Synopsis
0
VMF
DRUG PRODUCT COMPOSITIONS0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
Bioiberica is a global life science company committed to improving the health & wellbeing of people, animals & plants.
Click Us!
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
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
Related Excipient Companies
Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Parenteral
Fillers, Diluents & Binders
Topical
Controlled & Modified Release
Co-Processed Excipients
Taste Masking
Solubilizers
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
REF. STANDARDS & IMPURITIES
ANALYTICAL
Analytical Methods
ABOUT THIS PAGE
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
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.
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 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.
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).
