Find Opicapone manufacturers, exporters & distributors on PharmaCompass

PharmaCompass

Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

0

CEP/COS

CEP/COS Certifications

0

JDMF

JDMFs Filed

0

EU WC

EU WC

0

VMF

NDC API

REF. STANDARDS OR IMPURITIES

0

EDQM

0

USP

0

JP

0

Others

FINISHED DOSAGE FORMULATIONS

0

Canada

Canada

0

South Africa

South Africa

0

Listed Dossiers

Listed Dossiers

FDF Dossiers

DRUG PRODUCT COMPOSITIONS

0RELATED EXCIPIENT COMPANIES

0EXCIPIENTS BY APPLICATIONS

PATENTS & EXCLUSIVITIES

0

Health Canada Patents

API REF. PRICE (USD/KG)

API/FDF Prices: Book a Demo to
explore the features and consider
upgrading later

MARKET PLACE

0

FDF

DIGITAL CONTENT

0

Data Compilation #PharmaFlow

0

Stock Recap #PipelineProspector

0

Weekly News Recap #Phispers

Chemistry

Click the arrow to open the dropdown
read-moreClick the button for full data set
Also known as:
Molecular Formula
C15H10Cl2N4O6
Molecular Weight
413.2  g/mol
InChI Key
HVGGGVAREUUJQV-VIZOYTHASA-N

Opicapone
1 2D Structure

Opicapone

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(4E)-4-[3-(2,5-dichloro-4,6-dimethyl-1-oxidopyridin-1-ium-3-yl)-2H-1,2,4-oxadiazol-5-ylidene]-2-hydroxy-6-nitrocyclohexa-2,5-dien-1-one
2.1.2 InChI
InChI=1S/C15H10Cl2N4O6/c1-5-10(13(17)20(24)6(2)11(5)16)14-18-15(27-19-14)7-3-8(21(25)26)12(23)9(22)4-7/h3-4,22H,1-2H3,(H,18,19)/b15-7+
2.1.3 InChI Key
HVGGGVAREUUJQV-VIZOYTHASA-N
2.1.4 Canonical SMILES
CC1=C(C(=[N+](C(=C1Cl)C)[O-])Cl)C2=NC(=C3C=C(C(=O)C(=C3)O)[N+](=O)[O-])ON2
2.1.5 Isomeric SMILES
CC1=C(C(=[N+](C(=C1Cl)C)[O-])Cl)C2=N/C(=C\3/C=C(C(=O)C(=C3)O)[N+](=O)[O-])/ON2
2.2 Create Date
2007-02-12
3 Chemical and Physical Properties
Molecular Weight 413.2 g/mol
Molecular Formula C15H10Cl2N4O6
XLogP32.1
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count7
Rotatable Bond Count1
Exact Mass411.9977394 g/mol
Monoisotopic Mass411.9977394 g/mol
Topological Polar Surface Area142 Ų
Heavy Atom Count27
Formal Charge0
Complexity818
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count1
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1

API SUPPLIERS

read-more
read-more

01

Suanfarma

Spain

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSuanfarma, at the Core of a Better Life.

Flag Spain
Digital Content Digital Content
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
Suanfarma

02

Metrochem API Private Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

Flag India
Digital Content Digital Content
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
Metrochem

03

Jinan Tantu Chemicals

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothJinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.

Flag China
Digital Content Digital Content
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
Jinan Tantu Chemicals

04

MSN Laboratories

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

AACR Annual meeting
Not Confirmed
arrow

MSN Laboratories

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

arrow
AACR Annual meeting
Not Confirmed
USDMF arrow-down CEP/COS JDMF EU-WC NDC arrow-down KDMF arrow-down VMF Others AUDIT
blank

05

Hetero Drugs

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

AACR Annual meeting
Not Confirmed
arrow

Hetero Drugs

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

arrow
AACR Annual meeting
Not Confirmed
USDMF arrow-down CEP/COS JDMF EU-WC NDC arrow-down KDMF VMF Others AUDIT
blank

