Find Dalteparin sodium manufacturers, exporters & distributors on PharmaCompass

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Synopsis

Synopsis

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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

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

read-more

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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Looking for / Dalteparin sodium API manufacturers, exporters & distributors?

Dalteparin sodium manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Dalteparin sodium

Heparin sodium 2,000 units in dextrose 5% in plastic container Manufacturers

A Heparin sodium 2,000 units in dextrose 5% in plastic container manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Heparin sodium 2,000 units in dextrose 5% in plastic container, including repackagers and relabelers. The FDA regulates Heparin sodium 2,000 units in dextrose 5% in plastic container manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Heparin sodium 2,000 units in dextrose 5% in plastic container 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 2,000 units in dextrose 5% in plastic container manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Heparin sodium 2,000 units in dextrose 5% in plastic container Suppliers

A Heparin sodium 2,000 units in dextrose 5% in plastic container supplier is an individual or a company that provides Heparin sodium 2,000 units in dextrose 5% in plastic container active pharmaceutical ingredient (API) or Heparin sodium 2,000 units in dextrose 5% in plastic container finished formulations upon request. The Heparin sodium 2,000 units in dextrose 5% in plastic container suppliers may include Heparin sodium 2,000 units in dextrose 5% in plastic container API manufacturers, exporters, distributors and traders.

click here to find a list of Heparin sodium 2,000 units in dextrose 5% in plastic container suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Heparin sodium 2,000 units in dextrose 5% in plastic container USDMF

A Heparin sodium 2,000 units in dextrose 5% in plastic container DMF (Drug Master File) is a document detailing the whole manufacturing process of Heparin sodium 2,000 units in dextrose 5% in plastic container active pharmaceutical ingredient (API) in detail. Different forms of Heparin sodium 2,000 units in dextrose 5% in plastic container DMFs exist exist since differing nations have different regulations, such as Heparin sodium 2,000 units in dextrose 5% in plastic container USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Heparin sodium 2,000 units in dextrose 5% in plastic container DMF submitted to regulatory agencies in the US is known as a USDMF. Heparin sodium 2,000 units in dextrose 5% in plastic container USDMF includes data on Heparin sodium 2,000 units in dextrose 5% in plastic container's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Heparin sodium 2,000 units in dextrose 5% in plastic container USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Heparin sodium 2,000 units in dextrose 5% in plastic container suppliers with USDMF on PharmaCompass.

Heparin sodium 2,000 units in dextrose 5% in plastic container 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 2,000 units in dextrose 5% in plastic container Drug Master File in Japan (Heparin sodium 2,000 units in dextrose 5% in plastic container JDMF) empowers Heparin sodium 2,000 units in dextrose 5% in plastic container 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 2,000 units in dextrose 5% in plastic container JDMF during the approval evaluation for pharmaceutical products. At the time of Heparin sodium 2,000 units in dextrose 5% in plastic container 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 2,000 units in dextrose 5% in plastic container suppliers with JDMF on PharmaCompass.

Heparin sodium 2,000 units in dextrose 5% in plastic container 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 2,000 units in dextrose 5% in plastic container Drug Master File in Korea (Heparin sodium 2,000 units in dextrose 5% in plastic container KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Heparin sodium 2,000 units in dextrose 5% in plastic container. The MFDS reviews the Heparin sodium 2,000 units in dextrose 5% in plastic container KDMF as part of the drug registration process and uses the information provided in the Heparin sodium 2,000 units in dextrose 5% in plastic container KDMF to evaluate the safety and efficacy of the drug.

After submitting a Heparin sodium 2,000 units in dextrose 5% in plastic container 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 2,000 units in dextrose 5% in plastic container API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Heparin sodium 2,000 units in dextrose 5% in plastic container suppliers with KDMF on PharmaCompass.

Heparin sodium 2,000 units in dextrose 5% in plastic container WC

A Heparin sodium 2,000 units in dextrose 5% in plastic container written confirmation (Heparin sodium 2,000 units in dextrose 5% in plastic container WC) is an official document issued by a regulatory agency to a Heparin sodium 2,000 units in dextrose 5% in plastic container manufacturer, verifying that the manufacturing facility of a Heparin sodium 2,000 units in dextrose 5% in plastic container active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Heparin sodium 2,000 units in dextrose 5% in plastic container APIs or Heparin sodium 2,000 units in dextrose 5% in plastic container finished pharmaceutical products to another nation, regulatory agencies frequently require a Heparin sodium 2,000 units in dextrose 5% in plastic container WC (written confirmation) as part of the regulatory process.

click here to find a list of Heparin sodium 2,000 units in dextrose 5% in plastic container suppliers with Written Confirmation (WC) on PharmaCompass.

Heparin sodium 2,000 units in dextrose 5% in plastic container GMP

Heparin sodium 2,000 units in dextrose 5% in plastic container 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 2,000 units in dextrose 5% in plastic container 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 2,000 units in dextrose 5% in plastic container GMP manufacturer or Heparin sodium 2,000 units in dextrose 5% in plastic container GMP API supplier for your needs.

Heparin sodium 2,000 units in dextrose 5% in plastic container CoA

A Heparin sodium 2,000 units in dextrose 5% in plastic container CoA (Certificate of Analysis) is a formal document that attests to Heparin sodium 2,000 units in dextrose 5% in plastic container's compliance with Heparin sodium 2,000 units in dextrose 5% in plastic container specifications and serves as a tool for batch-level quality control.

Heparin sodium 2,000 units in dextrose 5% in plastic container CoA mostly includes findings from lab analyses of a specific batch. For each Heparin sodium 2,000 units in dextrose 5% in plastic container 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 2,000 units in dextrose 5% in plastic container may be tested according to a variety of international standards, such as European Pharmacopoeia (Heparin sodium 2,000 units in dextrose 5% in plastic container EP), Heparin sodium 2,000 units in dextrose 5% in plastic container JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Heparin sodium 2,000 units in dextrose 5% in plastic container 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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