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Chemistry

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Also known as: (2s,3s,4r,5r,6r)-6-{[(2s,3s,4s,5r,6s)-6-{[(2r,3s,4s,5r)-2-carboxy-4,6-dihydroxy-5-(sulfooxy)oxan-3-yl]oxy}-2-hydroxy-4-(sulfomethyl)-5-(sulfooxy)oxan-3-yl]oxy}-3-{[(2r,3r,4r,5s,6r)-3-acetamido-4,5-dihydroxy-6-[(sulfooxy)methyl]oxan-2-yl]oxy}-4,5-dihydroxyoxane-2-carboxylic acid, Hepflush, Chembl526514, Gtpl4214, S01xa14, Bdbm50480251
Molecular Formula
C26H41NO34S4
Molecular Weight
1039.9  g/mol
InChI Key
ZFGMDIBRIDKWMY-PASTXAENSA-N

Heparin Sodium
A highly acidic mucopolysaccharide formed of equal parts of sulfated D-glucosamine and D-glucuronic acid with sulfaminic bridges. The molecular weight ranges from six to twenty thousand. Heparin occurs in and is obtained from liver, lung, mast cells, etc., of vertebrates. Its function is unknown, but it is used to prevent blood clotting in vivo and vitro, in the form of many different salts.
1 2D Structure

Heparin Sodium

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(2S,3S,4R,5R,6R)-3-[(2R,3R,4R,5S,6R)-3-acetamido-4,5-dihydroxy-6-(sulfooxymethyl)oxan-2-yl]oxy-6-[(2S,3S,4S,5R,6S)-6-[(2R,3S,4S,5R)-2-carboxy-4,6-dihydroxy-5-sulfooxyoxan-3-yl]oxy-2-hydroxy-4-(sulfomethyl)-5-sulfooxyoxan-3-yl]oxy-4,5-dihydroxyoxane-2-carboxylic acid
2.1.2 InChI
InChI=1S/C26H41NO34S4/c1-4(28)27-7-9(30)8(29)6(2-52-63(43,44)45)53-24(7)56-15-10(31)11(32)25(58-19(15)21(36)37)55-13-5(3-62(40,41)42)14(60-64(46,47)48)26(59-22(13)38)57-16-12(33)17(61-65(49,50)51)23(39)54-18(16)20(34)35/h5-19,22-26,29-33,38-39H,2-3H2,1H3,(H,27,28)(H,34,35)(H,36,37)(H,40,41,42)(H,43,44,45)(H,46,47,48)(H,49,50,51)/t5-,6+,7+,8+,9+,10+,11+,12-,13-,14+,15-,16-,17+,18+,19-,22-,23?,24+,25+,26-/m0/s1
2.1.3 InChI Key
ZFGMDIBRIDKWMY-PASTXAENSA-N
2.1.4 Canonical SMILES
CC(=O)NC1C(C(C(OC1OC2C(C(C(OC2C(=O)O)OC3C(C(C(OC3O)OC4C(C(C(OC4C(=O)O)O)OS(=O)(=O)O)O)OS(=O)(=O)O)CS(=O)(=O)O)O)O)COS(=O)(=O)O)O)O
2.1.5 Isomeric SMILES
CC(=O)N[C@@H]1[C@H]([C@@H]([C@H](O[C@@H]1O[C@H]2[C@@H]([C@H]([C@@H](O[C@@H]2C(=O)O)O[C@H]3[C@@H]([C@H]([C@H](O[C@@H]3O)O[C@H]4[C@@H]([C@H](C(O[C@H]4C(=O)O)O)OS(=O)(=O)O)O)OS(=O)(=O)O)CS(=O)(=O)O)O)O)COS(=O)(=O)O)O)O
2.2 Synonyms
2.2.1 MeSH Synonyms

1. Alpha Heparin

2. Alpha-heparin

3. Heparin

4. Heparin Sodium

5. Heparin, Sodium

6. Heparin, Unfractionated

7. Heparinic Acid

8. Liquaemin

9. Unfractionated Heparin

2.2.2 Depositor-Supplied Synonyms

1. (2s,3s,4r,5r,6r)-6-{[(2s,3s,4s,5r,6s)-6-{[(2r,3s,4s,5r)-2-carboxy-4,6-dihydroxy-5-(sulfooxy)oxan-3-yl]oxy}-2-hydroxy-4-(sulfomethyl)-5-(sulfooxy)oxan-3-yl]oxy}-3-{[(2r,3r,4r,5s,6r)-3-acetamido-4,5-dihydroxy-6-[(sulfooxy)methyl]oxan-2-yl]oxy}-4,5-dihydroxyoxane-2-carboxylic Acid