06

Bial

Portugal

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

AACR Annual meeting
Not Confirmed
arrow

Bial

Portugal

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

arrow
AACR Annual meeting
Not Confirmed
USDMF arrow-down CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
blank

07

Bial

Portugal

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

AACR Annual meeting
Not Confirmed
arrow

Bial

Portugal

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

arrow
AACR Annual meeting
Not Confirmed
USDMF arrow-down CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
blank

08

Saptagir Laboratories

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

AACR Annual meeting
Not Confirmed
arrow

09

Royal Pharma

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

AACR Annual meeting
Not Confirmed
arrow

10

Medichem S.A

Spain

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

AACR Annual meeting
Not Confirmed
arrow
click full view
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

USDMF

read-more
read-moreread-more

01

Bial Portela And Ca Sa

Portugal

USDMF

arrow
PEGS Boston Summit
Not Confirmed

01

PEGS Boston Summit
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 34838

Submission : 2020-07-17

Status : Active

Type : II

blank

02

Bial-portela And Ca Sa

Portugal

USDMF

arrow
PEGS Boston Summit
Not Confirmed

02

PEGS Boston Summit
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 32198

Submission : 2017-11-08

Status : Active

Type : II

blank

03

Hetero Labs Ltd

India

USDMF

arrow
PEGS Boston Summit
Not Confirmed

03

PEGS Boston Summit
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 41566

Submission : 2025-03-27

Status : Active

Type : II

blank

04

BPI Europe
Not Confirmed
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

KDMF

read-more
read-moreread-more

01

BioProcess International Europe
Not Confirmed
arrow
arrow
BioProcess International Europe
Not Confirmed

Opicapone

Registrant Name : Aging Life Science Co., Ltd.

Registration Date : 2025-02-03

Registration Number : 434-71-ND

Manufacturer Name : MSN Life Sciences Private Li...

Manufacturer Address : Unit III, Sy. No. 544, 545 & 546, Bhiknoor (Village), Bhiknoor (Mandal), Kamareddy Di...

blank

02

Patheon

U.S.A
BioProcess International Europe
Not Confirmed
arrow

Patheon

U.S.A
arrow
BioProcess International Europe
Not Confirmed

Opicapone

Registrant Name : SK Chemical Co., Ltd.

Registration Date : 2019-11-26

Registration Number : Su703-6-ND

Manufacturer Name : Patheon Austria GmbH & Co KG...

Manufacturer Address : St. Peter Strasse 25, 4020 Linz Austria@[Micronising Manufactory]Via Sottobisio 42a/c...

blank

03

Pharmaron

U.S.A
BioProcess International Europe
Not Confirmed
arrow

Pharmaron

U.S.A
arrow
BioProcess International Europe
Not Confirmed

Opicapone

Registrant Name : SK Chemical Co., Ltd.

Registration Date : 2019-11-26

Registration Number : No. 703-5-ND

Manufacturer Name : Pharmaron Manufacturing Serv...

Manufacturer Address : Windmil industrial Estate, Shotton lane, Cramlington, NE23 3JL, United kingdom@[micro...

blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

NDC API

read-more
read-moreread-more

01

BPI Europe
Not Confirmed
arrow
arrow
BPI Europe
Not Confirmed

OPICAPONE

NDC Package Code : 68554-0174

Start Marketing Date : 2020-04-24

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

blank

02

BPI Europe
Not Confirmed
arrow
arrow
BPI Europe
Not Confirmed

OPICAPONE

NDC Package Code : 72640-025

Start Marketing Date : 2023-09-30

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

blank

03

Olon S.p.A.

Italy
BPI Europe
Not Confirmed
arrow

Olon S.p.A.

