Synopsis
0
CEP/COS
0
KDMF
0
NDC API
0
VMF
0
Australia
DRUG PRODUCT COMPOSITIONS0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
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]EU WC
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]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]DRUG PRODUCT COMPOSITIONS
DOSAGE - INJECTABLE;SUBCUTANEOUS - 10,000IU/M...DOSAGE - INJECTABLE;SUBCUTANEOUS - 10,000IU/ML (10,000IU/ML)
USFDA APPLICATION NUMBER - 20287
DOSAGE - INJECTABLE;SUBCUTANEOUS - 10,000IU/4...DOSAGE - INJECTABLE;SUBCUTANEOUS - 10,000IU/4ML (2,500IU/ML)
USFDA APPLICATION NUMBER - 20287
DOSAGE - INJECTABLE;SUBCUTANEOUS - 12,500IU/0...DOSAGE - INJECTABLE;SUBCUTANEOUS - 12,500IU/0.5ML (25,000IU/ML)
USFDA APPLICATION NUMBER - 20287
DOSAGE - INJECTABLE;SUBCUTANEOUS - 15,000IU/0...DOSAGE - INJECTABLE;SUBCUTANEOUS - 15,000IU/0.6ML (25,000IU/ML)
USFDA APPLICATION NUMBER - 20287
DOSAGE - INJECTABLE;SUBCUTANEOUS - 18,000IU/0...DOSAGE - INJECTABLE;SUBCUTANEOUS - 18,000IU/0.72ML (25,000IU/ML)
USFDA APPLICATION NUMBER - 20287
DOSAGE - INJECTABLE;SUBCUTANEOUS - 2,500IU/0....DOSAGE - INJECTABLE;SUBCUTANEOUS - 2,500IU/0.2ML (12,500IU/ML)
USFDA APPLICATION NUMBER - 20287
DOSAGE - INJECTABLE;SUBCUTANEOUS - 5,000IU/0....DOSAGE - INJECTABLE;SUBCUTANEOUS - 5,000IU/0.2ML (25,000IU/ML)
USFDA APPLICATION NUMBER - 20287
DOSAGE - INJECTABLE;SUBCUTANEOUS - 7,500IU/0....DOSAGE - INJECTABLE;SUBCUTANEOUS - 7,500IU/0.3ML (25,000IU/ML)
USFDA APPLICATION NUMBER - 20287
DOSAGE - INJECTABLE;SUBCUTANEOUS - 95,000IU/3...DOSAGE - INJECTABLE;SUBCUTANEOUS - 95,000IU/3.8ML (25,000IU/ML)
USFDA APPLICATION NUMBER - 20287
Related Excipient Companies
Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Parenteral
Topical
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
ABOUT THIS PAGE
20
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.
A Dalteparin sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dalteparin sodium, including repackagers and relabelers. The FDA regulates Dalteparin sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dalteparin 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 Dalteparin sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dalteparin sodium supplier is an individual or a company that provides Dalteparin sodium active pharmaceutical ingredient (API) or Dalteparin sodium finished formulations upon request. The Dalteparin sodium suppliers may include Dalteparin sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Dalteparin sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dalteparin sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Dalteparin sodium active pharmaceutical ingredient (API) in detail. Different forms of Dalteparin sodium DMFs exist exist since differing nations have different regulations, such as Dalteparin sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dalteparin sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Dalteparin sodium USDMF includes data on Dalteparin sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dalteparin sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dalteparin 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 Dalteparin sodium Drug Master File in Japan (Dalteparin sodium JDMF) empowers Dalteparin 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 Dalteparin sodium JDMF during the approval evaluation for pharmaceutical products. At the time of Dalteparin 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 Dalteparin sodium suppliers with JDMF on PharmaCompass.
A Dalteparin sodium written confirmation (Dalteparin sodium WC) is an official document issued by a regulatory agency to a Dalteparin sodium manufacturer, verifying that the manufacturing facility of a Dalteparin sodium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Dalteparin sodium APIs or Dalteparin sodium finished pharmaceutical products to another nation, regulatory agencies frequently require a Dalteparin sodium WC (written confirmation) as part of the regulatory process.
click here to find a list of Dalteparin sodium suppliers with Written Confirmation (WC) on PharmaCompass.
Dalteparin 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 Dalteparin 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 Dalteparin sodium GMP manufacturer or Dalteparin sodium GMP API supplier for your needs.
A Dalteparin sodium CoA (Certificate of Analysis) is a formal document that attests to Dalteparin sodium's compliance with Dalteparin sodium specifications and serves as a tool for batch-level quality control.
Dalteparin sodium CoA mostly includes findings from lab analyses of a specific batch. For each Dalteparin 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.
Dalteparin sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Dalteparin sodium EP), Dalteparin sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dalteparin sodium USP).
