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