2. Hepflush

3. Chembl526514

4. Gtpl4214

5. S01xa14

6. Bdbm50480251

7. (2s,3s,4r,5r,6r)-3-[(2r,3r,4r,5s,6r)-3-acetamido-4,5-dihydroxy-6-(sulfooxymethyl)oxan-2-yl]oxy-6-[(2s,3s,4s,5r,6s)-6-[(2r,3s,4s,5r)-2-carboxy-4,6-dihydroxy-5-sulfooxyoxan-3-yl]oxy-2-hydroxy-4-(sulfomethyl)-5-sulfooxyoxan-3-yl]oxy-4,5-dihydroxyoxane-2-carboxylic Acid

2.2.3 Other Synonyms

1. 9005-49-6

2.3 Create Date
2007-12-05
3 Chemical and Physical Properties
Molecular Weight 1039.9 g/mol
Molecular Formula C26H41NO34S4
XLogP3-10.4
Hydrogen Bond Donor Count14
Hydrogen Bond Acceptor Count34
Rotatable Bond Count18
Exact Mass1039.0392821 g/mol
Monoisotopic Mass1039.0392821 g/mol
Topological Polar Surface Area589 Ų
Heavy Atom Count65
Formal Charge0
Complexity2140
Isotope Atom Count0
Defined Atom Stereocenter Count19
Undefined Atom Stereocenter Count1
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameHeparin sodium
Drug LabelIntravenous solutions with heparin sodium (derived from porcine intestinal mucosa) are sterile, nonpyrogenic fluids for intravenous administration. They contain no bacteriostat or antimicrobial agent or added buffer. Edetate disodium, anhydrous is ad...
Active IngredientHeparin sodium
Dosage FormInjectable
RouteInjection
Strength5,000 units/ml; 10,000 units/ml; 20,000 units/ml; 1,000 units/ml
Market StatusPrescription
CompanyHospira; Shenzhen Techdow; Sandoz; Pfizer; Fresenius Kabi Usa; Hikma Maple; Sagent Pharms

2 of 2  
Drug NameHeparin sodium
Drug LabelIntravenous solutions with heparin sodium (derived from porcine intestinal mucosa) are sterile, nonpyrogenic fluids for intravenous administration. They contain no bacteriostat or antimicrobial agent or added buffer. Edetate disodium, anhydrous is ad...
Active IngredientHeparin sodium
Dosage FormInjectable
RouteInjection
Strength5,000 units/ml; 10,000 units/ml; 20,000 units/ml; 1,000 units/ml
Market StatusPrescription
CompanyHospira; Shenzhen Techdow; Sandoz; Pfizer; Fresenius Kabi Usa; Hikma Maple; Sagent Pharms

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Anticoagulants

Agents that prevent BLOOD CLOTTING. (See all compounds classified as Anticoagulants.)


Fibrinolytic Agents

Fibrinolysin or agents that convert plasminogen to FIBRINOLYSIN. (See all compounds classified as Fibrinolytic Agents.)


