Synopsis
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CEP/COS
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KDMF
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NDC API
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VMF
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Australia
DRUG PRODUCT COMPOSITIONS0
US Patents
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US Exclusivities
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Health Canada Patents
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
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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Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Cream / Lotion / Ointment, Gel, Injectable / Parenteral, Tablet
Grade : Parenteral, Oral, Topical
Application : Parenteral, Solubilizers, Topical
Excipient Details : Benzyl alcohol is used as a bacteriostatic & preservative in parenteral & ophthalmic products. It is widely used in oral & topical formulations.
Topical
Solubilizers
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Cream / Lotion / Ointment, Gel, Injectable / Parenteral, Tablet
Grade : Parenteral, Oral, Topical
Application : Parenteral, Solubilizers, Topical
Excipient Details : Benzyl alcohol is used as a bacteriostatic & preservative in parenteral & ophthalmic products. It is widely used in oral & topical formulations.
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Nadroparin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nadroparin, including repackagers and relabelers. The FDA regulates Nadroparin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nadroparin 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 Nadroparin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nadroparin supplier is an individual or a company that provides Nadroparin active pharmaceutical ingredient (API) or Nadroparin finished formulations upon request. The Nadroparin suppliers may include Nadroparin API manufacturers, exporters, distributors and traders.
click here to find a list of Nadroparin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nadroparin DMF (Drug Master File) is a document detailing the whole manufacturing process of Nadroparin active pharmaceutical ingredient (API) in detail. Different forms of Nadroparin DMFs exist exist since differing nations have different regulations, such as Nadroparin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nadroparin DMF submitted to regulatory agencies in the US is known as a USDMF. Nadroparin USDMF includes data on Nadroparin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nadroparin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nadroparin 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 Nadroparin Drug Master File in Japan (Nadroparin JDMF) empowers Nadroparin 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 Nadroparin JDMF during the approval evaluation for pharmaceutical products. At the time of Nadroparin 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 Nadroparin suppliers with JDMF on PharmaCompass.
A Nadroparin written confirmation (Nadroparin WC) is an official document issued by a regulatory agency to a Nadroparin manufacturer, verifying that the manufacturing facility of a Nadroparin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Nadroparin APIs or Nadroparin finished pharmaceutical products to another nation, regulatory agencies frequently require a Nadroparin WC (written confirmation) as part of the regulatory process.
click here to find a list of Nadroparin suppliers with Written Confirmation (WC) on PharmaCompass.
Nadroparin 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 Nadroparin 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 Nadroparin GMP manufacturer or Nadroparin GMP API supplier for your needs.
A Nadroparin CoA (Certificate of Analysis) is a formal document that attests to Nadroparin's compliance with Nadroparin specifications and serves as a tool for batch-level quality control.
Nadroparin CoA mostly includes findings from lab analyses of a specific batch. For each Nadroparin 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.
Nadroparin may be tested according to a variety of international standards, such as European Pharmacopoeia (Nadroparin EP), Nadroparin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Nadroparin USP).
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