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