Synopsis
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CEP/COS
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JDMF
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EU WC
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KDMF
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VMF
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FDF
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Canada
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Australia
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South Africa
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Listed Dossiers
DRUG PRODUCT COMPOSITIONS0
EDQM
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USP
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JP
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API SUPPLIERS
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USDMF
Veranova: A CDMO that manages complexity with confidence.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15059
Submission : 2000-09-22
Status :
Type : II
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Veranova: A CDMO that manages complexity with confidence.
About the Company : Veranova is a global leader in the development and manufacturing of specialist and complex APIs for pharma and biotech customers. We have over 50 years of experience navigating the...
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
About the Company : Cohance Lifesciences is a leading CDMO and API platform, offering products and services across all phases of a molecule’s lifecycle from development to commercialzation. With our...
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
Dexmethylphenidate Hydrochloride
About the Company : Founded in 1979, Noramco specializes in the development and manufacturing of APIs for both opioid and non-opioid products. With expertise in controlled substance development and ma...
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DOSAGE - TABLET;ORAL - 10MG
USFDA APPLICATION NUMBER - 21278
DOSAGE - TABLET;ORAL - 2.5MG
USFDA APPLICATION NUMBER - 21278
DOSAGE - TABLET;ORAL - 5MG
USFDA APPLICATION NUMBER - 21278
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 10M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 10MG
USFDA APPLICATION NUMBER - 21802
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 15M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 15MG
USFDA APPLICATION NUMBER - 21802
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 20M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 20MG
USFDA APPLICATION NUMBER - 21802
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 25M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 25MG
USFDA APPLICATION NUMBER - 21802
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 30M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 30MG
USFDA APPLICATION NUMBER - 21802
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 35M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 35MG
USFDA APPLICATION NUMBER - 21802
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 40M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 40MG
USFDA APPLICATION NUMBER - 21802
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 5MG
USFDA APPLICATION NUMBER - 21802
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ABOUT THIS PAGE
A Dexmethylphenidate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dexmethylphenidate, including repackagers and relabelers. The FDA regulates Dexmethylphenidate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dexmethylphenidate 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 Dexmethylphenidate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dexmethylphenidate supplier is an individual or a company that provides Dexmethylphenidate active pharmaceutical ingredient (API) or Dexmethylphenidate finished formulations upon request. The Dexmethylphenidate suppliers may include Dexmethylphenidate API manufacturers, exporters, distributors and traders.
click here to find a list of Dexmethylphenidate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dexmethylphenidate DMF (Drug Master File) is a document detailing the whole manufacturing process of Dexmethylphenidate active pharmaceutical ingredient (API) in detail. Different forms of Dexmethylphenidate DMFs exist exist since differing nations have different regulations, such as Dexmethylphenidate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dexmethylphenidate DMF submitted to regulatory agencies in the US is known as a USDMF. Dexmethylphenidate USDMF includes data on Dexmethylphenidate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dexmethylphenidate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dexmethylphenidate suppliers with USDMF 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 Dexmethylphenidate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dexmethylphenidate 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 Dexmethylphenidate 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 Dexmethylphenidate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dexmethylphenidate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dexmethylphenidate suppliers with NDC on PharmaCompass.
Dexmethylphenidate 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 Dexmethylphenidate 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 Dexmethylphenidate GMP manufacturer or Dexmethylphenidate GMP API supplier for your needs.
A Dexmethylphenidate CoA (Certificate of Analysis) is a formal document that attests to Dexmethylphenidate's compliance with Dexmethylphenidate specifications and serves as a tool for batch-level quality control.
Dexmethylphenidate CoA mostly includes findings from lab analyses of a specific batch. For each Dexmethylphenidate 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.
Dexmethylphenidate may be tested according to a variety of international standards, such as European Pharmacopoeia (Dexmethylphenidate EP), Dexmethylphenidate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dexmethylphenidate USP).
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