Synopsis
0
CEP/COS
0
KDMF
0
VMF
0
EDQM
0
USP
0
JP
0
Others
0
Australia
0
South Africa
DRUG PRODUCT COMPOSITIONS0
FDF
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]EU WC
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]DRUG PRODUCT COMPOSITIONS
DOSAGE - FOR SOLUTION;ORAL - 120GM/PACKET;1.4...DOSAGE - FOR SOLUTION;ORAL - 120GM/PACKET;1.49GM/PACKET;3.36GM/PACKET;2.92GM/PACKET;11.36GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 18983
DOSAGE - FOR SOLUTION;ORAL - 227.1GM/PACKET;2...DOSAGE - FOR SOLUTION;ORAL - 227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 18983
DOSAGE - FOR SOLUTION;ORAL - 240GM/BOT;2.98GM...DOSAGE - FOR SOLUTION;ORAL - 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 18983
DOSAGE - FOR SOLUTION;ORAL - 360GM/PACKET;4.4...DOSAGE - FOR SOLUTION;ORAL - 360GM/PACKET;4.47GM/PACKET;10.08GM/PACKET;8.76GM/PACKET;34.08GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 18983
DOSAGE - FOR SOLUTION;ORAL - 420GM/BOT;1.48GM...DOSAGE - FOR SOLUTION;ORAL - 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT
USFDA APPLICATION NUMBER - 19797
Related Excipient Companies
EUROAPI
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Evonik
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]Pharm-RX Chemical
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]Capital Farma
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]Dr. Paul Lohmann GmbH & Co. KGaA
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]CD Formulation
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Clariant
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]Doshion Polyscience
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]JJ Chemicals
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]Neelkanth MineChem
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]Pluviaendo
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]Shandong Focus Biotechnology Co., Ltd
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]The Dow Chemical Company
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Valens Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Zhejiang Huakang Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Parenteral
Coating Systems & Additives
Fillers, Diluents & Binders
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Dosage Form : Tablet
Grade : Oral
Application : Fillers, Diluents & Binders
Excipient Details : Mpressol (Mannitol) is a polyol used as a filler in tablet formulations, sugar-free solutions and as a bulking agent in freeze-dried products.
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Dosage Form : Tablet
Grade : Oral
Brand Name : Calcium Lactate-Glycerol Adduct
Application : Fillers, Diluents & Binders
Excipient Details : Calcium lactate-glycerol adduct is used both as a stabilizer and a binder in tablet formulations.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Dosage Form : Cream / Lotion / Ointment, Emulsion, Gel, Solution, Tablet
Grade : Topical, Oral
Application : API Stability Enhancers, Emulsifying Agents, Fillers, Diluents & Binders
Excipient Details : Acacia, also known as gum arabic, is used in the pharmaceutical industry as an emulsifier, stabilizing agent, & tablet binder in various formulations.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Granule / Pellet, Tablet
Grade : Oral
Application : Fillers, Diluents & Binders, Granulation, Solubilizers
Excipient Details : Mannogem (mannitol powder) is an excellent excipient for use in wet granulation, lyophilization & improves solubility of poorly soluble APIs.
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Cream / Lotion / Ointment, Gel, Injectable / Parenteral, Softgel Capsule, Softgels
Grade : Parenteral, Topical, Oral
Brand Name : Polyethylene Glycol 400
Application : Fillers, Diluents & Binders, Film Formers & Plasticizers, Parenteral, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical
Excipient Details : PEG 400 is used as a suspending agent, stabilizer, plasticizer and filler in OSDs, liquids & semi-solids and as a solvent for parenteral formulations.
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
Dosage Form : Injectable / Parenteral, Tablet
Grade : Parenteral, Oral
Application : Fillers, Diluents & Binders, Parenteral, Thickeners and Stabilizers
Excipient Details : D-Mannitol protects proteins from denaturation & degradation. It is used as a stabilizer in liquid products including biologic injectables & vaccines.
