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Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

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CEP/COS

CEP/COS Certifications

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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)

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5 RELATED EXCIPIENT COMPANIES

6EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as:
Molecular Formula
C12H17NO20S3-4
Molecular Weight
591.5  g/mol
InChI Key
OHJKXVLJWUPWQG-IUYNYSEKSA-J

Dalteparin sodium
1 2D Structure

Dalteparin sodium

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(4S,6R)-6-[(2R,4R)-4,6-dihydroxy-5-(sulfonatoamino)-2-(sulfonatooxymethyl)oxan-3-yl]oxy-3,4-dihydroxy-5-sulfonatooxyoxane-2-carboxylate
2.1.2 InChI
InChI=1S/C12H21NO20S3/c14-4-3(13-34(20,21)22)11(19)30-2(1-29-35(23,24)25)7(4)31-12-9(33-36(26,27)28)6(16)5(15)8(32-12)10(17)18/h2-9,11-16,19H,1H2,(H,17,18)(H,20,21,22)(H,23,24,25)(H,26,27,28)/p-4/t2-,3?,4-,5?,6+,7?,8?,9?,11?,12-/m1/s1
2.1.3 InChI Key
OHJKXVLJWUPWQG-IUYNYSEKSA-J
2.1.4 Canonical SMILES
C(C1C(C(C(C(O1)O)NS(=O)(=O)[O-])O)OC2C(C(C(C(O2)C(=O)[O-])O)O)OS(=O)(=O)[O-])OS(=O)(=O)[O-]
2.1.5 Isomeric SMILES
C([C@@H]1C([C@@H](C(C(O1)O)NS(=O)(=O)[O-])O)O[C@H]2C([C@H](C(C(O2)C(=O)[O-])O)O)OS(=O)(=O)[O-])OS(=O)(=O)[O-]
2.2 Create Date
2009-05-14
3 Chemical and Physical Properties
Molecular Weight 591.5 g/mol
Molecular Formula C12H17NO20S3-4
XLogP3-5.6
Hydrogen Bond Donor Count5
Hydrogen Bond Acceptor Count21
Rotatable Bond Count6
Exact Mass590.95060545 g/mol
Monoisotopic Mass590.95060545 g/mol
Topological Polar Surface Area376 Ų
Heavy Atom Count36
Formal Charge-4
Complexity1040
Isotope Atom Count0
Defined Atom Stereocenter Count4
Undefined Atom Stereocenter Count6
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 4  
Drug NameHeparin sodium in plastic container
Active IngredientHeparin sodium
Dosage FormInjectable
RouteInjection
Strength10,000 units/ml; 5,000 units/ml; 20,000 units/ml; 1,000 units/ml
Market StatusPrescription
CompanyFresenius Kabi Usa

2 of 4  
Drug NameHeparin sodium preservative free
Active IngredientHeparin sodium
Dosage FormInjectable
RouteInjection
Strength10,000 units/ml; 1,000 units/ml
Market StatusPrescription
CompanyHospira; Shenzhen Techdow; Pfizer; Fresenius Kabi Usa; Sagent Pharms

3 of 4  
Drug NameHeparin sodium in plastic container
Active IngredientHeparin sodium
Dosage FormInjectable
RouteInjection
Strength10,000 units/ml; 5,000 units/ml; 20,000 units/ml; 1,000 units/ml
Market StatusPrescription
CompanyFresenius Kabi Usa

4 of 4  
Drug NameHeparin sodium preservative free
Active IngredientHeparin sodium
Dosage FormInjectable
RouteInjection
Strength10,000 units/ml; 1,000 units/ml
Market StatusPrescription
CompanyHospira; Shenzhen Techdow; Pfizer; Fresenius Kabi Usa; Sagent Pharms

API SUPPLIERS

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01

Sanofi

France

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

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Compamed
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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Digital Content Digital Content
USDMF Inactive-api CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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02

GLAND PHARMA LIMITED

India

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

Compamed
Not Confirmed
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GLAND PHARMA LIMITED

India

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

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Compamed
Not Confirmed
USDMF arrow-down CEP/COS JDMF EU-WCInactive-api NDC KDMF VMF Others AUDIT
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03

Changzhou Qianhong

China

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

Compamed
Not Confirmed
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Changzhou Qianhong

China

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

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Compamed
Not Confirmed
USDMF arrow-down CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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04

Shandong Chenzhong Biopharmaceutic...

China

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

Compamed
Not Confirmed
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Shandong Chenzhong Biopharmaceutic...

