Synopsis
0
VMF
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
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
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]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
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 - INJECTABLE;INJECTION - EQ 1GM BASE/V...DOSAGE - INJECTABLE;INJECTION - EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20509
DOSAGE - INJECTABLE;INJECTION - EQ 200MG BASE...DOSAGE - INJECTABLE;INJECTION - EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20509
DOSAGE - SOLUTION;INTRAVENOUS - EQ 1200MG BAS...DOSAGE - SOLUTION;INTRAVENOUS - EQ 1200MG BASE/120ML (EQ 10MG BASE/ML)
USFDA APPLICATION NUMBER - 208313
DOSAGE - SOLUTION;INTRAVENOUS - EQ 1300MG BAS...DOSAGE - SOLUTION;INTRAVENOUS - EQ 1300MG BASE/130ML (EQ 10MG BASE/ML)
USFDA APPLICATION NUMBER - 208313
DOSAGE - SOLUTION;INTRAVENOUS - EQ 1400MG BAS...DOSAGE - SOLUTION;INTRAVENOUS - EQ 1400MG BASE/140ML (EQ 10MG BASE/ML)
USFDA APPLICATION NUMBER - 208313
DOSAGE - SOLUTION;INTRAVENOUS - EQ 1500MG BAS...DOSAGE - SOLUTION;INTRAVENOUS - EQ 1500MG BASE/150ML (EQ 10MG BASE/ML)
USFDA APPLICATION NUMBER - 208313
DOSAGE - SOLUTION;INTRAVENOUS - EQ 1600MG BAS...DOSAGE - SOLUTION;INTRAVENOUS - EQ 1600MG BASE/160ML (EQ 10MG BASE/ML)
USFDA APPLICATION NUMBER - 208313
DOSAGE - SOLUTION;INTRAVENOUS - EQ 1700MG BAS...DOSAGE - SOLUTION;INTRAVENOUS - EQ 1700MG BASE/170ML (EQ 10MG BASE/ML)
USFDA APPLICATION NUMBER - 208313
DOSAGE - SOLUTION;INTRAVENOUS - EQ 1800MG BAS...DOSAGE - SOLUTION;INTRAVENOUS - EQ 1800MG BASE/180ML (EQ 10MG BASE/ML)
USFDA APPLICATION NUMBER - 208313
DOSAGE - SOLUTION;INTRAVENOUS - EQ 1900MG BAS...DOSAGE - SOLUTION;INTRAVENOUS - EQ 1900MG BASE/190ML (EQ 10MG BASE/ML)
USFDA APPLICATION NUMBER - 208313
DOSAGE - SOLUTION;INTRAVENOUS - EQ 2000MG BAS...DOSAGE - SOLUTION;INTRAVENOUS - EQ 2000MG BASE/200ML (EQ 10MG BASE/ML)
USFDA APPLICATION NUMBER - 208313
DOSAGE - SOLUTION;INTRAVENOUS - EQ 2200MG BAS...DOSAGE - SOLUTION;INTRAVENOUS - EQ 2200MG BASE/220ML (EQ 10MG BASE/ML)
USFDA APPLICATION NUMBER - 208313
Related Excipient Companies
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]Faran Shimi Pharmaceutical
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]Pfanstiehl
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]Gangwal Chemicals
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]Microlex e.U
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]Roquette
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]Fillers, Diluents & Binders
Chewable & Orodispersible Aids
Taste Masking
Direct Compression
Disintegrants & Superdisintegrants
Co-Processed Excipients
Parenteral
Granulation
Solubilizers
Thickeners and Stabilizers
Digital Content
DATA COMPILATION #PharmaFlow
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
91
PharmaCompass offers a list of Gemcitabine 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 Gemcitabine manufacturer or Gemcitabine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Gemcitabine manufacturer or Gemcitabine supplier.
PharmaCompass also assists you with knowing the Gemcitabine API Price utilized in the formulation of products. Gemcitabine API Price is not always fixed or binding as the Gemcitabine Price is obtained through a variety of data sources. The Gemcitabine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Gemsar manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gemsar, including repackagers and relabelers. The FDA regulates Gemsar manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gemsar 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 Gemsar manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gemsar supplier is an individual or a company that provides Gemsar active pharmaceutical ingredient (API) or Gemsar finished formulations upon request. The Gemsar suppliers may include Gemsar API manufacturers, exporters, distributors and traders.
click here to find a list of Gemsar suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gemsar DMF (Drug Master File) is a document detailing the whole manufacturing process of Gemsar active pharmaceutical ingredient (API) in detail. Different forms of Gemsar DMFs exist exist since differing nations have different regulations, such as Gemsar USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gemsar DMF submitted to regulatory agencies in the US is known as a USDMF. Gemsar USDMF includes data on Gemsar's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gemsar USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gemsar 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 Gemsar Drug Master File in Japan (Gemsar JDMF) empowers Gemsar 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 Gemsar JDMF during the approval evaluation for pharmaceutical products. At the time of Gemsar 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 Gemsar 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 Gemsar Drug Master File in Korea (Gemsar KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Gemsar. The MFDS reviews the Gemsar KDMF as part of the drug registration process and uses the information provided in the Gemsar KDMF to evaluate the safety and efficacy of the drug.
After submitting a Gemsar 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 Gemsar API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Gemsar suppliers with KDMF on PharmaCompass.
A Gemsar CEP of the European Pharmacopoeia monograph is often referred to as a Gemsar Certificate of Suitability (COS). The purpose of a Gemsar CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Gemsar EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Gemsar to their clients by showing that a Gemsar CEP has been issued for it. The manufacturer submits a Gemsar CEP (COS) as part of the market authorization procedure, and it takes on the role of a Gemsar CEP holder for the record. Additionally, the data presented in the Gemsar CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Gemsar DMF.
A Gemsar CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Gemsar 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 Gemsar suppliers with CEP (COS) on PharmaCompass.
A Gemsar written confirmation (Gemsar WC) is an official document issued by a regulatory agency to a Gemsar manufacturer, verifying that the manufacturing facility of a Gemsar active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Gemsar APIs or Gemsar finished pharmaceutical products to another nation, regulatory agencies frequently require a Gemsar WC (written confirmation) as part of the regulatory process.
click here to find a list of Gemsar 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 Gemsar as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Gemsar 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 Gemsar 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 Gemsar and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Gemsar NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Gemsar suppliers with NDC on PharmaCompass.
Gemsar 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 Gemsar 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 Gemsar GMP manufacturer or Gemsar GMP API supplier for your needs.
A Gemsar CoA (Certificate of Analysis) is a formal document that attests to Gemsar's compliance with Gemsar specifications and serves as a tool for batch-level quality control.
Gemsar CoA mostly includes findings from lab analyses of a specific batch. For each Gemsar 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.
Gemsar may be tested according to a variety of international standards, such as European Pharmacopoeia (Gemsar EP), Gemsar JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Gemsar USP).