Italy
arrow
BPI Europe
Not Confirmed

OPICAPONE

NDC Package Code : 17337-0088

Start Marketing Date : 2019-11-19

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

blank

04

BPI Europe
Not Confirmed
arrow
arrow
BPI Europe
Not Confirmed

OPICAPONE

NDC Package Code : 45941-3057

Start Marketing Date : 2020-04-24

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Listed Suppliers

read-more
read-more

01

Suanfarma

Spain
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSuanfarma, at the Core of a Better Life.

Flag Spain
Digital Content Digital Content

Opicapone

About the Company : Suanfarma founded in 1993, is a B2B life science partner committed to health advancement by developing, manufacturing, & distributing high-quality APIs for the pharmaceutical indus...

Suanfarma founded in 1993, is a B2B life science partner committed to health advancement by developing, manufacturing, & distributing high-quality APIs for the pharmaceutical industry innovatively & sustainably. Backed by a robust global network of 12 strategically located local offices, we cater to the needs of over 400 active customers in 70+ countries. At Suanfarma we offer our CDMO capacity for fermentation & chemical synthesis projects, offering a One Stop Shop service with a solid track record, & which allows us to achieve success in the development, scaling, manufacturing, & commercialization of an API, either innovative or generic.
Suanfarma

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

Flag India
Digital Content Digital Content

Opicapone

About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...

Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product groups and has been approved by ISO 9001-2015, USFDA, WHO GMP, Cofepris & Japanese authorities. Metrochem’s in-depth industry knowledge, & hi-tech & advanced infrastructure, helps it provide quality products to its customers. Note: None of the products will be supplied to the countries where this could conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer
Metrochem

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothJinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.

Flag China
Digital Content Digital Content

Opicapone

About the Company : Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our core services include c...

Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our core services include customized R&D as well as the production of small molecule pharmaceutical intermediates and Active Pharmaceutical Ingredients (APIs) for both international and domestic pharmaceutical firms. Our capabilities span from laboratory-scale kilograms to commercial ton-scale production. Additionally, we are committed to independent research and development, as well as the production and sales of high-end pharmaceutical intermediates and API products.
Jinan Tantu Chemicals

04

PEGS Boston Summit
Not Confirmed
arrow
arrow
PEGS Boston Summit
Not Confirmed

Opicapone

About the Company : Aurore Life Sciences is a pure-play API manufacturer with a diverse portfolio of capabilities in delivering efficiencies to generic players globally. Founded in 2017 by a team with...

Aurore Life Sciences is a pure-play API manufacturer with a diverse portfolio of capabilities in delivering efficiencies to generic players globally. Founded in 2017 by a team with vast experience across the pharmaceutical value chain, the company is on a mission to become the most preferred partner for pharmaceuticals. At Aurore, we aim to push the boundaries to manufacture and deliver high quality products that can be relied upon by both customers and regulators. Our thrust on rapidly adding capabilities have led us to acquire, integrate and expand our reach across the geographies.
blank

05

Hetero Drugs

India
PEGS Boston Summit
Not Confirmed
arrow

Hetero Drugs

India
arrow
PEGS Boston Summit
Not Confirmed

Opicapone

About the Company : Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & F...

Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.
blank

06

Medichem S.A

Spain
PEGS Boston Summit
Not Confirmed
arrow

Medichem S.A

Spain
arrow
PEGS Boston Summit
Not Confirmed

Opicapone

About the Company : Medichem is an indepently-owned company based in Barcelona. Founded in 1972 and with more than 45 years, Medichem has been engaged in the process development and manufacture of Act...

Medichem is an indepently-owned company based in Barcelona. Founded in 1972 and with more than 45 years, Medichem has been engaged in the process development and manufacture of Active Pharmaceutical Ingredients (APIs), including Highly Potent. In 2016, Medichem merged with Combino Pharm, which is devoted to the development and manufacture (licensing) of Finished Dosage Forms. With this merger, Medichem has become a vertically integrated pharmaceutical company which can offer a complete range of products and services for the pharmaceutical industry with the highest standards of quality, operational excellence and environment respect.
blank

07

PEGS Boston Summit
Not Confirmed
arrow
arrow
PEGS Boston Summit
Not Confirmed

Opicapone

About the Company : Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products...

Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market and in the pipeline, MSN has 6 API (including Oncology) and one finished dosage facilities (one more for Oncology is being built) and an integrated R&D Center for Contract Research And Manufacturing Services (CRAMS) located in Hyderabad. MSN has won the trust of more than 250 customers across 65 countries around the globe covering the US, Europe, Latin America, Middle-East, Asia Pacific, Africa and CIS markets. Our product basket offers 100 APIs
blank

08

PEGS Boston Summit
Not Confirmed
arrow
arrow
PEGS Boston Summit
Not Confirmed

Opicapone

About the Company : Raghava Life Sciences Pvt. Ltd. (RLS), established in the year 2018, is an integrated small molecules chemistry Contract research, Development and Manufacturing Organization (CDMO)...

Raghava Life Sciences Pvt. Ltd. (RLS), established in the year 2018, is an integrated small molecules chemistry Contract research, Development and Manufacturing Organization (CDMO). RLS is offering chemistry services to clients across the globe.RLS is a technology driven organization with a flexible approach and expertise in Custom chemical synthesis, Process Research & Development and Scale-up. RLS main focus is Contract Research And Manufacturing Services (CRAMS) to support innovator companies/business partners globally. We develop and manufacture high quality generic Active Pharmaceutical Ingredients (APIs) for formulation companies
blank

09

Royal Pharma

India
PEGS Boston Summit
Not Confirmed
arrow

Royal Pharma

India
arrow
PEGS Boston Summit
Not Confirmed

Opicapone

About the Company : Royal pharma was started in 2007 – it’s a small scale Advanced Intermediates Manufacturing company. Facilities are in accordance to GMP standards. Currently working with Indian...

Royal pharma was started in 2007 – it’s a small scale Advanced Intermediates Manufacturing company. Facilities are in accordance to GMP standards. Currently working with Indian Multinational companies and also with European countries. Its an ISO 9001:2000 certified company. Facilities are in accordance to GMP standards. Currently working with Indian Multinational companies and also with European countries. Facilities are in accordance to GMP standards.
blank

10

PEGS Boston Summit
Not Confirmed
arrow
arrow
PEGS Boston Summit
Not Confirmed

Opicapone

About the Company : Saptagir Laboratories Private incorporated in 2016, is a manufacturer and supplier of Active Pharmaceutical Ingredients (APIs) and Intermediates for a wide range of therapeutic cat...

Saptagir Laboratories Private incorporated in 2016, is a manufacturer and supplier of Active Pharmaceutical Ingredients (APIs) and Intermediates for a wide range of therapeutic categories specifically focusing on Anti-Fungal and Anti-Platelets. Our vision is to attain market leadership in development of innovator molecules for the domestic and export market.
blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

API Reference Price

read-more
read-more
[{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1735497000,"product":"OPICAPONE","address":"PLOT NO.C-24, MSN HOUSE, INDUSTRIAL","city":"HYDERABAD, AP","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"BOGOTA","customer":"LABORATORIOS LEGRAND S.A","customerCountry":"COLOMBIA","quantity":"2.20","actualQuantity":"2.2","unit":"KGS","unitRateFc":"15000","totalValueFC":"32674.4","currency":"USD","unitRateINR":1261959.3818181818,"date":"30-Dec-2024","totalValueINR":"2776310.64","totalValueInUsd":"32674.4","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"6874432","productDescription":"API","marketType":"","country":"COLOMBIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"PLOT NO.C-24, MSN HOUSE, INDUSTRIAL, HYDERABAD, AP","customerAddress":""}]
30-Dec-2024
30-Dec-2024
KGS
overview
Loading...

