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DOSAGE - INJECTABLE;INJECTION - EQ 50MG BASE/...DOSAGE - INJECTABLE;INJECTION - EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20207
DOSAGE - POWDER;INTRAVENOUS - EQ 50MG BASE/VI...DOSAGE - POWDER;INTRAVENOUS - EQ 50MG BASE/VIAL
USFDA APPLICATION NUMBER - 207155
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ABOUT THIS PAGE
A Melphalan Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Melphalan Hydrochloride, including repackagers and relabelers. The FDA regulates Melphalan Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Melphalan Hydrochloride 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 Melphalan Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Melphalan Hydrochloride supplier is an individual or a company that provides Melphalan Hydrochloride active pharmaceutical ingredient (API) or Melphalan Hydrochloride finished formulations upon request. The Melphalan Hydrochloride suppliers may include Melphalan Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Melphalan Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Melphalan Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Melphalan Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Melphalan Hydrochloride DMFs exist exist since differing nations have different regulations, such as Melphalan Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Melphalan Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Melphalan Hydrochloride USDMF includes data on Melphalan Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Melphalan Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Melphalan Hydrochloride 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 Melphalan Hydrochloride Drug Master File in Korea (Melphalan Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Melphalan Hydrochloride. The MFDS reviews the Melphalan Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Melphalan Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Melphalan Hydrochloride 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 Melphalan Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Melphalan Hydrochloride suppliers with KDMF on PharmaCompass.
A Melphalan Hydrochloride written confirmation (Melphalan Hydrochloride WC) is an official document issued by a regulatory agency to a Melphalan Hydrochloride manufacturer, verifying that the manufacturing facility of a Melphalan Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Melphalan Hydrochloride APIs or Melphalan Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Melphalan Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Melphalan Hydrochloride 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 Melphalan Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Melphalan Hydrochloride 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 Melphalan Hydrochloride 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 Melphalan Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Melphalan Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Melphalan Hydrochloride suppliers with NDC on PharmaCompass.
Melphalan Hydrochloride 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 Melphalan Hydrochloride 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 Melphalan Hydrochloride GMP manufacturer or Melphalan Hydrochloride GMP API supplier for your needs.
A Melphalan Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Melphalan Hydrochloride's compliance with Melphalan Hydrochloride specifications and serves as a tool for batch-level quality control.
Melphalan Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Melphalan Hydrochloride 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.
Melphalan Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Melphalan Hydrochloride EP), Melphalan Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Melphalan Hydrochloride USP).
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