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South Africa
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API SUPPLIERS
Aarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.
Macsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.
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USDMF
Aarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.
GDUFA
DMF Review : Complete
Rev. Date : 2025-01-03
Pay. Date : 2024-11-21
DMF Number : 39766
Submission : 2024-04-16
Status :
Type : II
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Aarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.
Certificate Number : CEP 2024-124 - Rev 00
Status : Valid
Issue Date : 2024-10-09
Type : Chemical
Substance Number : 2236
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Aarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.
Date of Issue : 2024-05-20
Valid Till : 2027-05-19
Written Confirmation Number : WC-0295
Address of the Firm : D-53, PHASE II, KALYAN SHILL ROAD, DOMBIVLI (E.), DOMBIVLI - 421204, Taluka: Dom...
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EUROAPI
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Dosage Form : Tablet
Grade : Oral
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Dosage Form : Cream / Lotion / Ointment
Grade : Topical, Parenteral
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ABOUT THIS PAGE
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PharmaCompass offers a list of Deferiprone 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 Deferiprone manufacturer or Deferiprone supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Deferiprone manufacturer or Deferiprone supplier.
PharmaCompass also assists you with knowing the Deferiprone API Price utilized in the formulation of products. Deferiprone API Price is not always fixed or binding as the Deferiprone Price is obtained through a variety of data sources. The Deferiprone Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Kelfer manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Kelfer, including repackagers and relabelers. The FDA regulates Kelfer manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Kelfer 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 Kelfer manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Kelfer supplier is an individual or a company that provides Kelfer active pharmaceutical ingredient (API) or Kelfer finished formulations upon request. The Kelfer suppliers may include Kelfer API manufacturers, exporters, distributors and traders.
click here to find a list of Kelfer suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Kelfer DMF (Drug Master File) is a document detailing the whole manufacturing process of Kelfer active pharmaceutical ingredient (API) in detail. Different forms of Kelfer DMFs exist exist since differing nations have different regulations, such as Kelfer USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Kelfer DMF submitted to regulatory agencies in the US is known as a USDMF. Kelfer USDMF includes data on Kelfer's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Kelfer USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Kelfer suppliers with USDMF 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 Kelfer Drug Master File in Korea (Kelfer KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Kelfer. The MFDS reviews the Kelfer KDMF as part of the drug registration process and uses the information provided in the Kelfer KDMF to evaluate the safety and efficacy of the drug.
After submitting a Kelfer 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 Kelfer API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Kelfer suppliers with KDMF on PharmaCompass.
A Kelfer CEP of the European Pharmacopoeia monograph is often referred to as a Kelfer Certificate of Suitability (COS). The purpose of a Kelfer CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Kelfer EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Kelfer to their clients by showing that a Kelfer CEP has been issued for it. The manufacturer submits a Kelfer CEP (COS) as part of the market authorization procedure, and it takes on the role of a Kelfer CEP holder for the record. Additionally, the data presented in the Kelfer CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Kelfer DMF.
A Kelfer CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Kelfer 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 Kelfer suppliers with CEP (COS) on PharmaCompass.
A Kelfer written confirmation (Kelfer WC) is an official document issued by a regulatory agency to a Kelfer manufacturer, verifying that the manufacturing facility of a Kelfer active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Kelfer APIs or Kelfer finished pharmaceutical products to another nation, regulatory agencies frequently require a Kelfer WC (written confirmation) as part of the regulatory process.
click here to find a list of Kelfer 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 Kelfer as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Kelfer 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 Kelfer 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 Kelfer and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Kelfer NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Kelfer suppliers with NDC on PharmaCompass.
Kelfer 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 Kelfer 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 Kelfer GMP manufacturer or Kelfer GMP API supplier for your needs.
A Kelfer CoA (Certificate of Analysis) is a formal document that attests to Kelfer's compliance with Kelfer specifications and serves as a tool for batch-level quality control.
Kelfer CoA mostly includes findings from lab analyses of a specific batch. For each Kelfer 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.
Kelfer may be tested according to a variety of international standards, such as European Pharmacopoeia (Kelfer EP), Kelfer JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Kelfer USP).
