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