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ROAD,HANGZHOU,310003SDNF CHINA","customerAddress":"3RD,FL,UJAGAR INDUSTRIAL ESTATE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1720809000,"product":"HEPARIN SODIUM(LICENCE NO.IL\/BD-014708 RC\/BD-002482)","address":"SCO.162-64, SECTOR 34-A,","city":"CHANDIGARH.","supplier":"KAIPA PHARMA LTD.","supplierCountry":"CHINA","foreign_port":"CHONGQING","customer":"HEALTH BIOTECH","customerCountry":"INDIA","quantity":"8.23","actualQuantity":"8.23","unit":"KGS","unitRateFc":"4787.1","totalValueFC":"39802.7","currency":"USD","unitRateINR":"404270.6","date":"13-Jul-2024","totalValueINR":"3327146.99","totalValueInUsd":"39802.7","indian_port":"Delhi Air","hs_no":"29349990","bill_no":"4489626","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"CHONGQING","supplierAddress":"KZ-28-94,BIOMEDICAL INDUSTRIAL PARK,PULI NEW AREA,ZHAOJIA STREET, KAIZHOU DISTRICT, Chongqing, , CHINA CHINA","customerAddress":"SCO.162-64, SECTOR 34-A,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725388200,"product":"HEPARIN SODIUM (5299.545 MIU)(23041.5 G)","address":"2NF FLOOR,BUILDING A,","city":"ANDHERI[W],MUMBAI,","supplier":"JIANGXI HAORAN BIOPHARMA CO LTD","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"GUFIC BIOSCIENCES","customerCountry":"INDIA","quantity":"23.04","actualQuantity":"23.0415","unit":"KGS","unitRateFc":"4266.5","totalValueFC":"99536.9","currency":"USD","unitRateINR":"362012.7","date":"04-Sep-2024","totalValueINR":"8341315.01","totalValueInUsd":"99536.9","indian_port":"Madras Air","hs_no":"29419090","bill_no":"5423305","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"369 YOUKOU ROAD NATIONAL HIGHTECH D EVELO PMENT ZONE NANCHANG JIANGXI P R CHINA , , CHINA CHINA CHINA","customerAddress":"2NF FLOOR,BUILDING A,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1727893800,"product":"HEPARIN SODIUM IP2022","address":"Village Khara Khari, Ogli, Ogli,","city":"KALA AMB","supplier":"ZHEJIANG MEDICINE CO LTD","supplierCountry":"CHINA","foreign_port":"HANGCHOW (HANGZHOU)","customer":"NIXI LABORATORIES PRIVATE LIMITED","customerCountry":"INDIA","quantity":"6.02","actualQuantity":"6.02","unit":"KGS","unitRateFc":"4558.1","totalValueFC":"27627.3","currency":"USD","unitRateINR":"385618.6","date":"03-Oct-2024","totalValueINR":"2321424","totalValueInUsd":"27627.3","indian_port":"Delhi Air","hs_no":"29419090","bill_no":"5937098","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HANGCHOW (HANGZHOU)","supplierAddress":"PRODUCTS IMPORT & EXPORT CO., LTD 6-7\/F,310 NORTH ZHONGSHAN ROAD HANGZHOU ,310003, CHINA","customerAddress":"Village Khara Khari, Ogli, Ogli,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1727893800,"product":"HEPARIN SODIUM IP2022","address":"Village Khara Khari, Ogli, Ogli,","city":"KALA AMB","supplier":"ZHEJIANG MEDICINE CO LTD","supplierCountry":"CHINA","foreign_port":"HANGCHOW (HANGZHOU)","customer":"NIXI LABORATORIES PRIVATE LIMITED","customerCountry":"INDIA","quantity":"6.88","actualQuantity":"6.88","unit":"KGS","unitRateFc":"4558.1","totalValueFC":"31574","currency":"USD","unitRateINR":"385618.6","date":"03-Oct-2024","totalValueINR":"2653056","totalValueInUsd":"31574","indian_port":"Delhi Air","hs_no":"29419090","bill_no":"5937098","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HANGCHOW (HANGZHOU)","supplierAddress":"PRODUCTS IMPORT & EXPORT CO., LTD 6-7\/F,310 NORTH ZHONGSHAN ROAD HANGZHOU ,310003, CHINA","customerAddress":"Village Khara Khari, Ogli, Ogli,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729017000,"product":"HEPARIN SODIUM IP(IMPORT LICENCE NO:IL\/BD\/014708 RC\/BD-002482 DT.24-MAY-2024)","address":"SCO.162-64, SECTOR 34-A,","city":"CHANDIGARH.","supplier":"YINO PHARMA LIMITED","supplierCountry":"CHINA","foreign_port":"CHONGQING","customer":"HEALTH BIOTECH","customerCountry":"INDIA","quantity":"1.68","actualQuantity":"1.678","unit":"KGS","unitRateFc":"4787.1","totalValueFC":"8111.5","currency":"USD","unitRateINR":"406185.4","date":"16-Oct-2024","totalValueINR":"681579.15","totalValueInUsd":"8111.5","indian_port":"Delhi