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