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API SUPPLIERS
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USDMF
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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]Kirsch Pharma
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
38
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 Heparin natrium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Heparin natrium, including repackagers and relabelers. The FDA regulates Heparin natrium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Heparin natrium 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 natrium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Heparin natrium supplier is an individual or a company that provides Heparin natrium active pharmaceutical ingredient (API) or Heparin natrium finished formulations upon request. The Heparin natrium suppliers may include Heparin natrium API manufacturers, exporters, distributors and traders.
click here to find a list of Heparin natrium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Heparin natrium DMF (Drug Master File) is a document detailing the whole manufacturing process of Heparin natrium active pharmaceutical ingredient (API) in detail. Different forms of Heparin natrium DMFs exist exist since differing nations have different regulations, such as Heparin natrium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Heparin natrium DMF submitted to regulatory agencies in the US is known as a USDMF. Heparin natrium USDMF includes data on Heparin natrium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Heparin natrium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Heparin natrium 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 natrium Drug Master File in Japan (Heparin natrium JDMF) empowers Heparin natrium 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 natrium JDMF during the approval evaluation for pharmaceutical products. At the time of Heparin natrium 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 natrium 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 natrium Drug Master File in Korea (Heparin natrium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Heparin natrium. The MFDS reviews the Heparin natrium KDMF as part of the drug registration process and uses the information provided in the Heparin natrium KDMF to evaluate the safety and efficacy of the drug.
After submitting a Heparin natrium 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 natrium API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Heparin natrium suppliers with KDMF on PharmaCompass.
Heparin natrium 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 natrium 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 natrium GMP manufacturer or Heparin natrium GMP API supplier for your needs.
A Heparin natrium CoA (Certificate of Analysis) is a formal document that attests to Heparin natrium's compliance with Heparin natrium specifications and serves as a tool for batch-level quality control.
Heparin natrium CoA mostly includes findings from lab analyses of a specific batch. For each Heparin natrium 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 natrium may be tested according to a variety of international standards, such as European Pharmacopoeia (Heparin natrium EP), Heparin natrium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Heparin natrium USP).