Average Price (USD/KGS)

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API/FDF Prices: Book a Demo to explore the features and consider upgrading later

API Imports and Exports

Importing Country Total Quantity
(KGS)
Average Price
(USD/KGS)
Number of Transactions

Upgrade, download data, analyse, strategize, subscribe with us contact

Drugs in Development

read-more
read-more

Details:

Under the agreement, Amneal will have exclusive rights to market and distribute ONGENTYS (opicapone), a highly-selective COMT inhibitor, which is approved by USFDA as an add-on treatment to carbidopa/levodopa in patients with Parkinson’s disease experiencing Off episodes.


Lead Product(s): Opicapone

Therapeutic Area: Neurology Brand Name: Ongentys

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Amneal Pharmaceuticals

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement July 12, 2023

blank

01

Bial

Portugal
arrow
BioProcess International Europe
Not Confirmed

Bial

Portugal
arrow
BioProcess International Europe
Not Confirmed

Lead Product(s) : Opicapone

Therapeutic Area : Neurology

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Amneal Pharmaceuticals

Deal Size : Undisclosed

Deal Type : Licensing Agreement

Details : Under the agreement, Amneal will have exclusive rights to market and distribute ONGENTYS (opicapone), a highly-selective COMT inhibitor, which is approved by USFDA as an add-on treatment to carbidopa/levodopa in patients with Parkinson’s disease experi...

Product Name : Ongentys

Product Type : Other Small Molecule

Upfront Cash : Undisclosed

July 12, 2023

blank

Details:

ONGENTYS (Opicapone) is a once-daily, oral, peripheral, selective, and reversible catechol-O-methyltransferase (COMT) inhibitor as an add-on treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing "OFF"episodes.


Lead Product(s): Opicapone

Therapeutic Area: Neurology Brand Name: Ongentys

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 24, 2022

blank

02

BioProcess International Europe
Not Confirmed
BioProcess International Europe
Not Confirmed

Details : ONGENTYS (Opicapone) is a once-daily, oral, peripheral, selective, and reversible catechol-O-methyltransferase (COMT) inhibitor as an add-on treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing "OFF"episodes.

Product Name : Ongentys

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

October 24, 2022

blank

Details:

ONGENTYS (opicapone) is a reversible COMT inhibitor approved by the U.S. FDA as an add-on treatment to levodopa/carbidopa in patients with Parkinson's disease. ONGENTYS inhibits the COMT enzyme, which breaks down levodopa, making more levodopa available to reach the brain.


Lead Product(s): Opicapone

Therapeutic Area: Neurology Brand Name: Ongentys

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable September 15, 2022

blank

03

BioProcess International Europe
Not Confirmed
BioProcess International Europe
Not Confirmed

Details : ONGENTYS (opicapone) is a reversible COMT inhibitor approved by the U.S. FDA as an add-on treatment to levodopa/carbidopa in patients with Parkinson's disease. ONGENTYS inhibits the COMT enzyme, which breaks down levodopa, making more levodopa available ...

Product Name : Ongentys

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

September 15, 2022

blank

Details:

Results of the post-hoc analysis for ONGENTYS® (opicapone) Capsules indicate that 34.4% (332/964) of participants experienced an OFF episode before going to sleep for a mean duration of 1.8±1.2 hours.


Lead Product(s): Opicapone

Therapeutic Area: Neurology Brand Name: Ongentys

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable June 06, 2022

blank

04

BioProcess International Europe
Not Confirmed
BioProcess International Europe
Not Confirmed

Details : Results of the post-hoc analysis for ONGENTYS® (opicapone) Capsules indicate that 34.4% (332/964) of participants experienced an OFF episode before going to sleep for a mean duration of 1.8±1.2 hours.

Product Name : Ongentys

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

June 06, 2022

blank

Details:

Data demonstrated that newly approved Ongentys significantly reduced "off" time as an add-on therapy in patients with Parkinson's Disease taking Levodopa/Carbidopa only in a pooled Post-Hoc, sub-group analysis of Phase III studies.


