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