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API SUPPLIERS
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USDMF
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
GDUFA
DMF Review : Complete
Rev. Date : 2016-04-23
Pay. Date : 2016-03-23
DMF Number : 14619
Submission : 1999-12-13
Status :
Type : II
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Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
Certificate Number : R1-CEP 2011-342 - Rev 00
Status : Valid
Issue Date : 2018-08-06
Type : Chemical
Substance Number : 2107
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] JDMF
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
Registration Number : 303MF10150
Registrant's Address : Rue Fonds Jean Pa(^)ques, 8 1435 Mont-Saint-Guibert Belgium
Initial Date of Registration : 2021-09-17
Latest Date of Registration : 2021-09-17
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ABOUT THIS PAGE
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PharmaCompass offers a list of Vinorelbine Tartrate 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 Vinorelbine Tartrate manufacturer or Vinorelbine Tartrate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Vinorelbine Tartrate manufacturer or Vinorelbine Tartrate supplier.
PharmaCompass also assists you with knowing the Vinorelbine Tartrate API Price utilized in the formulation of products. Vinorelbine Tartrate API Price is not always fixed or binding as the Vinorelbine Tartrate Price is obtained through a variety of data sources. The Vinorelbine Tartrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Vinorelbine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vinorelbine, including repackagers and relabelers. The FDA regulates Vinorelbine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vinorelbine 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 Vinorelbine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Vinorelbine supplier is an individual or a company that provides Vinorelbine active pharmaceutical ingredient (API) or Vinorelbine finished formulations upon request. The Vinorelbine suppliers may include Vinorelbine API manufacturers, exporters, distributors and traders.
click here to find a list of Vinorelbine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Vinorelbine DMF (Drug Master File) is a document detailing the whole manufacturing process of Vinorelbine active pharmaceutical ingredient (API) in detail. Different forms of Vinorelbine DMFs exist exist since differing nations have different regulations, such as Vinorelbine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Vinorelbine DMF submitted to regulatory agencies in the US is known as a USDMF. Vinorelbine USDMF includes data on Vinorelbine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Vinorelbine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Vinorelbine 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 Vinorelbine Drug Master File in Japan (Vinorelbine JDMF) empowers Vinorelbine 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 Vinorelbine JDMF during the approval evaluation for pharmaceutical products. At the time of Vinorelbine 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 Vinorelbine 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 Vinorelbine Drug Master File in Korea (Vinorelbine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Vinorelbine. The MFDS reviews the Vinorelbine KDMF as part of the drug registration process and uses the information provided in the Vinorelbine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Vinorelbine 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 Vinorelbine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Vinorelbine suppliers with KDMF on PharmaCompass.
A Vinorelbine CEP of the European Pharmacopoeia monograph is often referred to as a Vinorelbine Certificate of Suitability (COS). The purpose of a Vinorelbine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Vinorelbine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Vinorelbine to their clients by showing that a Vinorelbine CEP has been issued for it. The manufacturer submits a Vinorelbine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Vinorelbine CEP holder for the record. Additionally, the data presented in the Vinorelbine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Vinorelbine DMF.
A Vinorelbine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Vinorelbine CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Vinorelbine suppliers with CEP (COS) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Vinorelbine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Vinorelbine API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Vinorelbine as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Vinorelbine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Vinorelbine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Vinorelbine suppliers with NDC on PharmaCompass.
Vinorelbine 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 Vinorelbine 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 Vinorelbine GMP manufacturer or Vinorelbine GMP API supplier for your needs.
A Vinorelbine CoA (Certificate of Analysis) is a formal document that attests to Vinorelbine's compliance with Vinorelbine specifications and serves as a tool for batch-level quality control.
Vinorelbine CoA mostly includes findings from lab analyses of a specific batch. For each Vinorelbine 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.
Vinorelbine may be tested according to a variety of international standards, such as European Pharmacopoeia (Vinorelbine EP), Vinorelbine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Vinorelbine USP).