Lead Product(s): Opicapone

Therapeutic Area: Neurology Brand Name: Ongentys

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable November 09, 2020

blank

05

BioProcess International Europe
Not Confirmed
BioProcess International Europe
Not Confirmed

Details : Data demonstrated that newly approved Ongentys significantly reduced "off" time as an add-on therapy in patients with Parkinson's Disease taking Levodopa/Carbidopa only in a pooled Post-Hoc, sub-group analysis of Phase III studies.

Product Name : Ongentys

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

November 09, 2020

blank

Details:

The new agreement provides both companies with a long-term partnership that will ensure continued supply for patients across the globe. Opicapone (Ongentys) is approved in Europe, USA, South Korea, Taiwan, Australia and Japan.


Lead Product(s): Opicapone

Therapeutic Area: Neurology Brand Name: Ongentys

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Bial

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement January 10, 2020

blank

06

Recipharm AB

Sweden
arrow
BPI Europe
Not Confirmed

Recipharm AB

Sweden
arrow
BPI Europe
Not Confirmed

Details : The new agreement provides both companies with a long-term partnership that will ensure continued supply for patients across the globe. Opicapone (Ongentys) is approved in Europe, USA, South Korea, Taiwan, Australia and Japan.

Product Name : Ongentys

Product Type : Other Small Molecule

Upfront Cash : Undisclosed

January 10, 2020

blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

INTERMEDIATE SUPPLIERS

read-more
read-more

01

BioProcess International Europe
Not Confirmed
arrow
BioProcess International Europe
Not Confirmed
arrow

CAS Number : CAS-91591-63-8

End Use API : Opicapone

About The Company : Blue Jet Healthcare is a global, science-driven pharmaceutical company specializing in collaboration, development, and manufacturing of advanced pharmaceutical ...

blank

02

BioProcess International Europe
Not Confirmed
arrow
BioProcess International Europe
Not Confirmed
arrow

CAS Number : CAS-121-34-6

End Use API : Opicapone

About The Company : Blue Jet Healthcare is a global, science-driven pharmaceutical company specializing in collaboration, development, and manufacturing of advanced pharmaceutical ...

blank

03

BioProcess International Europe
Not Confirmed
arrow
BioProcess International Europe
Not Confirmed
arrow

CAS Number : CAS-881-68-5

End Use API : Opicapone

About The Company : Blue Jet Healthcare is a global, science-driven pharmaceutical company specializing in collaboration, development, and manufacturing of advanced pharmaceutical ...

blank

04

BioProcess International Europe
Not Confirmed
arrow
BioProcess International Europe
Not Confirmed
arrow

CAS Number : 91591-63-8

End Use API : Opicapone

About The Company : Saptagir Laboratories Private incorporated in 2016, is a manufacturer and supplier of Active Pharmaceutical Ingredients (APIs) and Intermediates for a wide rang...

blank

05

BioProcess International Europe
Not Confirmed
arrow
BioProcess International Europe
Not Confirmed
arrow

CAS Number : 6635-20-7

End Use API : Opicapone

About The Company : Saptagir Laboratories Private incorporated in 2016, is a manufacturer and supplier of Active Pharmaceutical Ingredients (APIs) and Intermediates for a wide rang...

blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

FDF Dossiers

read-more
read-more

01

BioProcess International Europe
Not Confirmed
arrow
arrow
BioProcess International Europe
Not Confirmed

OPICAPONE

Brand Name : ONGENTYS

Dosage Form : CAPSULE;ORAL

Dosage Strength : 25MG

Packaging :

Approval Date : 2020-04-24

Application Number : 212489

Regulatory Info : RX

Registration Country : USA

blank

02

BioProcess International Europe
Not Confirmed
arrow
arrow
BioProcess International Europe
Not Confirmed

OPICAPONE

Brand Name : ONGENTYS

Dosage Form : CAPSULE;ORAL

Dosage Strength : 50MG

Packaging :

