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