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- INJECTABLE;INJECTION - EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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