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API SUPPLIERS
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USDMF
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Fillers, Diluents & Binders
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US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Protriptyline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Protriptyline, including repackagers and relabelers. The FDA regulates Protriptyline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Protriptyline 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 Protriptyline manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Protriptyline supplier is an individual or a company that provides Protriptyline active pharmaceutical ingredient (API) or Protriptyline finished formulations upon request. The Protriptyline suppliers may include Protriptyline API manufacturers, exporters, distributors and traders.
click here to find a list of Protriptyline suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Protriptyline DMF (Drug Master File) is a document detailing the whole manufacturing process of Protriptyline active pharmaceutical ingredient (API) in detail. Different forms of Protriptyline DMFs exist exist since differing nations have different regulations, such as Protriptyline USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Protriptyline DMF submitted to regulatory agencies in the US is known as a USDMF. Protriptyline USDMF includes data on Protriptyline's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Protriptyline USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Protriptyline suppliers with USDMF 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 Protriptyline as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Protriptyline 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 Protriptyline 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 Protriptyline and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Protriptyline NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Protriptyline suppliers with NDC on PharmaCompass.
Protriptyline 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 Protriptyline 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 Protriptyline GMP manufacturer or Protriptyline GMP API supplier for your needs.
A Protriptyline CoA (Certificate of Analysis) is a formal document that attests to Protriptyline's compliance with Protriptyline specifications and serves as a tool for batch-level quality control.
Protriptyline CoA mostly includes findings from lab analyses of a specific batch. For each Protriptyline 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.
Protriptyline may be tested according to a variety of international standards, such as European Pharmacopoeia (Protriptyline EP), Protriptyline JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Protriptyline USP).
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