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API SUPPLIERS
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USDMF
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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**Federal...DOSAGE - TABLET;ORAL - EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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**Federal ...DOSAGE - TABLET;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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**Federal ...DOSAGE - TABLET;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- CAPSULE, EXTENDED RELEASE;ORAL - EQ 16MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- CAPSULE, EXTENDED RELEASE;ORAL - EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- CAPSULE, EXTENDED RELEASE;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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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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 G1660_SIGMA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of G1660_SIGMA, including repackagers and relabelers. The FDA regulates G1660_SIGMA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. G1660_SIGMA 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 G1660_SIGMA manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A G1660_SIGMA supplier is an individual or a company that provides G1660_SIGMA active pharmaceutical ingredient (API) or G1660_SIGMA finished formulations upon request. The G1660_SIGMA suppliers may include G1660_SIGMA API manufacturers, exporters, distributors and traders.
click here to find a list of G1660_SIGMA suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A G1660_SIGMA DMF (Drug Master File) is a document detailing the whole manufacturing process of G1660_SIGMA active pharmaceutical ingredient (API) in detail. Different forms of G1660_SIGMA DMFs exist exist since differing nations have different regulations, such as G1660_SIGMA USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A G1660_SIGMA DMF submitted to regulatory agencies in the US is known as a USDMF. G1660_SIGMA USDMF includes data on G1660_SIGMA's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The G1660_SIGMA USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of G1660_SIGMA 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 G1660_SIGMA Drug Master File in Japan (G1660_SIGMA JDMF) empowers G1660_SIGMA 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 G1660_SIGMA JDMF during the approval evaluation for pharmaceutical products. At the time of G1660_SIGMA 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 G1660_SIGMA 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 G1660_SIGMA Drug Master File in Korea (G1660_SIGMA KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of G1660_SIGMA. The MFDS reviews the G1660_SIGMA KDMF as part of the drug registration process and uses the information provided in the G1660_SIGMA KDMF to evaluate the safety and efficacy of the drug.
After submitting a G1660_SIGMA 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 G1660_SIGMA API can apply through the Korea Drug Master File (KDMF).
click here to find a list of G1660_SIGMA suppliers with KDMF on PharmaCompass.
A G1660_SIGMA CEP of the European Pharmacopoeia monograph is often referred to as a G1660_SIGMA Certificate of Suitability (COS). The purpose of a G1660_SIGMA CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of G1660_SIGMA EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of G1660_SIGMA to their clients by showing that a G1660_SIGMA CEP has been issued for it. The manufacturer submits a G1660_SIGMA CEP (COS) as part of the market authorization procedure, and it takes on the role of a G1660_SIGMA CEP holder for the record. Additionally, the data presented in the G1660_SIGMA CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the G1660_SIGMA DMF.
A G1660_SIGMA CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. G1660_SIGMA 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 G1660_SIGMA suppliers with CEP (COS) on PharmaCompass.
A G1660_SIGMA written confirmation (G1660_SIGMA WC) is an official document issued by a regulatory agency to a G1660_SIGMA manufacturer, verifying that the manufacturing facility of a G1660_SIGMA active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting G1660_SIGMA APIs or G1660_SIGMA finished pharmaceutical products to another nation, regulatory agencies frequently require a G1660_SIGMA WC (written confirmation) as part of the regulatory process.
click here to find a list of G1660_SIGMA 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 G1660_SIGMA as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for G1660_SIGMA 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 G1660_SIGMA 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 G1660_SIGMA and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a G1660_SIGMA NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of G1660_SIGMA suppliers with NDC on PharmaCompass.
G1660_SIGMA 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 G1660_SIGMA 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 G1660_SIGMA GMP manufacturer or G1660_SIGMA GMP API supplier for your needs.
A G1660_SIGMA CoA (Certificate of Analysis) is a formal document that attests to G1660_SIGMA's compliance with G1660_SIGMA specifications and serves as a tool for batch-level quality control.
G1660_SIGMA CoA mostly includes findings from lab analyses of a specific batch. For each G1660_SIGMA 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.
G1660_SIGMA may be tested according to a variety of international standards, such as European Pharmacopoeia (G1660_SIGMA EP), G1660_SIGMA JP (Japanese Pharmacopeia) and the US Pharmacopoeia (G1660_SIGMA USP).
