Synopsis
0
VMF
DRUG PRODUCT COMPOSITIONS0
FDF
0
Stock Recap #PipelineProspector
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE 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]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
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
Related Excipient Companies
Minakem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Boai NKY Pharmaceuticals Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Minbiotech
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pfanstiehl
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kirsch Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Panvo Organics
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Cerata Pharmaceuticals LLP
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Dr. Paul Lohmann GmbH & Co. KGaA
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ACG Worldwide
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Aeon Procare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Alcedo Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ashland
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Clariant
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Corel Pharma Chem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DFE Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Esteem Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gloria Interchem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ideal Cures
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Keval Exports
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kima Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lonza Capsugel
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Bold Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Neelkanth MineChem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nitika Pharmaceutical Specialities
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nomisma Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Novo Excipients
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharmatrans-Sanaq
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Prachin Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qianhao Chemical (Hebei) Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qualicaps
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seppic
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shijiazhuang Huaxu Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Silverline Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]The Dow Chemical Company
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ulanqab Kema New Material
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Valens Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Fillers, Diluents & Binders
Coating Systems & Additives
Direct Compression
Disintegrants & Superdisintegrants
Granulation
Thickeners and Stabilizers
Controlled & Modified Release
Solubilizers
Taste Masking
Chewable & Orodispersible Aids
Lubricants & Glidants
Film Formers & Plasticizers
Parenteral
Topical
Co-Processed Excipients
Empty Capsules
Emulsifying Agents
Surfactant & Foaming Agents
API Stability Enhancers
Rheology Modifiers
Vegetarian Capsules
Coloring Agents
Digital Content
DATA COMPILATION #PharmaFlow
WEEKLY NEWS RECAP #Phispers
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
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
62
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 Galanthamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Galanthamine, including repackagers and relabelers. The FDA regulates Galanthamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Galanthamine 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 Galanthamine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Galanthamine supplier is an individual or a company that provides Galanthamine active pharmaceutical ingredient (API) or Galanthamine finished formulations upon request. The Galanthamine suppliers may include Galanthamine API manufacturers, exporters, distributors and traders.
click here to find a list of Galanthamine suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Galanthamine DMF (Drug Master File) is a document detailing the whole manufacturing process of Galanthamine active pharmaceutical ingredient (API) in detail. Different forms of Galanthamine DMFs exist exist since differing nations have different regulations, such as Galanthamine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Galanthamine DMF submitted to regulatory agencies in the US is known as a USDMF. Galanthamine USDMF includes data on Galanthamine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Galanthamine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Galanthamine 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 Galanthamine Drug Master File in Japan (Galanthamine JDMF) empowers Galanthamine 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 Galanthamine JDMF during the approval evaluation for pharmaceutical products. At the time of Galanthamine 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 Galanthamine 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 Galanthamine Drug Master File in Korea (Galanthamine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Galanthamine. The MFDS reviews the Galanthamine KDMF as part of the drug registration process and uses the information provided in the Galanthamine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Galanthamine 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 Galanthamine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Galanthamine suppliers with KDMF on PharmaCompass.
A Galanthamine CEP of the European Pharmacopoeia monograph is often referred to as a Galanthamine Certificate of Suitability (COS). The purpose of a Galanthamine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Galanthamine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Galanthamine to their clients by showing that a Galanthamine CEP has been issued for it. The manufacturer submits a Galanthamine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Galanthamine CEP holder for the record. Additionally, the data presented in the Galanthamine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Galanthamine DMF.
A Galanthamine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Galanthamine 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 Galanthamine suppliers with CEP (COS) on PharmaCompass.
A Galanthamine written confirmation (Galanthamine WC) is an official document issued by a regulatory agency to a Galanthamine manufacturer, verifying that the manufacturing facility of a Galanthamine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Galanthamine APIs or Galanthamine finished pharmaceutical products to another nation, regulatory agencies frequently require a Galanthamine WC (written confirmation) as part of the regulatory process.
click here to find a list of Galanthamine 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 Galanthamine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Galanthamine 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 Galanthamine 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 Galanthamine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Galanthamine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Galanthamine suppliers with NDC on PharmaCompass.
Galanthamine 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 Galanthamine GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Galanthamine GMP manufacturer or Galanthamine GMP API supplier for your needs.
A Galanthamine CoA (Certificate of Analysis) is a formal document that attests to Galanthamine's compliance with Galanthamine specifications and serves as a tool for batch-level quality control.
Galanthamine CoA mostly includes findings from lab analyses of a specific batch. For each Galanthamine 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.
Galanthamine may be tested according to a variety of international standards, such as European Pharmacopoeia (Galanthamine EP), Galanthamine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Galanthamine USP).
