Synopsis
0
VMF
DRUG PRODUCT COMPOSITIONS
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]Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]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]Europe
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]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
Minakem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]PMC Isochem
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]Kewpie Corporation
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]Shanghai Minbiotech
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]Kirsch Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Panvo Organics
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]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ashland
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Bioplus Life Sciences
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]Esteem Industries
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]Gloria Interchem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ideal Cures
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]Keval Exports
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]Nitika Pharmaceutical Specialities
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 Pharmachem
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]Shijiazhuang Huaxu Pharmaceutical
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]Silverline Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Fillers, Diluents & Binders
Direct Compression
Thickeners and Stabilizers
Granulation
Solubilizers
Chewable & Orodispersible Aids
Taste Masking
Lubricants & Glidants
Coating Systems & Additives
Parenteral
Co-Processed Excipients
Disintegrants & Superdisintegrants
Emulsifying Agents
Empty Capsules
Topical
Controlled & Modified Release
Film Formers & Plasticizers
API Stability Enhancers
Surfactant & Foaming Agents
Rheology Modifiers
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
ABOUT THIS PAGE
25
PharmaCompass offers a list of Aprepitant API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Aprepitant manufacturer or Aprepitant supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Aprepitant manufacturer or Aprepitant supplier.
A Aprecap manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Aprecap, including repackagers and relabelers. The FDA regulates Aprecap manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Aprecap 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 Aprecap manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Aprecap supplier is an individual or a company that provides Aprecap active pharmaceutical ingredient (API) or Aprecap finished formulations upon request. The Aprecap suppliers may include Aprecap API manufacturers, exporters, distributors and traders.
click here to find a list of Aprecap suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Aprecap DMF (Drug Master File) is a document detailing the whole manufacturing process of Aprecap active pharmaceutical ingredient (API) in detail. Different forms of Aprecap DMFs exist exist since differing nations have different regulations, such as Aprecap USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Aprecap DMF submitted to regulatory agencies in the US is known as a USDMF. Aprecap USDMF includes data on Aprecap's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Aprecap USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Aprecap 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 Aprecap Drug Master File in Japan (Aprecap JDMF) empowers Aprecap 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 Aprecap JDMF during the approval evaluation for pharmaceutical products. At the time of Aprecap 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 Aprecap 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 Aprecap Drug Master File in Korea (Aprecap KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Aprecap. The MFDS reviews the Aprecap KDMF as part of the drug registration process and uses the information provided in the Aprecap KDMF to evaluate the safety and efficacy of the drug.
After submitting a Aprecap 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 Aprecap API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Aprecap suppliers with KDMF on PharmaCompass.
A Aprecap CEP of the European Pharmacopoeia monograph is often referred to as a Aprecap Certificate of Suitability (COS). The purpose of a Aprecap CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Aprecap EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Aprecap to their clients by showing that a Aprecap CEP has been issued for it. The manufacturer submits a Aprecap CEP (COS) as part of the market authorization procedure, and it takes on the role of a Aprecap CEP holder for the record. Additionally, the data presented in the Aprecap CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Aprecap DMF.
A Aprecap CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Aprecap 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 Aprecap suppliers with CEP (COS) on PharmaCompass.
A Aprecap written confirmation (Aprecap WC) is an official document issued by a regulatory agency to a Aprecap manufacturer, verifying that the manufacturing facility of a Aprecap active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Aprecap APIs or Aprecap finished pharmaceutical products to another nation, regulatory agencies frequently require a Aprecap WC (written confirmation) as part of the regulatory process.
click here to find a list of Aprecap 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 Aprecap as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Aprecap 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 Aprecap 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 Aprecap and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Aprecap NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Aprecap suppliers with NDC on PharmaCompass.
Aprecap 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 Aprecap GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Aprecap GMP manufacturer or Aprecap GMP API supplier for your needs.
A Aprecap CoA (Certificate of Analysis) is a formal document that attests to Aprecap's compliance with Aprecap specifications and serves as a tool for batch-level quality control.
Aprecap CoA mostly includes findings from lab analyses of a specific batch. For each Aprecap 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.
Aprecap may be tested according to a variety of international standards, such as European Pharmacopoeia (Aprecap EP), Aprecap JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Aprecap USP).
