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Bioiberica is a global life science company committed to improving the health & wellbeing of people, animals & plants.
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NDC
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Aspen API. More than just an API™
NDC
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
Bioiberica is a global life science company committed to improving the health & wellbeing of people, animals & plants.
Bioiberica is a global life science company committed to improving the health & wellbeing of people, animals & plants.
Aspen API. More than just an API™
NDC
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USDMF
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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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ABOUT THIS PAGE
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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.
A Heparin, Unfractionated manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Heparin, Unfractionated, including repackagers and relabelers. The FDA regulates Heparin, Unfractionated manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Heparin, Unfractionated 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, Unfractionated manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Heparin, Unfractionated supplier is an individual or a company that provides Heparin, Unfractionated active pharmaceutical ingredient (API) or Heparin, Unfractionated finished formulations upon request. The Heparin, Unfractionated suppliers may include Heparin, Unfractionated API manufacturers, exporters, distributors and traders.
click here to find a list of Heparin, Unfractionated suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Heparin, Unfractionated DMF (Drug Master File) is a document detailing the whole manufacturing process of Heparin, Unfractionated active pharmaceutical ingredient (API) in detail. Different forms of Heparin, Unfractionated DMFs exist exist since differing nations have different regulations, such as Heparin, Unfractionated USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Heparin, Unfractionated DMF submitted to regulatory agencies in the US is known as a USDMF. Heparin, Unfractionated USDMF includes data on Heparin, Unfractionated's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Heparin, Unfractionated USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Heparin, Unfractionated 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, Unfractionated Drug Master File in Japan (Heparin, Unfractionated JDMF) empowers Heparin, Unfractionated 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, Unfractionated JDMF during the approval evaluation for pharmaceutical products. At the time of Heparin, Unfractionated 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, Unfractionated 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, Unfractionated Drug Master File in Korea (Heparin, Unfractionated KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Heparin, Unfractionated. The MFDS reviews the Heparin, Unfractionated KDMF as part of the drug registration process and uses the information provided in the Heparin, Unfractionated KDMF to evaluate the safety and efficacy of the drug.
After submitting a Heparin, Unfractionated 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, Unfractionated API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Heparin, Unfractionated suppliers with KDMF on PharmaCompass.
A Heparin, Unfractionated CEP of the European Pharmacopoeia monograph is often referred to as a Heparin, Unfractionated Certificate of Suitability (COS). The purpose of a Heparin, Unfractionated CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Heparin, Unfractionated EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Heparin, Unfractionated to their clients by showing that a Heparin, Unfractionated CEP has been issued for it. The manufacturer submits a Heparin, Unfractionated CEP (COS) as part of the market authorization procedure, and it takes on the role of a Heparin, Unfractionated CEP holder for the record. Additionally, the data presented in the Heparin, Unfractionated CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Heparin, Unfractionated DMF.
A Heparin, Unfractionated CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Heparin, Unfractionated 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, Unfractionated suppliers with CEP (COS) 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, Unfractionated as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Heparin, Unfractionated 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, Unfractionated 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, Unfractionated and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Heparin, Unfractionated NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Heparin, Unfractionated suppliers with NDC on PharmaCompass.
Heparin, Unfractionated 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, Unfractionated 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, Unfractionated GMP manufacturer or Heparin, Unfractionated GMP API supplier for your needs.
A Heparin, Unfractionated CoA (Certificate of Analysis) is a formal document that attests to Heparin, Unfractionated's compliance with Heparin, Unfractionated specifications and serves as a tool for batch-level quality control.
Heparin, Unfractionated CoA mostly includes findings from lab analyses of a specific batch. For each Heparin, Unfractionated 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, Unfractionated may be tested according to a variety of international standards, such as European Pharmacopoeia (Heparin, Unfractionated EP), Heparin, Unfractionated JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Heparin, Unfractionated USP).
