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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, 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 Lioton 1000 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lioton 1000, including repackagers and relabelers. The FDA regulates Lioton 1000 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lioton 1000 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 Lioton 1000 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Lioton 1000 supplier is an individual or a company that provides Lioton 1000 active pharmaceutical ingredient (API) or Lioton 1000 finished formulations upon request. The Lioton 1000 suppliers may include Lioton 1000 API manufacturers, exporters, distributors and traders.
click here to find a list of Lioton 1000 suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Lioton 1000 DMF (Drug Master File) is a document detailing the whole manufacturing process of Lioton 1000 active pharmaceutical ingredient (API) in detail. Different forms of Lioton 1000 DMFs exist exist since differing nations have different regulations, such as Lioton 1000 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lioton 1000 DMF submitted to regulatory agencies in the US is known as a USDMF. Lioton 1000 USDMF includes data on Lioton 1000's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lioton 1000 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lioton 1000 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 Lioton 1000 Drug Master File in Japan (Lioton 1000 JDMF) empowers Lioton 1000 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 Lioton 1000 JDMF during the approval evaluation for pharmaceutical products. At the time of Lioton 1000 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 Lioton 1000 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 Lioton 1000 Drug Master File in Korea (Lioton 1000 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Lioton 1000. The MFDS reviews the Lioton 1000 KDMF as part of the drug registration process and uses the information provided in the Lioton 1000 KDMF to evaluate the safety and efficacy of the drug.
After submitting a Lioton 1000 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 Lioton 1000 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Lioton 1000 suppliers with KDMF on PharmaCompass.
Lioton 1000 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 Lioton 1000 GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Lioton 1000 GMP manufacturer or Lioton 1000 GMP API supplier for your needs.
A Lioton 1000 CoA (Certificate of Analysis) is a formal document that attests to Lioton 1000's compliance with Lioton 1000 specifications and serves as a tool for batch-level quality control.
Lioton 1000 CoA mostly includes findings from lab analyses of a specific batch. For each Lioton 1000 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.
Lioton 1000 may be tested according to a variety of international standards, such as European Pharmacopoeia (Lioton 1000 EP), Lioton 1000 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lioton 1000 USP).
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