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