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API SUPPLIERS
Capital Farma, a leading European pharmaceutical company focusing on the development & distribution of niche APIs & Pharma Services.
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
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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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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**Federal...DOSAGE - TABLET;ORAL - EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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**Federal ...DOSAGE - TABLET;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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**Federal ...DOSAGE - TABLET;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- CAPSULE, EXTENDED RELEASE;ORAL - EQ 16MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- CAPSULE, EXTENDED RELEASE;ORAL - EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- CAPSULE, EXTENDED RELEASE;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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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28
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 Galanthamine hydrobromide from Lycoris sp. manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Galanthamine hydrobromide from Lycoris sp., including repackagers and relabelers. The FDA regulates Galanthamine hydrobromide from Lycoris sp. manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Galanthamine hydrobromide from Lycoris sp. 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 hydrobromide from Lycoris sp. manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Galanthamine hydrobromide from Lycoris sp. supplier is an individual or a company that provides Galanthamine hydrobromide from Lycoris sp. active pharmaceutical ingredient (API) or Galanthamine hydrobromide from Lycoris sp. finished formulations upon request. The Galanthamine hydrobromide from Lycoris sp. suppliers may include Galanthamine hydrobromide from Lycoris sp. API manufacturers, exporters, distributors and traders.
click here to find a list of Galanthamine hydrobromide from Lycoris sp. suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Galanthamine hydrobromide from Lycoris sp. DMF (Drug Master File) is a document detailing the whole manufacturing process of Galanthamine hydrobromide from Lycoris sp. active pharmaceutical ingredient (API) in detail. Different forms of Galanthamine hydrobromide from Lycoris sp. DMFs exist exist since differing nations have different regulations, such as Galanthamine hydrobromide from Lycoris sp. USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Galanthamine hydrobromide from Lycoris sp. DMF submitted to regulatory agencies in the US is known as a USDMF. Galanthamine hydrobromide from Lycoris sp. USDMF includes data on Galanthamine hydrobromide from Lycoris sp.'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Galanthamine hydrobromide from Lycoris sp. USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Galanthamine hydrobromide from Lycoris sp. 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 hydrobromide from Lycoris sp. Drug Master File in Japan (Galanthamine hydrobromide from Lycoris sp. JDMF) empowers Galanthamine hydrobromide from Lycoris sp. 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 hydrobromide from Lycoris sp. JDMF during the approval evaluation for pharmaceutical products. At the time of Galanthamine hydrobromide from Lycoris sp. 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 hydrobromide from Lycoris sp. 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 hydrobromide from Lycoris sp. Drug Master File in Korea (Galanthamine hydrobromide from Lycoris sp. KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Galanthamine hydrobromide from Lycoris sp.. The MFDS reviews the Galanthamine hydrobromide from Lycoris sp. KDMF as part of the drug registration process and uses the information provided in the Galanthamine hydrobromide from Lycoris sp. KDMF to evaluate the safety and efficacy of the drug.
After submitting a Galanthamine hydrobromide from Lycoris sp. 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 hydrobromide from Lycoris sp. API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Galanthamine hydrobromide from Lycoris sp. suppliers with KDMF on PharmaCompass.
A Galanthamine hydrobromide from Lycoris sp. CEP of the European Pharmacopoeia monograph is often referred to as a Galanthamine hydrobromide from Lycoris sp. Certificate of Suitability (COS). The purpose of a Galanthamine hydrobromide from Lycoris sp. CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Galanthamine hydrobromide from Lycoris sp. EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Galanthamine hydrobromide from Lycoris sp. to their clients by showing that a Galanthamine hydrobromide from Lycoris sp. CEP has been issued for it. The manufacturer submits a Galanthamine hydrobromide from Lycoris sp. CEP (COS) as part of the market authorization procedure, and it takes on the role of a Galanthamine hydrobromide from Lycoris sp. CEP holder for the record. Additionally, the data presented in the Galanthamine hydrobromide from Lycoris sp. CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Galanthamine hydrobromide from Lycoris sp. DMF.
A Galanthamine hydrobromide from Lycoris sp. CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Galanthamine hydrobromide from Lycoris sp. 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 hydrobromide from Lycoris sp. suppliers with CEP (COS) on PharmaCompass.
A Galanthamine hydrobromide from Lycoris sp. written confirmation (Galanthamine hydrobromide from Lycoris sp. WC) is an official document issued by a regulatory agency to a Galanthamine hydrobromide from Lycoris sp. manufacturer, verifying that the manufacturing facility of a Galanthamine hydrobromide from Lycoris sp. active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Galanthamine hydrobromide from Lycoris sp. APIs or Galanthamine hydrobromide from Lycoris sp. finished pharmaceutical products to another nation, regulatory agencies frequently require a Galanthamine hydrobromide from Lycoris sp. WC (written confirmation) as part of the regulatory process.
click here to find a list of Galanthamine hydrobromide from Lycoris sp. 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 hydrobromide from Lycoris sp. as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Galanthamine hydrobromide from Lycoris sp. 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 hydrobromide from Lycoris sp. 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 hydrobromide from Lycoris sp. and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Galanthamine hydrobromide from Lycoris sp. NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Galanthamine hydrobromide from Lycoris sp. suppliers with NDC on PharmaCompass.
Galanthamine hydrobromide from Lycoris sp. 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 hydrobromide from Lycoris sp. 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 Galanthamine hydrobromide from Lycoris sp. GMP manufacturer or Galanthamine hydrobromide from Lycoris sp. GMP API supplier for your needs.
A Galanthamine hydrobromide from Lycoris sp. CoA (Certificate of Analysis) is a formal document that attests to Galanthamine hydrobromide from Lycoris sp.'s compliance with Galanthamine hydrobromide from Lycoris sp. specifications and serves as a tool for batch-level quality control.
Galanthamine hydrobromide from Lycoris sp. CoA mostly includes findings from lab analyses of a specific batch. For each Galanthamine hydrobromide from Lycoris sp. 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 hydrobromide from Lycoris sp. may be tested according to a variety of international standards, such as European Pharmacopoeia (Galanthamine hydrobromide from Lycoris sp. EP), Galanthamine hydrobromide from Lycoris sp. JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Galanthamine hydrobromide from Lycoris sp. USP).
