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API SUPPLIERS
Veranova: A CDMO that manages complexity with confidence.
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Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
NDC
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Veranova: A CDMO that manages complexity with confidence.
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USDMF
Veranova: A CDMO that manages complexity with confidence.
GDUFA
DMF Review : Complete
Rev. Date : 2023-11-21
Pay. Date : 2023-10-12
DMF Number : 38874
Submission : 2023-10-20
Status :
Type : II
Veranova: A CDMO that manages complexity with confidence.
GDUFA
DMF Review : Complete
Rev. Date : 2020-01-28
Pay. Date : 2020-01-21
DMF Number : 22442
Submission : 2009-01-27
Status :
Type : II
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
GDUFA
DMF Review : Complete
Rev. Date : 2021-12-30
Pay. Date : 2021-11-18
DMF Number : 35645
Submission : 2021-11-23
Status :
Type : II
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DOSAGE - CAPSULE;ORAL - 10MG
USFDA APPLICATION NUMBER - 21977
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USFDA APPLICATION NUMBER - 21977
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USFDA APPLICATION NUMBER - 21977
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USFDA APPLICATION NUMBER - 21977
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USFDA APPLICATION NUMBER - 21977
DOSAGE - CAPSULE;ORAL - 60MG
USFDA APPLICATION NUMBER - 21977
DOSAGE - CAPSULE;ORAL - 70MG
USFDA APPLICATION NUMBER - 21977
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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 L-Lysine-d-amphetamine dimesylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of L-Lysine-d-amphetamine dimesylate, including repackagers and relabelers. The FDA regulates L-Lysine-d-amphetamine dimesylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. L-Lysine-d-amphetamine dimesylate 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 L-Lysine-d-amphetamine dimesylate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A L-Lysine-d-amphetamine dimesylate supplier is an individual or a company that provides L-Lysine-d-amphetamine dimesylate active pharmaceutical ingredient (API) or L-Lysine-d-amphetamine dimesylate finished formulations upon request. The L-Lysine-d-amphetamine dimesylate suppliers may include L-Lysine-d-amphetamine dimesylate API manufacturers, exporters, distributors and traders.
click here to find a list of L-Lysine-d-amphetamine dimesylate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A L-Lysine-d-amphetamine dimesylate DMF (Drug Master File) is a document detailing the whole manufacturing process of L-Lysine-d-amphetamine dimesylate active pharmaceutical ingredient (API) in detail. Different forms of L-Lysine-d-amphetamine dimesylate DMFs exist exist since differing nations have different regulations, such as L-Lysine-d-amphetamine dimesylate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A L-Lysine-d-amphetamine dimesylate DMF submitted to regulatory agencies in the US is known as a USDMF. L-Lysine-d-amphetamine dimesylate USDMF includes data on L-Lysine-d-amphetamine dimesylate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The L-Lysine-d-amphetamine dimesylate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of L-Lysine-d-amphetamine dimesylate suppliers with USDMF on PharmaCompass.
A L-Lysine-d-amphetamine dimesylate written confirmation (L-Lysine-d-amphetamine dimesylate WC) is an official document issued by a regulatory agency to a L-Lysine-d-amphetamine dimesylate manufacturer, verifying that the manufacturing facility of a L-Lysine-d-amphetamine dimesylate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting L-Lysine-d-amphetamine dimesylate APIs or L-Lysine-d-amphetamine dimesylate finished pharmaceutical products to another nation, regulatory agencies frequently require a L-Lysine-d-amphetamine dimesylate WC (written confirmation) as part of the regulatory process.
click here to find a list of L-Lysine-d-amphetamine dimesylate 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 L-Lysine-d-amphetamine dimesylate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for L-Lysine-d-amphetamine dimesylate 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 L-Lysine-d-amphetamine dimesylate 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 L-Lysine-d-amphetamine dimesylate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a L-Lysine-d-amphetamine dimesylate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of L-Lysine-d-amphetamine dimesylate suppliers with NDC on PharmaCompass.
L-Lysine-d-amphetamine dimesylate 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 L-Lysine-d-amphetamine dimesylate 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 L-Lysine-d-amphetamine dimesylate GMP manufacturer or L-Lysine-d-amphetamine dimesylate GMP API supplier for your needs.
A L-Lysine-d-amphetamine dimesylate CoA (Certificate of Analysis) is a formal document that attests to L-Lysine-d-amphetamine dimesylate's compliance with L-Lysine-d-amphetamine dimesylate specifications and serves as a tool for batch-level quality control.
L-Lysine-d-amphetamine dimesylate CoA mostly includes findings from lab analyses of a specific batch. For each L-Lysine-d-amphetamine dimesylate 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.
L-Lysine-d-amphetamine dimesylate may be tested according to a variety of international standards, such as European Pharmacopoeia (L-Lysine-d-amphetamine dimesylate EP), L-Lysine-d-amphetamine dimesylate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (L-Lysine-d-amphetamine dimesylate USP).
