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