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API SUPPLIERS
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USDMF
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Drugs in Development
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DOSAGE - INJECTABLE;INJECTION - 1,000 UNITS/M...DOSAGE - INJECTABLE;INJECTION - 1,000 UNITS/ML
USFDA APPLICATION NUMBER - 17029
DOSAGE - INJECTABLE;INJECTION - 10,000 UNITS/...DOSAGE - INJECTABLE;INJECTION - 10,000 UNITS/ML
USFDA APPLICATION NUMBER - 17029
DOSAGE - INJECTABLE;INJECTION - 100 UNITS/ML
USFDA APPLICATION NUMBER - 17029
DOSAGE - INJECTABLE;INJECTION - 20,000 UNITS/...DOSAGE - INJECTABLE;INJECTION - 20,000 UNITS/ML
USFDA APPLICATION NUMBER - 17029
DOSAGE - INJECTABLE;INJECTION - 40 UNITS/ML
USFDA APPLICATION NUMBER - 17029
DOSAGE - INJECTABLE;INJECTION - 5,000 UNITS/M...DOSAGE - INJECTABLE;INJECTION - 5,000 UNITS/ML
USFDA APPLICATION NUMBER - 17029
DOSAGE - INJECTABLE;INJECTION - 50 UNITS/ML
USFDA APPLICATION NUMBER - 17029
DOSAGE - INJECTABLE;INJECTION - 1,000 UNITS/M...DOSAGE - INJECTABLE;INJECTION - 1,000 UNITS/ML
USFDA APPLICATION NUMBER - 201370
DOSAGE - INJECTABLE;INJECTION - 10,000 UNITS/...DOSAGE - INJECTABLE;INJECTION - 10,000 UNITS/ML
USFDA APPLICATION NUMBER - 201370
DOSAGE - INJECTABLE;INJECTION - 5,000 UNITS/M...DOSAGE - INJECTABLE;INJECTION - 5,000 UNITS/ML
USFDA APPLICATION NUMBER - 201370
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REF. STANDARDS & IMPURITIES
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ANALYTICAL
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ABOUT THIS PAGE
A Heparin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Heparin, including repackagers and relabelers. The FDA regulates Heparin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Heparin 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Heparin supplier is an individual or a company that provides Heparin active pharmaceutical ingredient (API) or Heparin finished formulations upon request. The Heparin suppliers may include Heparin API manufacturers, exporters, distributors and traders.
click here to find a list of Heparin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Heparin DMF (Drug Master File) is a document detailing the whole manufacturing process of Heparin active pharmaceutical ingredient (API) in detail. Different forms of Heparin DMFs exist exist since differing nations have different regulations, such as Heparin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Heparin DMF submitted to regulatory agencies in the US is known as a USDMF. Heparin USDMF includes data on Heparin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Heparin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Heparin suppliers with USDMF on PharmaCompass.
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 Drug Master File in Japan (Heparin JDMF) empowers Heparin 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 JDMF during the approval evaluation for pharmaceutical products. At the time of Heparin 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 suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Heparin Drug Master File in Korea (Heparin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Heparin. The MFDS reviews the Heparin KDMF as part of the drug registration process and uses the information provided in the Heparin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Heparin 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 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Heparin suppliers with KDMF on PharmaCompass.
A Heparin CEP of the European Pharmacopoeia monograph is often referred to as a Heparin Certificate of Suitability (COS). The purpose of a Heparin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Heparin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Heparin to their clients by showing that a Heparin CEP has been issued for it. The manufacturer submits a Heparin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Heparin CEP holder for the record. Additionally, the data presented in the Heparin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Heparin DMF.
A Heparin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Heparin 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 suppliers with CEP (COS) on PharmaCompass.
A Heparin written confirmation (Heparin WC) is an official document issued by a regulatory agency to a Heparin manufacturer, verifying that the manufacturing facility of a Heparin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Heparin APIs or Heparin finished pharmaceutical products to another nation, regulatory agencies frequently require a Heparin WC (written confirmation) as part of the regulatory process.
click here to find a list of Heparin suppliers with Written Confirmation (WC) on PharmaCompass.
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 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Heparin API and other APIs are published in this directory by the FDA.
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 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.
The NDC directory also contains data on finished compounded human drug products that contain Heparin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Heparin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Heparin suppliers with NDC on PharmaCompass.
Heparin 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 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 GMP manufacturer or Heparin GMP API supplier for your needs.
A Heparin CoA (Certificate of Analysis) is a formal document that attests to Heparin's compliance with Heparin specifications and serves as a tool for batch-level quality control.
Heparin CoA mostly includes findings from lab analyses of a specific batch. For each Heparin 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Heparin EP), Heparin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Heparin USP).
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