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API SUPPLIERS
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USDMF
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DOSAGE - TABLET;ORAL - 100MG
USFDA APPLICATION NUMBER - 85968
DOSAGE - TABLET;ORAL - 10MG
USFDA APPLICATION NUMBER - 85968
DOSAGE - TABLET;ORAL - 150MG
USFDA APPLICATION NUMBER - 85968
DOSAGE - TABLET;ORAL - 25MG
USFDA APPLICATION NUMBER - 85968
DOSAGE - TABLET;ORAL - 50MG
USFDA APPLICATION NUMBER - 85968
DOSAGE - TABLET;ORAL - 75MG
USFDA APPLICATION NUMBER - 85968
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ABOUT THIS PAGE
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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 Amyline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amyline, including repackagers and relabelers. The FDA regulates Amyline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amyline 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 Amyline manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Amyline supplier is an individual or a company that provides Amyline active pharmaceutical ingredient (API) or Amyline finished formulations upon request. The Amyline suppliers may include Amyline API manufacturers, exporters, distributors and traders.
click here to find a list of Amyline suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Amyline DMF (Drug Master File) is a document detailing the whole manufacturing process of Amyline active pharmaceutical ingredient (API) in detail. Different forms of Amyline DMFs exist exist since differing nations have different regulations, such as Amyline USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Amyline DMF submitted to regulatory agencies in the US is known as a USDMF. Amyline USDMF includes data on Amyline's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Amyline USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Amyline 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 Amyline Drug Master File in Japan (Amyline JDMF) empowers Amyline 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 Amyline JDMF during the approval evaluation for pharmaceutical products. At the time of Amyline 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 Amyline 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 Amyline Drug Master File in Korea (Amyline KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Amyline. The MFDS reviews the Amyline KDMF as part of the drug registration process and uses the information provided in the Amyline KDMF to evaluate the safety and efficacy of the drug.
After submitting a Amyline 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 Amyline API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Amyline suppliers with KDMF on PharmaCompass.
A Amyline CEP of the European Pharmacopoeia monograph is often referred to as a Amyline Certificate of Suitability (COS). The purpose of a Amyline CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Amyline EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Amyline to their clients by showing that a Amyline CEP has been issued for it. The manufacturer submits a Amyline CEP (COS) as part of the market authorization procedure, and it takes on the role of a Amyline CEP holder for the record. Additionally, the data presented in the Amyline CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Amyline DMF.
A Amyline CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Amyline 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 Amyline suppliers with CEP (COS) on PharmaCompass.
A Amyline written confirmation (Amyline WC) is an official document issued by a regulatory agency to a Amyline manufacturer, verifying that the manufacturing facility of a Amyline active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Amyline APIs or Amyline finished pharmaceutical products to another nation, regulatory agencies frequently require a Amyline WC (written confirmation) as part of the regulatory process.
click here to find a list of Amyline 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 Amyline as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Amyline 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 Amyline 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 Amyline and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Amyline NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Amyline suppliers with NDC on PharmaCompass.
Amyline 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 Amyline 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 Amyline GMP manufacturer or Amyline GMP API supplier for your needs.
A Amyline CoA (Certificate of Analysis) is a formal document that attests to Amyline's compliance with Amyline specifications and serves as a tool for batch-level quality control.
Amyline CoA mostly includes findings from lab analyses of a specific batch. For each Amyline 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.
Amyline may be tested according to a variety of international standards, such as European Pharmacopoeia (Amyline EP), Amyline JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Amyline USP).
