Synopsis
0
VMF
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
0
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]KDMF
Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
Registrant Name : Gunil Pharmaceutical Co., Ltd.
Registration Date : 2017-07-27
Registration Number : Number 2816-7-ND(1)
Manufacturer Name : Farmak, as
Manufacturer Address : Na vlcinci 16/3, Klasterni Hradisko, 779 00 Olomouc, Czech Republic
Neuland Laboratories- A dedicated 100% API provider.
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2020-06-30
Registration Number : Su434-12-ND
Manufacturer Name : Neuland Laboratories Limited...
Manufacturer Address : Plot No. 92-94, 257-259 IDA, Pashamylaram, Isnapur Village, Patancheru Mandal, Sangar...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]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 - GRANULE;ORAL - 180MG
USFDA APPLICATION NUMBER - 207968
DOSAGE - GRANULE;ORAL - 360MG
USFDA APPLICATION NUMBER - 207968
DOSAGE - GRANULE;ORAL - 90MG
USFDA APPLICATION NUMBER - 207968
Related Excipient Companies
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]Kirsch Pharma
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]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
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]Gangwal Chemicals
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]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]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]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 Chemical
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]Shanghai Welltone Material Technology Co., Ltd
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]Ulanqab Kema New Material
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Fillers, Diluents & Binders
Granulation
Direct Compression
Lubricants & Glidants
Thickeners and Stabilizers
Co-Processed Excipients
Taste Masking
Emulsifying Agents
Controlled & Modified Release
Coating Systems & Additives
Disintegrants & Superdisintegrants
Solubilizers
Chewable & Orodispersible Aids
Film Formers & Plasticizers
API Stability Enhancers
Surfactant & Foaming Agents
Topical
Parenteral
Rheology Modifiers
Digital Content
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
10
PharmaCompass offers a list of Deferasirox 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 Deferasirox manufacturer or Deferasirox supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Deferasirox manufacturer or Deferasirox supplier.
A Deferasirox manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Deferasirox, including repackagers and relabelers. The FDA regulates Deferasirox manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Deferasirox 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 Deferasirox manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Deferasirox supplier is an individual or a company that provides Deferasirox active pharmaceutical ingredient (API) or Deferasirox finished formulations upon request. The Deferasirox suppliers may include Deferasirox API manufacturers, exporters, distributors and traders.
click here to find a list of Deferasirox suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Deferasirox DMF (Drug Master File) is a document detailing the whole manufacturing process of Deferasirox active pharmaceutical ingredient (API) in detail. Different forms of Deferasirox DMFs exist exist since differing nations have different regulations, such as Deferasirox USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Deferasirox DMF submitted to regulatory agencies in the US is known as a USDMF. Deferasirox USDMF includes data on Deferasirox's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Deferasirox USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Deferasirox 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 Deferasirox Drug Master File in Japan (Deferasirox JDMF) empowers Deferasirox 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 Deferasirox JDMF during the approval evaluation for pharmaceutical products. At the time of Deferasirox 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 Deferasirox 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 Deferasirox Drug Master File in Korea (Deferasirox KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Deferasirox. The MFDS reviews the Deferasirox KDMF as part of the drug registration process and uses the information provided in the Deferasirox KDMF to evaluate the safety and efficacy of the drug.
After submitting a Deferasirox 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 Deferasirox API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Deferasirox suppliers with KDMF on PharmaCompass.
A Deferasirox CEP of the European Pharmacopoeia monograph is often referred to as a Deferasirox Certificate of Suitability (COS). The purpose of a Deferasirox CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Deferasirox EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Deferasirox to their clients by showing that a Deferasirox CEP has been issued for it. The manufacturer submits a Deferasirox CEP (COS) as part of the market authorization procedure, and it takes on the role of a Deferasirox CEP holder for the record. Additionally, the data presented in the Deferasirox CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Deferasirox DMF.
A Deferasirox CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Deferasirox 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 Deferasirox suppliers with CEP (COS) on PharmaCompass.
A Deferasirox written confirmation (Deferasirox WC) is an official document issued by a regulatory agency to a Deferasirox manufacturer, verifying that the manufacturing facility of a Deferasirox active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Deferasirox APIs or Deferasirox finished pharmaceutical products to another nation, regulatory agencies frequently require a Deferasirox WC (written confirmation) as part of the regulatory process.
click here to find a list of Deferasirox 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 Deferasirox as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Deferasirox 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 Deferasirox 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 Deferasirox and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Deferasirox NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Deferasirox suppliers with NDC on PharmaCompass.
Deferasirox 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 Deferasirox GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Deferasirox GMP manufacturer or Deferasirox GMP API supplier for your needs.
A Deferasirox CoA (Certificate of Analysis) is a formal document that attests to Deferasirox's compliance with Deferasirox specifications and serves as a tool for batch-level quality control.
Deferasirox CoA mostly includes findings from lab analyses of a specific batch. For each Deferasirox 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.
Deferasirox may be tested according to a variety of international standards, such as European Pharmacopoeia (Deferasirox EP), Deferasirox JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Deferasirox USP).
