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API SUPPLIERS
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USDMF
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DOSAGE - TABLET;ORAL - 100MG **Federal Regist...DOSAGE - TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 18830
DOSAGE - TABLET;ORAL - 150MG **Federal Regist...DOSAGE - TABLET;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 18830
DOSAGE - TABLET;ORAL - 50MG **Federal Registe...DOSAGE - TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 18830
Related Excipient Companies
Minakem
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Flecainide 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 Flecainide manufacturer or Flecainide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Flecainide manufacturer or Flecainide supplier.
PharmaCompass also assists you with knowing the Flecainide API Price utilized in the formulation of products. Flecainide API Price is not always fixed or binding as the Flecainide Price is obtained through a variety of data sources. The Flecainide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Tambocor manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tambocor, including repackagers and relabelers. The FDA regulates Tambocor manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tambocor 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 Tambocor manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tambocor supplier is an individual or a company that provides Tambocor active pharmaceutical ingredient (API) or Tambocor finished formulations upon request. The Tambocor suppliers may include Tambocor API manufacturers, exporters, distributors and traders.
click here to find a list of Tambocor suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tambocor DMF (Drug Master File) is a document detailing the whole manufacturing process of Tambocor active pharmaceutical ingredient (API) in detail. Different forms of Tambocor DMFs exist exist since differing nations have different regulations, such as Tambocor USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tambocor DMF submitted to regulatory agencies in the US is known as a USDMF. Tambocor USDMF includes data on Tambocor's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tambocor USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tambocor 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 Tambocor Drug Master File in Japan (Tambocor JDMF) empowers Tambocor 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 Tambocor JDMF during the approval evaluation for pharmaceutical products. At the time of Tambocor 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 Tambocor 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 Tambocor Drug Master File in Korea (Tambocor KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Tambocor. The MFDS reviews the Tambocor KDMF as part of the drug registration process and uses the information provided in the Tambocor KDMF to evaluate the safety and efficacy of the drug.
After submitting a Tambocor 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 Tambocor API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Tambocor suppliers with KDMF on PharmaCompass.
A Tambocor CEP of the European Pharmacopoeia monograph is often referred to as a Tambocor Certificate of Suitability (COS). The purpose of a Tambocor CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Tambocor EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Tambocor to their clients by showing that a Tambocor CEP has been issued for it. The manufacturer submits a Tambocor CEP (COS) as part of the market authorization procedure, and it takes on the role of a Tambocor CEP holder for the record. Additionally, the data presented in the Tambocor CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Tambocor DMF.
A Tambocor CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Tambocor 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 Tambocor suppliers with CEP (COS) on PharmaCompass.
A Tambocor written confirmation (Tambocor WC) is an official document issued by a regulatory agency to a Tambocor manufacturer, verifying that the manufacturing facility of a Tambocor active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Tambocor APIs or Tambocor finished pharmaceutical products to another nation, regulatory agencies frequently require a Tambocor WC (written confirmation) as part of the regulatory process.
click here to find a list of Tambocor suppliers with Written Confirmation (WC) 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 Tambocor as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tambocor 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 Tambocor 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 Tambocor and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tambocor NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tambocor suppliers with NDC on PharmaCompass.
Tambocor 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 Tambocor 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 Tambocor GMP manufacturer or Tambocor GMP API supplier for your needs.
A Tambocor CoA (Certificate of Analysis) is a formal document that attests to Tambocor's compliance with Tambocor specifications and serves as a tool for batch-level quality control.
Tambocor CoA mostly includes findings from lab analyses of a specific batch. For each Tambocor 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.
Tambocor may be tested according to a variety of international standards, such as European Pharmacopoeia (Tambocor EP), Tambocor JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tambocor USP).
