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USDMF
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Indena - Advancing botanical science with a century of innovation, quality, and trusted global expertise.
Galantamine Hydrobromide, Isolated From Natural ...
Certificate Number : R1-CEP 2011-288 - Rev 01
Status : Valid
Issue Date : 2020-11-19
Type : Chemical
Substance Number : 2366
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Lead Product(s) : Galantamine Hydrobromide,Inapplicable
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Galantamine Bioequivalence Study of Dr. Reddy's Under Fasting Condition
Details : Galantamine is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
June 13, 2011
Lead Product(s) : Galantamine Hydrobromide,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Galantamine Bioequivalence Study of Dr. Reddy's Under Fed Condition
Details : Reminyl (Galantamine) is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Feeding and Eating Disorders.
Product Name : Reminyl
Product Type : Miscellaneous
Upfront Cash : Inapplicable
June 13, 2011
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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**Federal...DOSAGE - TABLET;ORAL - EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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**Federal ...DOSAGE - TABLET;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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**Federal ...DOSAGE - TABLET;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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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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, 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.
A Galantamine HBr manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Galantamine HBr, including repackagers and relabelers. The FDA regulates Galantamine HBr manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Galantamine HBr 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 Galantamine HBr manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Galantamine HBr supplier is an individual or a company that provides Galantamine HBr active pharmaceutical ingredient (API) or Galantamine HBr finished formulations upon request. The Galantamine HBr suppliers may include Galantamine HBr API manufacturers, exporters, distributors and traders.
click here to find a list of Galantamine HBr suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Galantamine HBr DMF (Drug Master File) is a document detailing the whole manufacturing process of Galantamine HBr active pharmaceutical ingredient (API) in detail. Different forms of Galantamine HBr DMFs exist exist since differing nations have different regulations, such as Galantamine HBr USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Galantamine HBr DMF submitted to regulatory agencies in the US is known as a USDMF. Galantamine HBr USDMF includes data on Galantamine HBr's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Galantamine HBr USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Galantamine HBr 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 Galantamine HBr Drug Master File in Japan (Galantamine HBr JDMF) empowers Galantamine HBr 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 Galantamine HBr JDMF during the approval evaluation for pharmaceutical products. At the time of Galantamine HBr 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 Galantamine HBr 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 Galantamine HBr Drug Master File in Korea (Galantamine HBr KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Galantamine HBr. The MFDS reviews the Galantamine HBr KDMF as part of the drug registration process and uses the information provided in the Galantamine HBr KDMF to evaluate the safety and efficacy of the drug.
After submitting a Galantamine HBr 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 Galantamine HBr API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Galantamine HBr suppliers with KDMF on PharmaCompass.
A Galantamine HBr CEP of the European Pharmacopoeia monograph is often referred to as a Galantamine HBr Certificate of Suitability (COS). The purpose of a Galantamine HBr CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Galantamine HBr EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Galantamine HBr to their clients by showing that a Galantamine HBr CEP has been issued for it. The manufacturer submits a Galantamine HBr CEP (COS) as part of the market authorization procedure, and it takes on the role of a Galantamine HBr CEP holder for the record. Additionally, the data presented in the Galantamine HBr CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Galantamine HBr DMF.
A Galantamine HBr CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Galantamine HBr 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 Galantamine HBr suppliers with CEP (COS) on PharmaCompass.
A Galantamine HBr written confirmation (Galantamine HBr WC) is an official document issued by a regulatory agency to a Galantamine HBr manufacturer, verifying that the manufacturing facility of a Galantamine HBr active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Galantamine HBr APIs or Galantamine HBr finished pharmaceutical products to another nation, regulatory agencies frequently require a Galantamine HBr WC (written confirmation) as part of the regulatory process.
click here to find a list of Galantamine HBr 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 Galantamine HBr as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Galantamine HBr 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 Galantamine HBr 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 Galantamine HBr and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Galantamine HBr NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Galantamine HBr suppliers with NDC on PharmaCompass.
Galantamine HBr 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 Galantamine HBr GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Galantamine HBr GMP manufacturer or Galantamine HBr GMP API supplier for your needs.
A Galantamine HBr CoA (Certificate of Analysis) is a formal document that attests to Galantamine HBr's compliance with Galantamine HBr specifications and serves as a tool for batch-level quality control.
Galantamine HBr CoA mostly includes findings from lab analyses of a specific batch. For each Galantamine HBr 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.
Galantamine HBr may be tested according to a variety of international standards, such as European Pharmacopoeia (Galantamine HBr EP), Galantamine HBr JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Galantamine HBr USP).
