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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
Basic Nutrition, your expert for sourcing from China, India and Europe.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
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USDMF
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Basic Nutrition, your expert for sourcing from China, India and Europe.
About the Company : As an ISO9001, ISO22000 certificated supplier, Basic Nutrition supply high-quality ingredients for nutraceuticals. We can offer a range of products from small to large quantites: h...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product ...
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
About the Company : Pharm-Rx has earned an outstanding reputation since its establishment in 1991, serving as a reputable importer and distributor of active ingredients to the pharmaceutical, nutritio...
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
About the Company : Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutical Ingredients (APIs)...
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
About the Company : Octavius Pharma is a global leader in Directly Compressible Granules with over 40 years of experience in Formulation development, manufacturing and commercialization. It offers a w...
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API Imports and Exports
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Drugs in Development
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - FOR SOLUTION;INTRAVENOUS - 80MG/VIAL...DOSAGE - FOR SOLUTION;INTRAVENOUS - 80MG/VIAL;0.02MG/VIAL;0.001MG/VIAL;5MG/VIAL;0.01MG/VIAL;0.14MG/VIAL;17MG/VIAL;0.2MG/VIAL;1MG/VIAL;1.4MG/VIAL;EQ 1.2MG BASE/VIAL;0.7MG/VIAL;7MG/VIAL
USFDA APPLICATION NUMBER - 18920
DOSAGE - SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/...DOSAGE - SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;0.03MG/ML
USFDA APPLICATION NUMBER - 21163
DOSAGE - SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/...DOSAGE - SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;30MCG/ML
USFDA APPLICATION NUMBER - 21163
DOSAGE - INJECTABLE;INTRAVENOUS - 200MG/VIAL;...DOSAGE - INJECTABLE;INTRAVENOUS - 200MG/VIAL;0.06MG/VIAL;0.005MG/VIAL;15MG/VIAL;0.005MG/VIAL;0.6MG/VIAL;40MG/VIAL;6MG/VIAL;3.6MG/VIAL;6MG/VIAL;1MG/VIAL;10MG/VIAL;0.15MG/VIAL
USFDA APPLICATION NUMBER - 21625
DOSAGE - INJECTABLE;INJECTION - 20MG/ML;0.006...DOSAGE - INJECTABLE;INJECTION - 20MG/ML;0.006MG/ML;0.05MCG/ML;1.5MG/ML;0.0005MG/ML;0.06MG/ML;4MG/ML;0.6MG/ML;0.36MG/ML;0.6MG/ML;0.1MG/ML;1MG/ML
USFDA APPLICATION NUMBER - 8809
Related Excipient Companies
Evonik
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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
Coating Systems & Additives
Direct Compression
Thickeners and Stabilizers
Solubilizers
Controlled & Modified Release
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
Dosage Form : Capsule, Granule / Pellet, Tablet
Grade : Oral
Brand Name : EUDRAGIT® L 100-55
Application : Coating Systems & Additives, Controlled & Modified Release, Solubilizers
Excipient Details : EUDRAGIT® L 100-55 (powder) is used in delayed release coatings to enhance solubility of poorly soluble drugs such as tablets, capsules & granules.
Pharmacopoeia Ref : NA
Technical Specs : NA
Ingredient(s) : Methacrylic Acid - Ethyl Acrylate Copolymer
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Application : Co-Processed Excipients, Controlled & Modified Release, Direct Compression
Excipient Details : DiCOM-DC SR300 is used as a directly compressible, rate-controlling, and co-processed excipient in sustained-release tablets and capsules.
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.
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
Dosage Form : Capsule, Granule / Pellet, Orodispersible Tablet, Powder, Tablet
Grade : Oral
Application : Coating Systems & Additives, Controlled & Modified Release, Disintegrants & Superdisintegrants, Film Formers & Plasticizers, Taste Masking
Excipient Details : EUDRAGIT® E 100 (granules) is an immediate-release polymer used as a taste masking, coating agent & film former in tablets, capsules, powders & ODTs.
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
Dosage Form : Tablet
Grade : Oral
Brand Name : EUDRAGIT® RS 12,5
Application : Controlled & Modified Release
Excipient Details : EUDRAGIT® RS 12,5 (Organic solution) is a sustained release polymer for customized release profiles used in combination with EUDRAGIT® RL.
Pharmacopoeia Ref : NA
Technical Specs : NA
Ingredient(s) : Ethyl Acrylate Methyl Methacrylate Copolymer
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Dosage Form : Capsule, Granule / Pellet, Tablet
Grade : Oral
Application : Controlled & Modified Release
Excipient Details : Gellets-P are Microcrystalline Cellulose based spheres for the manufacturing of pellets and modified release products.
Taste Masking
Disintegrants & Superdisintegrants
Parenteral
Granulation
Topical
Film Formers & Plasticizers
Lubricants & Glidants
Chewable & Orodispersible Aids
Co-Processed Excipients
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.
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, Fillers, Diluents & Binders, Taste Masking
Excipient Details : Compressol® SM, co-processed polyol, is a DC excipient of mannitol & sorbitol with superior compactibility, lower disintegration time & hygroscopicity
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Dosage Form : Tablet
Grade : Oral
Application : Co-Processed Excipients
Excipient Details : Mannitol is a co-processed excipient with superior compactibility, lower disintegration time, and hygroscopicity.
