Synopsis
0
VMF
0
Europe
0
Australia
DRUG PRODUCT COMPOSITIONS0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - TABLET;ORAL - 10MG
USFDA APPLICATION NUMBER - 87846
DOSAGE - TABLET;ORAL - 25MG
USFDA APPLICATION NUMBER - 87846
DOSAGE - TABLET;ORAL - 50MG
USFDA APPLICATION NUMBER - 87846
Related Excipient Companies
SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Faran Shimi Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Boai NKY Pharmaceuticals Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pfanstiehl
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ACG Worldwide
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Aeon Procare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Corel Pharma Chem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DFE Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ideal Cures Pvt Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kima Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lonza Capsugel
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Bold Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nomisma Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Novo Excipients
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharmatrans-Sanaq
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Prachin Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qianhao Chemical (Hebei) Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qualicaps
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seppic
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Welltone Material Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]The Dow Chemical Company
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ulanqab Kema New Material
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Fillers, Diluents & Binders
Coating Systems & Additives
Controlled & Modified Release
Thickeners and Stabilizers
Direct Compression
Solubilizers
Granulation
Disintegrants & Superdisintegrants
Lubricants & Glidants
Film Formers & Plasticizers
Co-Processed Excipients
Topical
Parenteral
Taste Masking
Emulsifying Agents
API Stability Enhancers
Chewable & Orodispersible Aids
Coloring Agents
Rheology Modifiers
Empty Capsules
Vegetarian Capsules
Surfactant & Foaming Agents
Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
REF. STANDARDS & IMPURITIES
USP
ABOUT THIS PAGE
36
PharmaCompass offers a list of Imipramine 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 Imipramine Hydrochloride manufacturer or Imipramine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Imipramine Hydrochloride manufacturer or Imipramine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Imipramine Hydrochloride API Price utilized in the formulation of products. Imipramine Hydrochloride API Price is not always fixed or binding as the Imipramine Hydrochloride Price is obtained through a variety of data sources. The Imipramine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Imidol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Imidol, including repackagers and relabelers. The FDA regulates Imidol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Imidol 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 Imidol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Imidol supplier is an individual or a company that provides Imidol active pharmaceutical ingredient (API) or Imidol finished formulations upon request. The Imidol suppliers may include Imidol API manufacturers, exporters, distributors and traders.
click here to find a list of Imidol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Imidol DMF (Drug Master File) is a document detailing the whole manufacturing process of Imidol active pharmaceutical ingredient (API) in detail. Different forms of Imidol DMFs exist exist since differing nations have different regulations, such as Imidol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Imidol DMF submitted to regulatory agencies in the US is known as a USDMF. Imidol USDMF includes data on Imidol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Imidol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Imidol 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 Imidol Drug Master File in Japan (Imidol JDMF) empowers Imidol 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 Imidol JDMF during the approval evaluation for pharmaceutical products. At the time of Imidol 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 Imidol 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 Imidol Drug Master File in Korea (Imidol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Imidol. The MFDS reviews the Imidol KDMF as part of the drug registration process and uses the information provided in the Imidol KDMF to evaluate the safety and efficacy of the drug.
After submitting a Imidol 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 Imidol API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Imidol suppliers with KDMF on PharmaCompass.
A Imidol CEP of the European Pharmacopoeia monograph is often referred to as a Imidol Certificate of Suitability (COS). The purpose of a Imidol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Imidol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Imidol to their clients by showing that a Imidol CEP has been issued for it. The manufacturer submits a Imidol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Imidol CEP holder for the record. Additionally, the data presented in the Imidol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Imidol DMF.
A Imidol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Imidol 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 Imidol suppliers with CEP (COS) on PharmaCompass.
A Imidol written confirmation (Imidol WC) is an official document issued by a regulatory agency to a Imidol manufacturer, verifying that the manufacturing facility of a Imidol active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Imidol APIs or Imidol finished pharmaceutical products to another nation, regulatory agencies frequently require a Imidol WC (written confirmation) as part of the regulatory process.
click here to find a list of Imidol 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 Imidol as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Imidol 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 Imidol 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 Imidol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Imidol NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Imidol suppliers with NDC on PharmaCompass.
Imidol 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 Imidol 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 Imidol GMP manufacturer or Imidol GMP API supplier for your needs.
A Imidol CoA (Certificate of Analysis) is a formal document that attests to Imidol's compliance with Imidol specifications and serves as a tool for batch-level quality control.
Imidol CoA mostly includes findings from lab analyses of a specific batch. For each Imidol 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.
Imidol may be tested according to a variety of international standards, such as European Pharmacopoeia (Imidol EP), Imidol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Imidol USP).