Pharmacopoeia Ref : USP, EP, BP, JP, ChP
Technical Specs : Low Endotoxin, Low Metals
Ingredient(s) : Mannitol
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet, Tablet
Grade : Oral
Application : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders, Taste Masking
Excipient Details : Pharmaburst® 500 is a directly compressible, co-processed pharmaceutical excipient used to create orally disintegrating tablets quickly and easily.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Dosage Form : Tablet
Grade : Oral
Application : Fillers, Diluents & Binders, Taste Masking
Excipient Details : Mannitol is used as a filler, bulking agent and taste masking agent in ODT formulations such as tablets.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Dosage Form : Cream / Lotion / Ointment, Gel, Orodispersible Tablet, Tablet
Grade : Topical, Oral
Application : API Stability Enhancers, Disintegrants & Superdisintegrants, Fillers, Diluents & Binders, Thickeners and Stabilizers
Excipient Details : Guar gum is used in oral solid dosage forms as a binder and disintegrant. It is also used as a suspending and thickening agent in topical products.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet, Orodispersible Tablet
Grade : Oral
Application : Chewable & Orodispersible Aids, Co-Processed Excipients, Direct Compression, Disintegrants & Superdisintegrants, Fillers, Diluents & Binders, Taste Masking
Excipient Details : Advantol® 300 is a DC pharmaceutical excipient used to create soft chew or fast melt oral dosage forms through co-processing technology.
Taste Masking
Film Formers & Plasticizers
Topical
Chewable & Orodispersible Aids
Thickeners and Stabilizers
Solubilizers
Direct Compression
Controlled & Modified Release
API Stability Enhancers
Disintegrants & Superdisintegrants
Granulation
Emulsifying Agents
Surfactant & Foaming Agents
Empty Capsules
Co-Processed Excipients
Vegetarian Capsules
Lubricants & Glidants
Rheology Modifiers
Coloring Agents
Soft Gelatin
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
Market Place
ANALYTICAL
Analytical Methods
ABOUT THIS PAGE
38
PharmaCompass offers a list of Lauromacrogol 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 Lauromacrogol manufacturer or Lauromacrogol supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Lauromacrogol manufacturer or Lauromacrogol supplier.
A Miralax manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Miralax, including repackagers and relabelers. The FDA regulates Miralax manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Miralax 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 Miralax manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Miralax supplier is an individual or a company that provides Miralax active pharmaceutical ingredient (API) or Miralax finished formulations upon request. The Miralax suppliers may include Miralax API manufacturers, exporters, distributors and traders.
click here to find a list of Miralax suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Miralax DMF (Drug Master File) is a document detailing the whole manufacturing process of Miralax active pharmaceutical ingredient (API) in detail. Different forms of Miralax DMFs exist exist since differing nations have different regulations, such as Miralax USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Miralax DMF submitted to regulatory agencies in the US is known as a USDMF. Miralax USDMF includes data on Miralax's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Miralax USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Miralax 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 Miralax Drug Master File in Japan (Miralax JDMF) empowers Miralax 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 Miralax JDMF during the approval evaluation for pharmaceutical products. At the time of Miralax 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 Miralax suppliers with JDMF on PharmaCompass.
A Miralax written confirmation (Miralax WC) is an official document issued by a regulatory agency to a Miralax manufacturer, verifying that the manufacturing facility of a Miralax active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Miralax APIs or Miralax finished pharmaceutical products to another nation, regulatory agencies frequently require a Miralax WC (written confirmation) as part of the regulatory process.
click here to find a list of Miralax 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 Miralax as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Miralax 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 Miralax 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 Miralax and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Miralax NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Miralax suppliers with NDC on PharmaCompass.
Miralax 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 Miralax GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Miralax GMP manufacturer or Miralax GMP API supplier for your needs.
A Miralax CoA (Certificate of Analysis) is a formal document that attests to Miralax's compliance with Miralax specifications and serves as a tool for batch-level quality control.
Miralax CoA mostly includes findings from lab analyses of a specific batch. For each Miralax 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.
Miralax may be tested according to a variety of international standards, such as European Pharmacopoeia (Miralax EP), Miralax JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Miralax USP).