Air","hs_no":"29349990","bill_no":"6142530","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"CHONGQING","supplierAddress":"2 CUIPING ERXIANG, YUBEI DISTRICT 4 01120, Chongqing, CHINA SDNF CHINA","customerAddress":"SCO.162-64, SECTOR 34-A,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729017000,"product":"HEPARIN SODIUM IP(IMPORT LICENCE NO:IL\/BD\/014708 RC\/BD-002482 DT.24-MAY-2024)","address":"SCO.162-64, SECTOR 34-A,","city":"CHANDIGARH.","supplier":"YINO PHARMA LIMITED","supplierCountry":"CHINA","foreign_port":"CHONGQING","customer":"HEALTH BIOTECH","customerCountry":"INDIA","quantity":"17.18","actualQuantity":"17.18","unit":"KGS","unitRateFc":"4787.1","totalValueFC":"83048.3","currency":"USD","unitRateINR":"406185.4","date":"16-Oct-2024","totalValueINR":"6978265.63","totalValueInUsd":"83048.3","indian_port":"Delhi Air","hs_no":"29349990","bill_no":"6142530","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"CHONGQING","supplierAddress":"2 CUIPING ERXIANG, YUBEI DISTRICT 4 01120, Chongqing, CHINA SDNF CHINA","customerAddress":"SCO.162-64, SECTOR 34-A,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729103400,"product":"HEPARIN SODIUM IP2022","address":"Village Khara Khari, Ogli, Ogli,","city":"KALA AMB","supplier":"ZHEJIANG MEDICINE CO LTD","supplierCountry":"CHINA","foreign_port":"HANGCHOW (HANGZHOU)","customer":"NIXI LABORATORIES PRIVATE LIMITED","customerCountry":"INDIA","quantity":"3.01","actualQuantity":"3.01","unit":"KGS","unitRateFc":"4558.1","totalValueFC":"13854.5","currency":"USD","unitRateINR":"386758.1","date":"17-Oct-2024","totalValueINR":"1164142","totalValueInUsd":"13854.5","indian_port":"Delhi Air","hs_no":"29419090","bill_no":"6183411","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HANGCHOW (HANGZHOU)","supplierAddress":"PRODUCTS IMPORT & EXPORT CO., LTD 6-7\/F,310 NORTH ZHONGSHAN ROAD HANGZHOU ,310003, CHINA","customerAddress":"Village Khara Khari, Ogli, Ogli,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1737397800,"product":"HEPARIN SODIUM IP 2022(LICENCE NO:IL\/BD-014708 RC\/BD-002482DT:20-MAY-2024)HEPARIN SODIUM IP 2022(LICENCE NO:IL\/BD-014708 RC\/BD-002482","address":"SCO.162-64, SECTOR 34-A,","city":"CHANDIGARH.","supplier":"YINO PHARMA LIMITED","supplierCountry":"CHINA","foreign_port":"CHONGQING","customer":"HEALTH BIOTECH","customerCountry":"INDIA","quantity":"4.75","actualQuantity":"4.75","unit":"KGS","unitRateFc":"4477","totalValueFC":"21480.5","currency":"USD","unitRateINR":"389946.7","date":"21-Jan-2025","totalValueINR":"1852246.83","totalValueInUsd":"21480.5","indian_port":"Delhi Air","hs_no":"29349990","bill_no":"7915209","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"CHONGQING","supplierAddress":"2 CUIPING ERXIANG, YUBEI DISTRICT 4 01120, Chongqing, CHINA SDNF","customerAddress":"SCO.162-64, SECTOR 34-A,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1737397800,"product":"HEPARIN SODIUM IP 2022(LICENCE NO:IL\/BD-014708 RC\/BD-002482DT:20-MAY-2024)HEPARIN SODIUM IP 2022(LICENCE NO:IL\/BD-014708 RC\/BD-002482","address":"SCO.162-64, SECTOR 34-A,","city":"CHANDIGARH.","supplier":"YINO PHARMA LIMITED","supplierCountry":"CHINA","foreign_port":"CHONGQING","customer":"HEALTH BIOTECH","customerCountry":"INDIA","quantity":"7.25","actualQuantity":"7.25","unit":"KGS","unitRateFc":"4477","totalValueFC":"32786","currency":"USD","unitRateINR":"389946.7","date":"21-Jan-2025","totalValueINR":"2827113.58","totalValueInUsd":"32786","indian_port":"Delhi Air","hs_no":"29349990","bill_no":"7915209","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"CHONGQING","supplierAddress":"2 CUIPING ERXIANG, YUBEI DISTRICT 4 01120, Chongqing, CHINA SDNF","customerAddress":"SCO.162-64, SECTOR 34-A,"}]
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21-Jan-2025
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DOSAGE - INJECTABLE;INJECTION - 1,000 UNITS/M...DOSAGE - INJECTABLE;INJECTION - 1,000 UNITS/ML