China

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

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Compamed
Not Confirmed
USDMF arrow-down CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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05

Dongying Tiandong Pharmaceutical C...

China

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

Compamed
Not Confirmed
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Dongying Tiandong Pharmaceutical C...

China

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

arrow
Compamed
Not Confirmed
USDMF Inactive-api CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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06

ALP Pharm

China

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

Compamed
Not Confirmed
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ALP Pharm

China

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

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Compamed
Not Confirmed
USDMF Inactive-api CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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07

Opocrin SpA

Italy

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

Compamed
Not Confirmed
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Opocrin SpA

Italy

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

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Compamed
Not Confirmed
USDMF Inactive-api CEP/COS JDMF arrow-down EU-WC NDC KDMF VMF Others AUDIT
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08

Leo Pharma

Denmark

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

Compamed
Not Confirmed
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Leo Pharma

Denmark

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

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Compamed
Not Confirmed
USDMF Inactive-api CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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09

HEBEI CHANGSHAN BIOCHEMICAL PHARMA...

China

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

Compamed
Not Confirmed
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HEBEI CHANGSHAN BIOCHEMICAL PHARMA...

China

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

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Compamed
Not Confirmed
USDMF Inactive-api CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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10

Reliable Biopharmaceutical Corpora...

U.S.A

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

Compamed
Not Confirmed
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Reliable Biopharmaceutical Corpora...

U.S.A

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

arrow
Compamed
Not Confirmed
USDMF Inactive-api CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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USDMF

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01

euroPLX 86 Munich
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 9939

Submission : 1992-11-02

Status : Inactive

Type : II

Sanofi Company Banner

02

euroPLX 86 Munich
Not Confirmed

03

euroPLX 86 Munich
Not Confirmed

03

euroPLX 86 Munich
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2018-02-22

Pay. Date : 2014-07-25

DMF Number : 20541

Submission : 2007-03-27

Status : Active

Type : II

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04

euroPLX 86 Munich
Not Confirmed

04

05

Gland Pharma Ltd

India

USDMF

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euroPLX 86 Munich
Not Confirmed

06

euroPLX 86 Munich
Not Confirmed

06

euroPLX 86 Munich
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 29154

Submission : 2015-03-06

Status : Inactive

Type : II

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07

euroPLX 86 Munich
Not Confirmed

07

08

Opocrin Spa

Italy

USDMF

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euroPLX 86 Munich
Not Confirmed

08

Opocrin Spa

Italy
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euroPLX 86 Munich
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 19658

Submission : 2006-08-04

Status : Inactive

Type : II

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09

euroPLX 86 Munich
Not Confirmed

09

euroPLX 86 Munich
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 19038

Submission : 2005-12-15

Status : Inactive

Type : II

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euroPLX 86 Munich
Not Confirmed

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Listed Suppliers

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01

Biological E

India
American Pharma Summit
Not Confirmed
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Biological E

India
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American Pharma Summit
Not Confirmed

Dalteparin sodium

About the Company : Biological E Limited, established in 1953 is globally focused one of the largest manufacturer of Human Vaccines, currently manufacturing Tetanus, DT, DTP, Td, Hepatitis B, DTP-HepB...

Biological E Limited, established in 1953 is globally focused one of the largest manufacturer of Human Vaccines, currently manufacturing Tetanus, DT, DTP, Td, Hepatitis B, DTP-HepB-Hib (Pentavalent), Haemophillus Influenza TypeB, IPV, JE, Tetanus Antitoxin and Snake Antivenin. We have WHO prequalification for Tetanus, Pentavalent and Japanese Encephalitis vaccines. Our Vaccines are exported through UN Organisations & PAHO and to various global markets. Endeavours to deliver path-breaking and innovative Vaccines and pharmaceuticals in future. Inaddition, we manufacture Finished Formulations & APIs in different dedicated facilities.
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02

American Pharma Summit
Not Confirmed
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American Pharma Summit
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Dalteparin sodium

About the Company : Dongying Tiandong Pharmaceutical Co.,ltd founded in 1992, subordinated to Shandong Haike Chemical Group, is located in Dongying city, the center area of Yellow River Delta High-eff...

