Synopsis
0
CEP/COS
0
EU WC
0
NDC API
0
VMF
0
Australia
DRUG PRODUCT COMPOSITIONS0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
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]Parenteral
Topical
Solubilizers
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
APIs
Reply
30 Jul 2025
Reply
08 Jun 2023
Reply
18 Mar 2023
Reply
03 Mar 2023
Reply
07 Feb 2023
Reply
24 Feb 2022
Reply
17 Sep 2021
Reply
29 Jan 2021
Reply
23 Sep 2019
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
REF. STANDARDS & IMPURITIES
Others
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]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 Tinzaparin sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tinzaparin sodium, including repackagers and relabelers. The FDA regulates Tinzaparin sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tinzaparin 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 Tinzaparin sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tinzaparin sodium supplier is an individual or a company that provides Tinzaparin sodium active pharmaceutical ingredient (API) or Tinzaparin sodium finished formulations upon request. The Tinzaparin sodium suppliers may include Tinzaparin sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Tinzaparin sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tinzaparin sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Tinzaparin sodium active pharmaceutical ingredient (API) in detail. Different forms of Tinzaparin sodium DMFs exist exist since differing nations have different regulations, such as Tinzaparin sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tinzaparin sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Tinzaparin sodium USDMF includes data on Tinzaparin sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tinzaparin sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tinzaparin 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 Tinzaparin sodium Drug Master File in Japan (Tinzaparin sodium JDMF) empowers Tinzaparin 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 Tinzaparin sodium JDMF during the approval evaluation for pharmaceutical products. At the time of Tinzaparin 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 Tinzaparin 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 Tinzaparin sodium Drug Master File in Korea (Tinzaparin sodium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Tinzaparin sodium. The MFDS reviews the Tinzaparin sodium KDMF as part of the drug registration process and uses the information provided in the Tinzaparin sodium KDMF to evaluate the safety and efficacy of the drug.
After submitting a Tinzaparin 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 Tinzaparin sodium API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Tinzaparin sodium suppliers with KDMF on PharmaCompass.
Tinzaparin 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 Tinzaparin sodium 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 Tinzaparin sodium GMP manufacturer or Tinzaparin sodium GMP API supplier for your needs.
A Tinzaparin sodium CoA (Certificate of Analysis) is a formal document that attests to Tinzaparin sodium's compliance with Tinzaparin sodium specifications and serves as a tool for batch-level quality control.
Tinzaparin sodium CoA mostly includes findings from lab analyses of a specific batch. For each Tinzaparin 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.
Tinzaparin sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Tinzaparin sodium EP), Tinzaparin sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tinzaparin sodium USP).
Comment (3)