Approval Date : 2020-04-24

Application Number : 212489

Regulatory Info : RX

Registration Country : USA

blank

03

Bial

Portugal
BioProcess International Europe
Not Confirmed
arrow

Bial

Portugal
arrow
BioProcess International Europe
Not Confirmed

Opicaponum

Brand Name : Ongentys

Dosage Form : Kaps

Dosage Strength : 50mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

blank

04

Bial

Portugal
BioProcess International Europe
Not Confirmed
arrow

Bial

Portugal
arrow
BioProcess International Europe
Not Confirmed

Opicaponum

Brand Name : Ongentys

Dosage Form : Caps

Dosage Strength : 50mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

blank

05

Country
BioProcess International Europe
Not Confirmed
arrow

Country
arrow
BioProcess International Europe
Not Confirmed

Opicapone

Brand Name : Ongentys

Dosage Form :

Dosage Strength :

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Digital Content read-more

Create Content with PharmaCompass, ask us

NEWS #PharmaBuzz

read-more
read-more

Global Sales Information

Do you need Business Intel? Ask us

Market Place

Do you need sourcing support? Ask us

Patents & EXCLUSIVITIES

Check the patents & exclusivity for this product

ABOUT THIS PAGE

Looking for / Opicapone API manufacturers, exporters & distributors?

Opicapone manufacturers, exporters & distributors 1

52

PharmaCompass offers a list of Opicapone 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 Opicapone manufacturer or Opicapone supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Opicapone manufacturer or Opicapone supplier.

PharmaCompass also assists you with knowing the Opicapone API Price utilized in the formulation of products. Opicapone API Price is not always fixed or binding as the Opicapone Price is obtained through a variety of data sources. The Opicapone Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Opicapone

Opicapone Manufacturers

A Opicapone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Opicapone, including repackagers and relabelers. The FDA regulates Opicapone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Opicapone 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 Opicapone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Opicapone Suppliers

A Opicapone supplier is an individual or a company that provides Opicapone active pharmaceutical ingredient (API) or Opicapone finished formulations upon request. The Opicapone suppliers may include Opicapone API manufacturers, exporters, distributors and traders.

click here to find a list of Opicapone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Opicapone USDMF

A Opicapone DMF (Drug Master File) is a document detailing the whole manufacturing process of Opicapone active pharmaceutical ingredient (API) in detail. Different forms of Opicapone DMFs exist exist since differing nations have different regulations, such as Opicapone USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Opicapone DMF submitted to regulatory agencies in the US is known as a USDMF. Opicapone USDMF includes data on Opicapone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Opicapone USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Opicapone suppliers with USDMF on PharmaCompass.

Opicapone KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Opicapone Drug Master File in Korea (Opicapone KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Opicapone. The MFDS reviews the Opicapone KDMF as part of the drug registration process and uses the information provided in the Opicapone KDMF to evaluate the safety and efficacy of the drug.

After submitting a Opicapone 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 Opicapone API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Opicapone suppliers with KDMF on PharmaCompass.

Opicapone NDC

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 Opicapone as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Opicapone API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Opicapone 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Opicapone and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Opicapone NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Opicapone suppliers with NDC on PharmaCompass.

Opicapone GMP

Opicapone 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 Opicapone 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 Opicapone GMP manufacturer or Opicapone GMP API supplier for your needs.

Opicapone CoA

A Opicapone CoA (Certificate of Analysis) is a formal document that attests to Opicapone's compliance with Opicapone specifications and serves as a tool for batch-level quality control.

Opicapone CoA mostly includes findings from lab analyses of a specific batch. For each Opicapone 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.

Opicapone may be tested according to a variety of international standards, such as European Pharmacopoeia (Opicapone EP), Opicapone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Opicapone USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
Ask Us for Pharmaceutical Supplier and Partner
Ask Us, Find A Supplier / Partner
No Commissions, No Strings Attached, Get Connected for FREE

What are you looking for?

How can we help you?

The request can't be empty

Please read our Privacy Policy carefully

You must agree to the privacy policy

The name can't be empty
The company can't be empty.
The email can't be empty Please enter a valid email.
The mobile can't be empty