Dongying Tiandong Pharmaceutical Co.,ltd founded in 1992, subordinated to Shandong Haike Chemical Group, is located in Dongying city, the center area of Yellow River Delta High-efficiency Ecological Economic Zone and Shandong Peninsula Blue Economic Zone, specially engaging in development, production and sales of polysaccharide products. The company is entitled as High and New Tech Enterprise in ShandongProvince. The company focuses on low-molecular weight heparins, heparin sodium and heparin calcium and so on, as the biggest low-molecular weight heparin API manufacturer in China. The injection workshop has been built with annual capacity of 21 million units of aqueous solution injections, which makes the company to have the complete industry chain from API to injection product and updates the heparin industry chain. Tiandong company is the only one to pass EDQM inspection, granted COS for enoxapairn sodium in China. Moreover, its enoxaparin sodium has been granted with Brazil GMP certificate, Swedish GMP certificate and French GMP certificate successively, and completed the registrations in many other countries and regions, and has been exported to more than forty countries in the world. The company keeps long-term close partnership with School of Pharmaceutical Sciences, ShandongUniversity, which strengthens our innovative ability of R & D. The company has applied 15 invention patents or utility model patents associated with heparin products. In 2009, the company has undertaken the national Major Creation of new drugs project on Quality Standards Study and Establishment of Five Low Molecular Weight Heparins. Over 20 years, the company has always made efforts to provide better pharmaceutical products and services for people, and established impeccable production service management system and quality management system by years of practices and innovation to assure product quality and the interests of clients.
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03

American Pharma Summit
Not Confirmed
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Nadroparine

About the Company : A globally renowned manufacturer of Small Volume Parenterals (SVPs), Gland Pharma was founded in 1978 at Hyderabad by a visionary, PVN Raju, who has always thought far ahead of his...

A globally renowned manufacturer of Small Volume Parenterals (SVPs), Gland Pharma was founded in 1978 at Hyderabad by a visionary, PVN Raju, who has always thought far ahead of his time. Since inception, Gland Pharma stands testimony to the founder’s exemplary commitment to Quality, having emerged as a global player with presence in about 90 countries in five continents. We have a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions and ophthalmic solutions.
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04

American Pharma Summit
Not Confirmed
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American Pharma Summit
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Dalteparin sodium

About the Company : Hanways Chempharm Co., Limited, the former one is Hubei Hanways Pharchem CO.,Limited, set up in 2009 in Wuhan, China. We are engaged in supplying APIs, pharmaceutical intermediate...

Hanways Chempharm Co., Limited, the former one is Hubei Hanways Pharchem CO.,Limited, set up in 2009 in Wuhan, China. We are engaged in supplying APIs, pharmaceutical intermediates, and fine chemicals for worldwide markets. With decades of development, now we grow to a leading and outstanding company. We are not just a trading company, but a comprehensive solutions supplier. With our sound knowledge of pharmaceutical business, our advantage is to integrate resources and adapt to all different demands of markets. We are a young but dynamic and energetic company with high efficient and high flexible decision making system.
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06

American Pharma Summit
Not Confirmed
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American Pharma Summit
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Dalteparin sodium

About the Company : Prajna is an innovation driven pharmaceutical company. We dedicated to Research, Process development and Manufacturing APIs and Advanced Intermediates for Active Pharmaceutical Ing...

Prajna is an innovation driven pharmaceutical company. We dedicated to Research, Process development and Manufacturing APIs and Advanced Intermediates for Active Pharmaceutical Ingredients (APIs) for the global pharmaceutical companies. It provides value-added services in Contract Research, Custom Synthesis, and Specialties Scientific technology (Green Process, APIs Process Development, Polymorphism, Crystallisation and Purification) for Pharmaceutical and Life Sciences industry.
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07

American Pharma Summit
Not Confirmed
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American Pharma Summit
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Nadroparine

About the Company : Established in 2002, Tecoland represents selected cGMP manufacturers with proven capabilities in organic synthesis, fermentation production as well as process and method developmen...

Established in 2002, Tecoland represents selected cGMP manufacturers with proven capabilities in organic synthesis, fermentation production as well as process and method development. Tecoland provides high quality APIs to the pharmaceutical industry, with reliable technical and regulatory support such as USDMF, CEP, EDMF that are critical to the speedy approval of our customers’ regulatory filings.
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Europe

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01

A. Menarini GmbH

Australia
Compamed
Not Confirmed
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A. Menarini GmbH

Australia
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Compamed
Not Confirmed

Heparinum natricum

Brand Name : Lioton 1000

Dosage Form : Gel

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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02

Compamed
Not Confirmed
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Compamed
Not Confirmed

Nadroparine

Brand Name : Seledie

Dosage Form : Nadroparin 15.200Iu 2 Units Parenteral Use

Dosage Strength : 2 Syringes SC 15,200 IU 0.8 ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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03

LEO Pharma AB

Denmark
Compamed
Not Confirmed
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LEO Pharma AB

