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Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

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CEP/COS

CEP/COS Certifications

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JDMF

JDMFs Filed

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EU WC

EU WC

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KDMF

KDMF

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NDC API

NDC API

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VMF

NDC API

API REF. PRICE (USD/KG)

MARKET PLACE

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

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FDA Orange Book

FDA (Orange Book)

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Europe

Europe

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Canada

Canada

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Australia

Australia

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FDF Dossiers

DRUG PRODUCT COMPOSITIONS

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USP

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Health Canada Patents

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GLOBAL SALES INFORMATION

US Medicaid

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Finished Drug Prices

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0RELATED EXCIPIENT COMPANIES

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Chemistry

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Also known as: 4-cyclohexylpyrrolidine-2-carboxylic acid, 9002-01-1, 1219214-76-2, 4-cyclohexyl-pyrrolidine-2-carboxylic acid, Streptokinase from streptococcus hemo-lyticus, Mfcd08061929
Molecular Formula
C11H19NO2
Molecular Weight
197.27  g/mol
InChI Key
XRZWVSXEDRYQGC-UHFFFAOYSA-N

Streptokinase
1 2D Structure

Streptokinase

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
4-cyclohexylpyrrolidine-2-carboxylic acid
2.1.2 InChI
InChI=1S/C11H19NO2/c13-11(14)10-6-9(7-12-10)8-4-2-1-3-5-8/h8-10,12H,1-7H2,(H,13,14)
2.1.3 InChI Key
XRZWVSXEDRYQGC-UHFFFAOYSA-N
2.1.4 Canonical SMILES
C1CCC(CC1)C2CC(NC2)C(=O)O
2.2 Synonyms
2.2.1 Depositor-Supplied Synonyms

1. 4-cyclohexylpyrrolidine-2-carboxylic Acid

2. 9002-01-1

3. 1219214-76-2

4. 4-cyclohexyl-pyrrolidine-2-carboxylic Acid

5. Streptokinase From Streptococcus Hemo-lyticus

6. Mfcd08061929

7. 4-cyclohexylproline

8. Schembl197230

9. Dtxsid00864144

10. Act14087

11. Bcp13492

12. Akos015962191

13. Sb30285

14. Sb31900

15. 4-cyclohexylpyrrolidine-2-carboxylicacid

16. Ac-13801

17. Sy030455

18. Db-040425

19. Ft-0601991

2.3 Create Date
2006-10-25
3 Chemical and Physical Properties
Molecular Weight 197.27 g/mol
Molecular Formula C11H19NO2
XLogP30.3
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count3
Rotatable Bond Count2
Exact Mass197.141578849 g/mol
Monoisotopic Mass197.141578849 g/mol
Topological Polar Surface Area49.3 Ų
Heavy Atom Count14
Formal Charge0
Complexity211
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count2
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1

API SUPPLIERS

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01

GSK

United Kingdom

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

CPHI Middle east
Not Confirmed
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GSK

United Kingdom

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

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CPHI Middle east
Not Confirmed
USDMF Inactive-api CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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02

BBT Biotech GmbH

Germany

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

CPHI Middle east
Not Confirmed
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BBT Biotech GmbH

Germany

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

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CPHI Middle east
Not Confirmed
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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03

Dongkook Pharmaceutical

South Korea

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

CPHI Middle east
Not Confirmed
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Dongkook Pharmaceutical

South Korea

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

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CPHI Middle east
Not Confirmed
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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04

Enomark

India

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

CPHI Middle east
Not Confirmed
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Enomark

India

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

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CPHI Middle east
Not Confirmed
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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Levim Lifetech

India

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

CPHI Middle east
Not Confirmed
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Levim Lifetech

India

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

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CPHI Middle east
Not Confirmed
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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USDMF

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01

Beecham Laboratories

United Kingdom

USDMF

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CPHI Middle east
Not Confirmed

01

Beecham Laboratories

United Kingdom
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CPHI Middle east
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 27158

Submission : 1987-05-22

Status : Inactive

Type : II

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Listed Suppliers

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01

CPHI Middle east
Not Confirmed
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CPHI Middle east
Not Confirmed

Streptokinase

About the Company : BBT Biotech GmbH is a Contract Service Organization (CSO) in the worldwide growing bio-pharmaceutical industry. We have expertise in sophisticated manufacturing systems of therapeu...

BBT Biotech GmbH is a Contract Service Organization (CSO) in the worldwide growing bio-pharmaceutical industry. We have expertise in sophisticated manufacturing systems of therapeutically relevant, healthy micro-organisms and special protein purification methods, all developed in-house. The combination of several production steps, which we offer, combined with perfect process technology and state-of-the-art control systems, ensures custom-tailored, high-standard products.
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02

CPHI Middle east
Not Confirmed
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CPHI Middle east
Not Confirmed

Streptokinase

About the Company : Total healthcare group in Korea that delivers healthy value with sincere heart and contributes to customers’ life and society.The most important thing for us is our healthy and h...

