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PharmaCompass offers a list of Methylphenidate 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 Methylphenidate Hydrochloride manufacturer or Methylphenidate Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Methylphenidate Hydrochloride manufacturer or Methylphenidate Hydrochloride supplier.
PharmaCompass also assists you with knowing the Methylphenidate Hydrochloride API Price utilized in the formulation of products. Methylphenidate Hydrochloride API Price is not always fixed or binding as the Methylphenidate Hydrochloride Price is obtained through a variety of data sources. The Methylphenidate Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Quillivant XR manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Quillivant XR, including repackagers and relabelers. The FDA regulates Quillivant XR manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Quillivant 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 Quillivant XR manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Quillivant XR supplier is an individual or a company that provides Quillivant XR active pharmaceutical ingredient (API) or Quillivant XR finished formulations upon request. The Quillivant XR suppliers may include Quillivant XR API manufacturers, exporters, distributors and traders.
click here to find a list of Quillivant XR suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Quillivant XR DMF (Drug Master File) is a document detailing the whole manufacturing process of Quillivant XR active pharmaceutical ingredient (API) in detail. Different forms of Quillivant XR DMFs exist exist since differing nations have different regulations, such as Quillivant XR USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Quillivant XR DMF submitted to regulatory agencies in the US is known as a USDMF. Quillivant XR USDMF includes data on Quillivant XR's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Quillivant XR USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Quillivant XR suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Quillivant XR Drug Master File in Japan (Quillivant XR JDMF) empowers Quillivant XR API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Quillivant XR JDMF during the approval evaluation for pharmaceutical products. At the time of Quillivant XR JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Quillivant XR suppliers with JDMF 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 Quillivant XR Drug Master File in Korea (Quillivant XR KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Quillivant XR. The MFDS reviews the Quillivant XR KDMF as part of the drug registration process and uses the information provided in the Quillivant XR KDMF to evaluate the safety and efficacy of the drug.
After submitting a Quillivant XR 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 Quillivant XR API can apply through the Korea Drug Master File (KDMF).
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A Quillivant XR CEP of the European Pharmacopoeia monograph is often referred to as a Quillivant XR Certificate of Suitability (COS). The purpose of a Quillivant XR CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Quillivant XR EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Quillivant XR to their clients by showing that a Quillivant XR CEP has been issued for it. The manufacturer submits a Quillivant XR CEP (COS) as part of the market authorization procedure, and it takes on the role of a Quillivant XR CEP holder for the record. Additionally, the data presented in the Quillivant XR CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Quillivant XR DMF.
A Quillivant XR CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Quillivant XR CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Quillivant XR suppliers with CEP (COS) on PharmaCompass.
A Quillivant XR written confirmation (Quillivant XR WC) is an official document issued by a regulatory agency to a Quillivant XR manufacturer, verifying that the manufacturing facility of a Quillivant XR active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Quillivant XR APIs or Quillivant XR finished pharmaceutical products to another nation, regulatory agencies frequently require a Quillivant XR WC (written confirmation) as part of the regulatory process.
click here to find a list of Quillivant XR 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 Quillivant XR as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Quillivant 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 Quillivant 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 Quillivant XR and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Quillivant XR NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Quillivant XR suppliers with NDC on PharmaCompass.
Quillivant 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 Quillivant XR 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 Quillivant XR GMP manufacturer or Quillivant XR GMP API supplier for your needs.
A Quillivant XR CoA (Certificate of Analysis) is a formal document that attests to Quillivant XR's compliance with Quillivant XR specifications and serves as a tool for batch-level quality control.
Quillivant XR CoA mostly includes findings from lab analyses of a specific batch. For each Quillivant 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.
Quillivant XR may be tested according to a variety of international standards, such as European Pharmacopoeia (Quillivant XR EP), Quillivant XR JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Quillivant XR USP).
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