPSULE;ORAL - 300MG, TABLET;ORAL - 250MG, TABLET;ORAL - 500MG

RELATED EXCIPIENT COMPANIES

Suppliers, 29 Kerry, 29 BASF, 26 Roquette, 12 Microlex e.U, 11 Corel Pharma Chem, 10 Sigachi Industries, 9 Gangwal Healthcare, 8 Gangwal Chemicals, 8 Seppic, 7 Nanjing Well Pharmaceutical, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 6 Lonza Capsugel, 6 SPI Pharma, 5 DFE Pharma, 5 Ideal Cures Pvt Ltd, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 4 Actylis, 4 ACG Worldwide, 4 Kima Chemical, 4 Boai NKY Pharmaceuticals Ltd, 3 Ingredion Pharma Solutions, 3 Vasa Pharmachem, 3 Pharmatrans-Sanaq, 3 The Dow Chemical Company, 3 Rochem International Inc, 3 Prachin Chemical, 2 Seqens, 2 Finar, 2 Clariant, 2 Nomisma Healthcare, 2 Qualicaps, 2 DKSH, 1 Shijiazhuang Huaxu Pharmaceutical, 1 Alcedo Pharmachem, 1 Vertellus, 1 Ulanqab Kema New Material, 1 Huzhou Sunflower Pharmaceutical, 1 Nanjing Bold Chemical, 1 Zhejiang Huakang Pharmaceutical, 1 Pharm-RX Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd

EXCIPIENTS BY APPLICATIONS

68 Fillers, Diluents & Binders, 52 Coating Systems & Additives, 32 Controlled & Modified Release, 31 Direct Compression, 25 Thickeners and Stabilizers, 25 Granulation, 24 Film Formers & Plasticizers, 21 Disintegrants & Superdisintegrants, 19 Solubilizers, 18 Taste Masking, 18 Topical, 15 Lubricants & Glidants, 13 Co-Processed Excipients, 12 Parenteral, 9 Chewable & Orodispersible Aids, 9 Empty Capsules, 5 API Stability Enhancers, 4 Rheology Modifiers, 4 Vegetarian Capsules, 3 Emulsifying Agents, 2 Coloring Agents, 2 Surfactant & Foaming Agents, 1 Soft Gelatin

GLOBAL SALES INFORMATION

32 US Medicaid Prescriptions, 76 Finished Drug Prices

MARKET PLACE

24 APIs, 12 DOSSIERS // FDF

PATENTS

2 Health Canada Patents

2 Health Canada Patents

ANALYTICAL SOLUTION(s)

1 BioAnalytical Methods, 4 EDQM Standards, 1 USP Standards, 6 Other Ref. Standards

DIGITAL CONTENT

1 Data Compilation & Company Tracker #PharmaFlow, 39 News

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Developments

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Strides Pharma Science

Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Contact Supplier

India

Virtual Booth

Digital Content

Strides Receives USFDA Approval for Ursodiol Capsules

Details:

Strides Pharma, has received approval for Ursodiol Capsules USP, 300 mg from the USFDA. The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Actigall® Capsules, 300 mg, of Allergan Sales, LLC.

Lead Product(s): Ursodeoxycholic Acid

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Undisclosed

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 January 25, 2021

CPhI Worldwide, Milan

Booth #5C33

envelop Contact Supplier

Strides Pharma Science

Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Contact Supplier

India

Virtual Booth

Digital Content

Strides Receives USFDA Approval for Ursodiol Tablets

Details:

USFDA approved generic version of Ursodiol Tablet, which is indicated for the treatment of patients with Primary Biliary Cirrhosis. It inhibits the absorption of cholesterol in the intestine and the secretion of cholesterol into bile, decreasing biliary cholesterol saturation.

Lead Product(s): Ursodeoxycholic Acid

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Urso Forte-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 August 21, 2020

CPhI Worldwide, Milan

Booth #5C33

envelop Contact Supplier

Intercept Pharmaceuticals

Upload your Marketing & Sales content on your company Virtual Booth, click HERE

Post an Enquiry

U.S.A

Virtual Booth

Digital Content

Alfasigma to Acquire Intercept Pharmaceuticals for $19.00 per Share in Cash, Expanding the Global Footprint of Alfasigma Via a Leader in Rare and Serious Liver Diseases

Details:

Through the acquisition, Alfasigma adds Ocaliva (obeticholic acid), a farnesoid X receptor agonist approved in the United States for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid in adults with an inadequate response to UDCA.

Lead Product(s): Obeticholic Acid,Ursodeoxycholic Acid

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Ocaliva

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Alfasigma

Deal Size: $794.0 million Upfront Cash: $794.0 million

Deal Type: Acquisition September 26, 2023

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Intercept Pharmaceuticals

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U.S.A

Virtual Booth

Digital Content

Intercept Announces Advanz Pharma to Acquire Ocaliva in PBC in Markets Outside the U.S. for up to $450MM, including $405MM Upfront and an Additional $45MM in Contingent Pay...

Details:

Agreement includes rights for Advanz to commercialize orphan drug Ocaliva® (Obeticholic Acid) for PBC outside the U.S., as well as the transition to Advanz of the international commercial and medical infrastructure of Intercept.

Lead Product(s): Obeticholic Acid,Ursodeoxycholic Acid

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Ocaliva

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Advanz Pharma

Deal Size: $450.0 million Upfront Cash: $405.0 million

Deal Type: Acquisition May 05, 2022

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AllianceRx Walgreens Prime

Upload your Marketing & Sales content on your company Virtual Booth, click HERE

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Country

Virtual Booth

Digital Content

AllianceRx Walgreens Prime Studies Use of Ocaliva® in the Treatment of Primary Biliary Cholangitis

Details:

A recent study evaluating Ocaliva® (obeticholic acid) in patients diagnosed with primary biliary cholangitis (PBC) revealed similar patient-reported adverse effects as in clinical trials while also exploring patient out-of-pocket cost and utilization.

Lead Product(s): Obeticholic Acid,Ursodeoxycholic Acid

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Ocaliva

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Duquesne University School of Pharmacy

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 30, 2022

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