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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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EDQM
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USP
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JP
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Canada
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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
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Siegfried – A global CDMO delivering integrated pharmaceutical development and manufacturing solutions.
About the Company : Siegfried is a global Contract Development and Manufacturing Organization providing integrated services for pharmaceutical ingredients & finished dosage forms. With 13 production s...
Veranova: A CDMO that manages complexity with confidence.
About the Company : Veranova is a global leader in developing and manufacturing specialist and complex APIs for pharma and biotech customers, with over 50 years of experience supporting the healthcare...
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Dexmethylphenidate Hydrochloride
About the Company : Cohance Lifesciences is a leading CDMO and API platform delivering products and services across the full molecule lifecycle, from development to commercialization. With strong expe...
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
Dexmethylphenidate Hydrochloride
About the Company : Noramco, founded in 1979, specializes in developing and manufacturing APIs for opioid and non-opioid products. It excels in controlled substance development, offering supply-chain ...
Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
Dexmethylphenidate Hydrochloride
About the Company : Curia is a leading global CDMO with over 30 years of experience supporting clients across drug discovery, development, and commercial manufacturing. Leveraging deep scientific expe...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
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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
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PharmaCompass offers a list of Dexmethylphenidate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Dexmethylphenidate manufacturer or Dexmethylphenidate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dexmethylphenidate manufacturer or Dexmethylphenidate supplier.
A Focalin XR manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Focalin XR, including repackagers and relabelers. The FDA regulates Focalin XR manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Focalin XR 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 Focalin XR manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Focalin XR supplier is an individual or a company that provides Focalin XR active pharmaceutical ingredient (API) or Focalin XR finished formulations upon request. The Focalin XR suppliers may include Focalin XR API manufacturers, exporters, distributors and traders.
click here to find a list of Focalin XR suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Focalin XR DMF (Drug Master File) is a document detailing the whole manufacturing process of Focalin XR active pharmaceutical ingredient (API) in detail. Different forms of Focalin XR DMFs exist exist since differing nations have different regulations, such as Focalin XR USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Focalin XR DMF submitted to regulatory agencies in the US is known as a USDMF. Focalin XR USDMF includes data on Focalin XR's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Focalin XR USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Focalin XR 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 Focalin XR as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Focalin XR 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 Focalin XR 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 Focalin XR and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Focalin XR NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Focalin XR suppliers with NDC on PharmaCompass.
Focalin XR 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 Focalin XR GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Focalin XR GMP manufacturer or Focalin XR GMP API supplier for your needs.
A Focalin XR CoA (Certificate of Analysis) is a formal document that attests to Focalin XR's compliance with Focalin XR specifications and serves as a tool for batch-level quality control.
Focalin XR CoA mostly includes findings from lab analyses of a specific batch. For each Focalin XR 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.
Focalin XR may be tested according to a variety of international standards, such as European Pharmacopoeia (Focalin XR EP), Focalin XR JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Focalin XR USP).