Total healthcare group in Korea that delivers healthy value with sincere heart and contributes to customers’ life and society.The most important thing for us is our healthy and happy life. We create healthier future with unchanging passion toward our customers.We communicate actively in order to identify the needs of consumers and stakeholders at every contact point
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Enomark

India
CPHI Middle east
Not Confirmed
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Enomark

India
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CPHI Middle east
Not Confirmed

Streptokinase

About the Company : ENOMARK Group of Companies stands as a prominent Contract Manufacturer, boasting a cutting-edge manufacturing facility in Ahmadabad (Gujarat) that complies with WHO-GMP standards. ...

ENOMARK Group of Companies stands as a prominent Contract Manufacturer, boasting a cutting-edge manufacturing facility in Ahmadabad (Gujarat) that complies with WHO-GMP standards. ENOMARK is known for its extensive product portfolio, which includes Tablets, Capsules, Dry Syrups, Protein Powders, Soft Gelatin Capsules, Gummy Candy, Liquid Orals, Oral Spray, Effervescent Tablets, Sachets and Oil.
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04

CPHI Middle east
Not Confirmed
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CPHI Middle east
Not Confirmed

Streptokinase

About the Company : Levim lifetech specialize in the development and commercialization of biopharmaceuticals that target healthcare needs in acute diseases, oncology, and metabolic disorders. Our prod...

Levim lifetech specialize in the development and commercialization of biopharmaceuticals that target healthcare needs in acute diseases, oncology, and metabolic disorders. Our product portfolio encompasses peptides, proteins, antibody fragments, and gene therapy products, all derived from recombinant technology. Additionally, we leverage macromolecule conjugation and innovative drug delivery technologies to enhance the efficacy of our offerings.
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South Africa

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01

Actor Pharma (Pty) Ltd

South Africa
Antibody Engineering
Not Confirmed
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Actor Pharma (Pty) Ltd

South Africa
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Antibody Engineering
Not Confirmed

Streptokinase

Brand Name : Streptase 750 000 Iu

Dosage Form : INJ

Dosage Strength : 750000iu

Packaging : 5X1iu

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Actor Pharma (Pty) Ltd

South Africa
Antibody Engineering
Not Confirmed
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Actor Pharma (Pty) Ltd

South Africa
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Antibody Engineering
Not Confirmed

Streptokinase

Brand Name : Streptase 1 500 000 Iu

Dosage Form : INJ

Dosage Strength : 1500000iu

Packaging : 5X1iu

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Gen-Eye (pty) Ltd

South Africa
Antibody Engineering
Not Confirmed
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Gen-Eye (pty) Ltd

South Africa
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Antibody Engineering
Not Confirmed

Streptokinase

Brand Name : Fibreaker 1500000 IU

Dosage Form : INF

Dosage Strength : 1500000IU

Packaging : 5X1IU

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Listed Dossiers

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01

Biomed Lublin

Poland
Antibody Engineering
Not Confirmed
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Biomed Lublin

Poland
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Antibody Engineering
Not Confirmed

Streptokinase; Streptodornase

Brand Name : DISTREPTAZA

Dosage Form : Rectal Suppository

Dosage Strength : 15000IU; 1250IU

Packaging : 2 g, Blister of PCV in cardboard box 6 or 10 items

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Poland

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Biomed Lublin

Poland
Antibody Engineering
Not Confirmed
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Biomed Lublin

Poland
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Antibody Engineering
Not Confirmed

Streptokinase; Streptodornase

Dosage : Rectal Suppository

Dosage Strength : 15000IU; 1250IU

Brand Name : DISTREPTAZA

Approval Date :

Application Number :

Registration Country : Poland

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02

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

Streptokinase

Brand Name :

Dosage Form : Vial

Dosage Strength : 750000IU

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

Streptokinase

Dosage : Vial

Dosage Strength : 750000IU

Brand Name :

Approval Date :

Application Number :

Registration Country : India

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03

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

Streptokinase

Brand Name :

Dosage Form : Vial

Dosage Strength : 1500000IU

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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03

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

Streptokinase

Dosage : Vial

Dosage Strength : 1500000IU

Brand Name :

Approval Date :

Application Number :

Registration Country : India

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04

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

Streptokinase

Brand Name :

Dosage Form : Injection

Dosage Strength : 1500000IU

Packaging : Lyophilized Powder - Vial

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Egypt

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Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

Streptokinase

Dosage : Injection

Dosage Strength : 1500000IU

Brand Name :

Approval Date :

Application Number :

Registration Country : Egypt

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05

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

Streptokinase

Brand Name :

Dosage Form : Injection

Dosage Strength : 1500000IU

Packaging : 5 ml

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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05

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

Streptokinase

Dosage : Injection

Dosage Strength : 1500000IU

Brand Name :

Approval Date :

Application Number :

Registration Country : India

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06

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

Streptokinase

Brand Name :

Dosage Form : Injection

Dosage Strength : 7.500000IU

Packaging : 5 ml

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

Streptokinase

Dosage : Injection

Dosage Strength : 7.500000IU

Brand Name :

Approval Date :

Application Number :

Registration Country : India

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