Denmark
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Compamed
Not Confirmed

heparinnatrium

Brand Name : Heparin LEO

Dosage Form : INJEKTIONSVÄTSKA, LÖSNING

Dosage Strength : 25000 IE/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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04

LEO Pharma AB

Denmark
Compamed
Not Confirmed
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LEO Pharma AB

Denmark
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Compamed
Not Confirmed

tinzaparinnatrium

Brand Name : Innohep

Dosage Form : SOLUTION FOR INJECTION, PRE-FILLED SYRINGE

Dosage Strength : 3500 ANTI-XA IU

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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05

Pfizer

U.S.A
Compamed
Not Confirmed
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Pfizer

U.S.A
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Compamed
Not Confirmed

dalteparin sodium

Brand Name : Fragmin

Dosage Form : SOLUTION FOR INJECTION, PRE-FILLED SYRINGE

Dosage Strength : 5000 IU

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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06

Compamed
Not Confirmed
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Compamed
Not Confirmed

Nadroparine

Brand Name : Fragmin

Dosage Form : Dalteparin 100.000Iu 1 Unit Parenteral Use

Dosage Strength : 1 vial multid SC 100,000 IU 4 ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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Pfizer AG

U.S.A
Compamed
Not Confirmed
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Pfizer AG

U.S.A
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Compamed
Not Confirmed

Dalteparinum sodium

Brand Name : Fragmin

Dosage Form : Inj Solution

Dosage Strength : 100000u/4ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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08

Pfizer AG

U.S.A
Compamed
Not Confirmed
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Pfizer AG

U.S.A
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Compamed
Not Confirmed

Dalteparinum sodium

Brand Name : Fragmin

Dosage Form : Inj Loose

Dosage Strength : 12500iu/0.5ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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09

Compamed
Not Confirmed
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Compamed
Not Confirmed

Nadroparinum calcicum

Brand Name : Fraxiforte 0.8 ml

Dosage Form : Inj Loose

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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10

Compamed
Not Confirmed
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Compamed
Not Confirmed

Nadroparinum calcicum

Brand Name : Fraxiparine 1 ml

Dosage Form : Inj. L?s

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - INJECTABLE;SUBCUTANEOUS - 10,000IU/M...DOSAGE - INJECTABLE;SUBCUTANEOUS - 10,000IU/ML (10,000IU/ML)

USFDA APPLICATION NUMBER - 20287

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DOSAGE - INJECTABLE;SUBCUTANEOUS - 10,000IU/4...DOSAGE - INJECTABLE;SUBCUTANEOUS - 10,000IU/4ML (2,500IU/ML)

USFDA APPLICATION NUMBER - 20287

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DOSAGE - INJECTABLE;SUBCUTANEOUS - 12,500IU/0...DOSAGE - INJECTABLE;SUBCUTANEOUS - 12,500IU/0.5ML (25,000IU/ML)

USFDA APPLICATION NUMBER - 20287

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DOSAGE - INJECTABLE;SUBCUTANEOUS - 15,000IU/0...DOSAGE - INJECTABLE;SUBCUTANEOUS - 15,000IU/0.6ML (25,000IU/ML)

USFDA APPLICATION NUMBER - 20287

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DOSAGE - INJECTABLE;SUBCUTANEOUS - 18,000IU/0...DOSAGE - INJECTABLE;SUBCUTANEOUS - 18,000IU/0.72ML (25,000IU/ML)

USFDA APPLICATION NUMBER - 20287

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DOSAGE - INJECTABLE;SUBCUTANEOUS - 2,500IU/0....DOSAGE - INJECTABLE;SUBCUTANEOUS - 2,500IU/0.2ML (12,500IU/ML)

USFDA APPLICATION NUMBER - 20287

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DOSAGE - INJECTABLE;SUBCUTANEOUS - 5,000IU/0....DOSAGE - INJECTABLE;SUBCUTANEOUS - 5,000IU/0.2ML (25,000IU/ML)

USFDA APPLICATION NUMBER - 20287

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DOSAGE - INJECTABLE;SUBCUTANEOUS - 7,500IU/0....DOSAGE - INJECTABLE;SUBCUTANEOUS - 7,500IU/0.3ML (25,000IU/ML)

USFDA APPLICATION NUMBER - 20287

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DOSAGE - INJECTABLE;SUBCUTANEOUS - 95,000IU/3...DOSAGE - INJECTABLE;SUBCUTANEOUS - 95,000IU/3.8ML (25,000IU/ML)

USFDA APPLICATION NUMBER - 20287

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