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API SUPPLIERS
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USDMF
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9939
Submission : 1992-11-02
Status :
Type : II
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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
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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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, 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 Nadroparine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nadroparine, including repackagers and relabelers. The FDA regulates Nadroparine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nadroparine 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 Nadroparine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nadroparine supplier is an individual or a company that provides Nadroparine active pharmaceutical ingredient (API) or Nadroparine finished formulations upon request. The Nadroparine suppliers may include Nadroparine API manufacturers, exporters, distributors and traders.
click here to find a list of Nadroparine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nadroparine DMF (Drug Master File) is a document detailing the whole manufacturing process of Nadroparine active pharmaceutical ingredient (API) in detail. Different forms of Nadroparine DMFs exist exist since differing nations have different regulations, such as Nadroparine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nadroparine DMF submitted to regulatory agencies in the US is known as a USDMF. Nadroparine USDMF includes data on Nadroparine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nadroparine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nadroparine 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 Nadroparine Drug Master File in Japan (Nadroparine JDMF) empowers Nadroparine 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 Nadroparine JDMF during the approval evaluation for pharmaceutical products. At the time of Nadroparine 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 Nadroparine 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 Nadroparine Drug Master File in Korea (Nadroparine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Nadroparine. The MFDS reviews the Nadroparine KDMF as part of the drug registration process and uses the information provided in the Nadroparine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Nadroparine 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 Nadroparine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Nadroparine suppliers with KDMF on PharmaCompass.
Nadroparine 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 Nadroparine 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 Nadroparine GMP manufacturer or Nadroparine GMP API supplier for your needs.
A Nadroparine CoA (Certificate of Analysis) is a formal document that attests to Nadroparine's compliance with Nadroparine specifications and serves as a tool for batch-level quality control.
Nadroparine CoA mostly includes findings from lab analyses of a specific batch. For each Nadroparine 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.
Nadroparine may be tested according to a variety of international standards, such as European Pharmacopoeia (Nadroparine EP), Nadroparine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Nadroparine USP).
