Synopsis
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VMF
DRUG PRODUCT COMPOSITIONS0
FDF
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API SUPPLIERS
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USDMF
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2014-12-05
Pay. Date : 2012-11-08
DMF Number : 18112
Submission : 2005-02-23
Status :
Type : II
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Capital Farma, a leading European pharmaceutical company focusing on the development & distribution of niche APIs & Pharma Services.
About the Company : Capital Farma offers a comprehensive range of pharmaceutical solutions. Our API offering includes active ingredients sourced exclusively from top European manufacturers, ensuring t...
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
About the Company : MINAKEM is a cGMP custom manufacturer of small molecule API, HPAPI and steroids. All development and manufacturing activities are supported by highly skilled R&D teams, supported b...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
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API Imports and Exports
Drugs in Development
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DOSAGE - TABLET;ORAL - EQ 12MG BASE **Federal...DOSAGE - TABLET;ORAL - EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21169
DOSAGE - TABLET;ORAL - EQ 4MG BASE **Federal ...DOSAGE - TABLET;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21169
DOSAGE - TABLET;ORAL - EQ 8MG BASE **Federal ...DOSAGE - TABLET;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21169
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ ...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ 16MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21615
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ ...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21615
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ ...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21615
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Galantamine Hydrobromide 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 Galantamine Hydrobromide manufacturer or Galantamine Hydrobromide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Galantamine Hydrobromide manufacturer or Galantamine Hydrobromide supplier.
PharmaCompass also assists you with knowing the Galantamine Hydrobromide API Price utilized in the formulation of products. Galantamine Hydrobromide API Price is not always fixed or binding as the Galantamine Hydrobromide Price is obtained through a variety of data sources. The Galantamine Hydrobromide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Reminyl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Reminyl, including repackagers and relabelers. The FDA regulates Reminyl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Reminyl 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 Reminyl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Reminyl supplier is an individual or a company that provides Reminyl active pharmaceutical ingredient (API) or Reminyl finished formulations upon request. The Reminyl suppliers may include Reminyl API manufacturers, exporters, distributors and traders.
click here to find a list of Reminyl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Reminyl DMF (Drug Master File) is a document detailing the whole manufacturing process of Reminyl active pharmaceutical ingredient (API) in detail. Different forms of Reminyl DMFs exist exist since differing nations have different regulations, such as Reminyl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Reminyl DMF submitted to regulatory agencies in the US is known as a USDMF. Reminyl USDMF includes data on Reminyl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Reminyl USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Reminyl 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 Reminyl Drug Master File in Japan (Reminyl JDMF) empowers Reminyl 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 Reminyl JDMF during the approval evaluation for pharmaceutical products. At the time of Reminyl 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 Reminyl 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 Reminyl Drug Master File in Korea (Reminyl KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Reminyl. The MFDS reviews the Reminyl KDMF as part of the drug registration process and uses the information provided in the Reminyl KDMF to evaluate the safety and efficacy of the drug.
After submitting a Reminyl 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 Reminyl API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Reminyl suppliers with KDMF on PharmaCompass.
A Reminyl CEP of the European Pharmacopoeia monograph is often referred to as a Reminyl Certificate of Suitability (COS). The purpose of a Reminyl CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Reminyl EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Reminyl to their clients by showing that a Reminyl CEP has been issued for it. The manufacturer submits a Reminyl CEP (COS) as part of the market authorization procedure, and it takes on the role of a Reminyl CEP holder for the record. Additionally, the data presented in the Reminyl CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Reminyl DMF.
A Reminyl CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Reminyl 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 Reminyl suppliers with CEP (COS) on PharmaCompass.
A Reminyl written confirmation (Reminyl WC) is an official document issued by a regulatory agency to a Reminyl manufacturer, verifying that the manufacturing facility of a Reminyl active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Reminyl APIs or Reminyl finished pharmaceutical products to another nation, regulatory agencies frequently require a Reminyl WC (written confirmation) as part of the regulatory process.
click here to find a list of Reminyl 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 Reminyl as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Reminyl 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 Reminyl 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 Reminyl and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Reminyl NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Reminyl suppliers with NDC on PharmaCompass.
Reminyl 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 Reminyl 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 Reminyl GMP manufacturer or Reminyl GMP API supplier for your needs.
A Reminyl CoA (Certificate of Analysis) is a formal document that attests to Reminyl's compliance with Reminyl specifications and serves as a tool for batch-level quality control.
Reminyl CoA mostly includes findings from lab analyses of a specific batch. For each Reminyl 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.
Reminyl may be tested according to a variety of international standards, such as European Pharmacopoeia (Reminyl EP), Reminyl JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Reminyl USP).
