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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
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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...
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DOSAGE - GRANULE;ORAL - 180MG
USFDA APPLICATION NUMBER - 207968
DOSAGE - GRANULE;ORAL - 360MG
USFDA APPLICATION NUMBER - 207968
DOSAGE - GRANULE;ORAL - 90MG
USFDA APPLICATION NUMBER - 207968
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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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 JADENU manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of JADENU, including repackagers and relabelers. The FDA regulates JADENU manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. JADENU 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 JADENU manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A JADENU supplier is an individual or a company that provides JADENU active pharmaceutical ingredient (API) or JADENU finished formulations upon request. The JADENU suppliers may include JADENU API manufacturers, exporters, distributors and traders.
click here to find a list of JADENU suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A JADENU DMF (Drug Master File) is a document detailing the whole manufacturing process of JADENU active pharmaceutical ingredient (API) in detail. Different forms of JADENU DMFs exist exist since differing nations have different regulations, such as JADENU USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A JADENU DMF submitted to regulatory agencies in the US is known as a USDMF. JADENU USDMF includes data on JADENU's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The JADENU USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of JADENU 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 JADENU Drug Master File in Japan (JADENU JDMF) empowers JADENU 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 JADENU JDMF during the approval evaluation for pharmaceutical products. At the time of JADENU 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 JADENU 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 JADENU Drug Master File in Korea (JADENU KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of JADENU. The MFDS reviews the JADENU KDMF as part of the drug registration process and uses the information provided in the JADENU KDMF to evaluate the safety and efficacy of the drug.
After submitting a JADENU 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 JADENU API can apply through the Korea Drug Master File (KDMF).
click here to find a list of JADENU suppliers with KDMF on PharmaCompass.
A JADENU CEP of the European Pharmacopoeia monograph is often referred to as a JADENU Certificate of Suitability (COS). The purpose of a JADENU CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of JADENU EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of JADENU to their clients by showing that a JADENU CEP has been issued for it. The manufacturer submits a JADENU CEP (COS) as part of the market authorization procedure, and it takes on the role of a JADENU CEP holder for the record. Additionally, the data presented in the JADENU CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the JADENU DMF.
A JADENU CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. JADENU 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 JADENU suppliers with CEP (COS) on PharmaCompass.
A JADENU written confirmation (JADENU WC) is an official document issued by a regulatory agency to a JADENU manufacturer, verifying that the manufacturing facility of a JADENU active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting JADENU APIs or JADENU finished pharmaceutical products to another nation, regulatory agencies frequently require a JADENU WC (written confirmation) as part of the regulatory process.
click here to find a list of JADENU 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 JADENU as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for JADENU 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 JADENU 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 JADENU and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a JADENU NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of JADENU suppliers with NDC on PharmaCompass.
JADENU 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 JADENU GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right JADENU GMP manufacturer or JADENU GMP API supplier for your needs.
A JADENU CoA (Certificate of Analysis) is a formal document that attests to JADENU's compliance with JADENU specifications and serves as a tool for batch-level quality control.
JADENU CoA mostly includes findings from lab analyses of a specific batch. For each JADENU 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.
JADENU may be tested according to a variety of international standards, such as European Pharmacopoeia (JADENU EP), JADENU JP (Japanese Pharmacopeia) and the US Pharmacopoeia (JADENU USP).
