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CEP/COS
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JDMF
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KDMF
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VMF
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EDQM
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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
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DOSAGE - CAPSULE;ORAL - 10MG
USFDA APPLICATION NUMBER - 21977
DOSAGE - CAPSULE;ORAL - 20MG
USFDA APPLICATION NUMBER - 21977
DOSAGE - CAPSULE;ORAL - 30MG
USFDA APPLICATION NUMBER - 21977
DOSAGE - CAPSULE;ORAL - 40MG
USFDA APPLICATION NUMBER - 21977
DOSAGE - CAPSULE;ORAL - 50MG
USFDA APPLICATION NUMBER - 21977
DOSAGE - CAPSULE;ORAL - 60MG
USFDA APPLICATION NUMBER - 21977
DOSAGE - CAPSULE;ORAL - 70MG
USFDA APPLICATION NUMBER - 21977
Related Excipient Companies
Rochem International Inc
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ABOUT THIS PAGE
17
PharmaCompass offers a list of Lisdexamfetamine Dimesylate 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 Lisdexamfetamine Dimesylate manufacturer or Lisdexamfetamine Dimesylate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Lisdexamfetamine Dimesylate manufacturer or Lisdexamfetamine Dimesylate supplier.
PharmaCompass also assists you with knowing the Lisdexamfetamine Dimesylate API Price utilized in the formulation of products. Lisdexamfetamine Dimesylate API Price is not always fixed or binding as the Lisdexamfetamine Dimesylate Price is obtained through a variety of data sources. The Lisdexamfetamine Dimesylate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A LDX manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of LDX, including repackagers and relabelers. The FDA regulates LDX manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. LDX 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 LDX manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A LDX supplier is an individual or a company that provides LDX active pharmaceutical ingredient (API) or LDX finished formulations upon request. The LDX suppliers may include LDX API manufacturers, exporters, distributors and traders.
click here to find a list of LDX suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A LDX DMF (Drug Master File) is a document detailing the whole manufacturing process of LDX active pharmaceutical ingredient (API) in detail. Different forms of LDX DMFs exist exist since differing nations have different regulations, such as LDX USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A LDX DMF submitted to regulatory agencies in the US is known as a USDMF. LDX USDMF includes data on LDX's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The LDX USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of LDX suppliers with USDMF on PharmaCompass.
A LDX written confirmation (LDX WC) is an official document issued by a regulatory agency to a LDX manufacturer, verifying that the manufacturing facility of a LDX active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting LDX APIs or LDX finished pharmaceutical products to another nation, regulatory agencies frequently require a LDX WC (written confirmation) as part of the regulatory process.
click here to find a list of LDX 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 LDX as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for LDX 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 LDX 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 LDX and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a LDX NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of LDX suppliers with NDC on PharmaCompass.
LDX 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 LDX 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 LDX GMP manufacturer or LDX GMP API supplier for your needs.
A LDX CoA (Certificate of Analysis) is a formal document that attests to LDX's compliance with LDX specifications and serves as a tool for batch-level quality control.
LDX CoA mostly includes findings from lab analyses of a specific batch. For each LDX 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.
LDX may be tested according to a variety of international standards, such as European Pharmacopoeia (LDX EP), LDX JP (Japanese Pharmacopeia) and the US Pharmacopoeia (LDX USP).
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