USFDA APPLICATION NUMBER - 17029

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USFDA APPLICATION NUMBER - 17029

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USFDA APPLICATION NUMBER - 17029

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USFDA APPLICATION NUMBER - 17029

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USFDA APPLICATION NUMBER - 17029

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DOSAGE - INJECTABLE;INJECTION - 1,000 UNITS/M...DOSAGE - INJECTABLE;INJECTION - 1,000 UNITS/ML

USFDA APPLICATION NUMBER - 201370

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USFDA APPLICATION NUMBER - 201370

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DOSAGE - INJECTABLE;INJECTION - 5,000 UNITS/M...DOSAGE - INJECTABLE;INJECTION - 5,000 UNITS/ML

USFDA APPLICATION NUMBER - 201370

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ABOUT THIS PAGE

Looking for / Heparin Sodium API manufacturers, exporters & distributors?

Heparin Sodium manufacturers, exporters & distributors 1

23

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

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

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

API | Excipient name

Heparin Sodium

Synonyms

(2s,3s,4r,5r,6r)-6-{[(2s,3s,4s,5r,6s)-6-{[(2r,3s,4s,5r)-2-carboxy-4,6-dihydroxy-5-(sulfooxy)oxan-3-yl]oxy}-2-hydroxy-4-(sulfomethyl)-5-(sulfooxy)oxan-3-yl]oxy}-3-{[(2r,3r,4r,5s,6r)-3-acetamido-4,5-dihydroxy-6-[(sulfooxy)methyl]oxan-2-yl]oxy}-4,5-dihydroxyoxane-2-carboxylic acid, Hepflush, Chembl526514, Gtpl4214, S01xa14, Bdbm50480251

About Heparin Sodium

A highly acidic mucopolysaccharide formed of equal parts of sulfated D-glucosamine and D-glucuronic acid with sulfaminic bridges. The molecular weight ranges from six to twenty thousand. Heparin occurs in and is obtained from liver, lung, mast cells, etc., of vertebrates. Its function is unknown, but it is used to prevent blood clotting in vivo and vitro, in the form of many different salts.

Heparin Sodium Manufacturers

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

Heparin Sodium Suppliers

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

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

Heparin Sodium USDMF

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

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

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

Heparin Sodium JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Heparin Sodium Drug Master File in Japan (Heparin Sodium JDMF) empowers Heparin Sodium API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Heparin Sodium JDMF during the approval evaluation for pharmaceutical products. At the time of Heparin Sodium JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Heparin Sodium suppliers with JDMF on PharmaCompass.

Heparin Sodium KDMF

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

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

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

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

Heparin Sodium CEP

A Heparin Sodium CEP of the European Pharmacopoeia monograph is often referred to as a Heparin Sodium Certificate of Suitability (COS). The purpose of a Heparin Sodium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Heparin Sodium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Heparin Sodium to their clients by showing that a Heparin Sodium CEP has been issued for it. The manufacturer submits a Heparin Sodium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Heparin Sodium CEP holder for the record. Additionally, the data presented in the Heparin Sodium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Heparin Sodium DMF.

A Heparin Sodium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Heparin Sodium CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Heparin Sodium suppliers with CEP (COS) on PharmaCompass.

Heparin Sodium WC

A Heparin Sodium written confirmation (Heparin Sodium WC) is an official document issued by a regulatory agency to a Heparin Sodium manufacturer, verifying that the manufacturing facility of a Heparin Sodium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Heparin Sodium APIs or Heparin Sodium finished pharmaceutical products to another nation, regulatory agencies frequently require a Heparin Sodium WC (written confirmation) as part of the regulatory process.

click here to find a list of Heparin Sodium suppliers with Written Confirmation (WC) on PharmaCompass.

Heparin Sodium 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 Heparin Sodium as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Heparin Sodium 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 Heparin Sodium 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 Heparin Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Heparin Sodium NDC to their finished compounded human drug products, they may choose to do so.

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

Heparin Sodium GMP

Heparin Sodium 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 Heparin Sodium 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 Heparin Sodium GMP manufacturer or Heparin Sodium GMP API supplier for your needs.

Heparin Sodium CoA

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

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

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