Boai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.
Application : Co-Processed Excipients
Excipient Details : WhiVidone is used as a co-processed excipient in dental and oral care applications such as gels, tablets, liquids, and films.
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Application : Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders
Excipient Details : STARLOSE is used as a diluent, binder, directly compressible (DC), and co-processed excipient in tablets and capsules.
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Brand Name : Microlose™ M60 P60
Application : Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders
Excipient Details : Microlose M60 P60 is used as a filler, binder, directly compressible, and co-processed excipient in tablets and capsules.
Pharmacopoeia Ref : In-house
Technical Specs : Lactose Monohydrate – 40%, Microcrystalline cellulose – 60%
Ingredient(s) : Lactose Monohydrate
Boai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.
Application : Co-Processed Excipients
Excipient Details : WhiVidone 30 is used as a co-processed excipient in dental and oral care applications such as gels, tablets, liquids, and films.
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Application : Co-Processed Excipients, Direct Compression, Disintegrants & Superdisintegrants, Fillers, Diluents & Binders, Lubricants & Glidants
Excipient Details : ProBlend (Microcrystalline Cellulose) is used as a filler, binder, glidant, DC & co-processed excipient in tablets, capsules, and MUPS formulations.
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Brand Name : DiCOM-DC® PL009 P60
Application : Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders
Excipient Details : DiCOM-DC PL009 P60 is used as a filler, binder, directly compressible, and co-processed excipient in tablets and capsules.
Emulsifying Agents
Rheology Modifiers
API Stability Enhancers
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 : Tablet, Orodispersible Tablet
Grade : Oral
Brand Name : Mannogem XL Mannitol
Application : API Stability Enhancers, Chewable & Orodispersible Aids, Fillers, Diluents & Binders
Excipient Details : Mannogem® XL is a DC spray-dried mannitol used to enhance mannitol formulation tabletability & provide superior binding & quick disintegration.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Application : API Stability Enhancers
Excipient Details : Effer-Soda is a surface modified sodium bicarbonate powder that eliminates formulation instability, expensive packaging & premature effervescence.
Empty Capsules
Surfactant & Foaming Agents
Coloring Agents
Vegetarian Capsules
Soft Gelatin
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
Market Place
REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
Analytical Methods
ABOUT THIS PAGE
A Folic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Folic Acid, including repackagers and relabelers. The FDA regulates Folic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Folic Acid 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 Folic Acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Folic Acid supplier is an individual or a company that provides Folic Acid active pharmaceutical ingredient (API) or Folic Acid finished formulations upon request. The Folic Acid suppliers may include Folic Acid API manufacturers, exporters, distributors and traders.
click here to find a list of Folic Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Folic Acid DMF (Drug Master File) is a document detailing the whole manufacturing process of Folic Acid active pharmaceutical ingredient (API) in detail. Different forms of Folic Acid DMFs exist exist since differing nations have different regulations, such as Folic Acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Folic Acid DMF submitted to regulatory agencies in the US is known as a USDMF. Folic Acid USDMF includes data on Folic Acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Folic Acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Folic Acid 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 Folic Acid Drug Master File in Japan (Folic Acid JDMF) empowers Folic Acid 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 Folic Acid JDMF during the approval evaluation for pharmaceutical products. At the time of Folic Acid 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 Folic Acid suppliers with JDMF on PharmaCompass.
A Folic Acid CEP of the European Pharmacopoeia monograph is often referred to as a Folic Acid Certificate of Suitability (COS). The purpose of a Folic Acid CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Folic Acid EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Folic Acid to their clients by showing that a Folic Acid CEP has been issued for it. The manufacturer submits a Folic Acid CEP (COS) as part of the market authorization procedure, and it takes on the role of a Folic Acid CEP holder for the record. Additionally, the data presented in the Folic Acid CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Folic Acid DMF.
A Folic Acid CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Folic Acid 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 Folic Acid suppliers with CEP (COS) on PharmaCompass.
A Folic Acid written confirmation (Folic Acid WC) is an official document issued by a regulatory agency to a Folic Acid manufacturer, verifying that the manufacturing facility of a Folic Acid active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Folic Acid APIs or Folic Acid finished pharmaceutical products to another nation, regulatory agencies frequently require a Folic Acid WC (written confirmation) as part of the regulatory process.
click here to find a list of Folic Acid 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 Folic Acid as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Folic Acid 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 Folic Acid 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 Folic Acid and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Folic Acid NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Folic Acid suppliers with NDC on PharmaCompass.
Folic Acid 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 Folic Acid 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 Folic Acid GMP manufacturer or Folic Acid GMP API supplier for your needs.
A Folic Acid CoA (Certificate of Analysis) is a formal document that attests to Folic Acid's compliance with Folic Acid specifications and serves as a tool for batch-level quality control.
Folic Acid CoA mostly includes findings from lab analyses of a specific batch. For each Folic Acid 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.
Folic Acid may be tested according to a variety of international standards, such as European Pharmacopoeia (Folic Acid EP), Folic Acid JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Folic Acid USP).
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