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1. Cellcept
2. Mofetil Hydrochloride, Mycophenolate
3. Mofetil, Mycophenolate
4. Mycophenolate Mofetil
5. Mycophenolate Sodium
6. Mycophenolate, Sodium
7. Mycophenolic Acid
8. Mycophenolic Acid Morpholinoethyl Ester
9. Myfortic
10. Rs 61443
11. Rs-61443
12. Rs61443
13. Sodium Mycophenolate
1. 116680-01-4
2. Mycophenolate Mofetil Hcl
3. Mycophenolate Mofetil (hydrochloride)
4. Mycophenolate Mofetil Hydrochloride [usan]
5. Uxh81s8zvb
6. Rs-61443-190
7. Cellcept (tn)
8. 2-(4-morpholinyl)ethyl Ester (e)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoic Acid, Hydrochloride
9. 2-morpholin-4-ylethyl (e)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1h-2-benzofuran-5-yl)-4-methylhex-4-enoate;hydrochloride
10. 2-morpholinoethyl (e)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-5-phthalanyl)-4-methyl-4-hexenoate Hydrochloride
11. 2-morpholin-4-ylethyl (e)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1h-isobenzofuran-5-yl)-4-methyl-hex-4-enoate Hydrochloride
12. Mycophenolate Mofetil Hydrochloride (usan)
13. Unii-uxh81s8zvb
14. Rs 61443-190
15. Mycophenolatemofetilhydrochloride
16. Schembl1235420
17. Chembl1200955
18. Hy-b0199a
19. Dtxsid101027191
20. Akos000280984
21. 4-hexenoic Acid, 6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-, 2-(4-morpholinyl)ethyl Ester, Hydrochloride, (4e)-
22. 4-hexenoic Acid, 6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-, 2-(4-morpholinyl)ethyl Ester, Hydrochloride, (e)-
23. D05094
24. Mycophenolate Mofetil Hydrochloride [mart.]
25. Mycophenolate Mofetil Hydrochloride [vandf]
26. Mycophenolate Mofetil Hydrochloride [who-dd]
27. Q27291325
28. Mycophenolate Mofetil Hydrochloride [orange Book]
29. 2-morpholin-4-ylethyl (e)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1h-isobenzofuran-5-yl)-4-methyl-hex-
Molecular Weight | 470.0 g/mol |
---|---|
Molecular Formula | C23H32ClNO7 |
Hydrogen Bond Donor Count | 2 |
Hydrogen Bond Acceptor Count | 8 |
Rotatable Bond Count | 10 |
Exact Mass | 469.1867301 g/mol |
Monoisotopic Mass | 469.1867301 g/mol |
Topological Polar Surface Area | 94.5 Ų |
Heavy Atom Count | 32 |
Formal Charge | 0 |
Complexity | 646 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 1 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
1 of 2 | |
---|---|
Drug Name | Mycophenolate mofetil hydrochloride |
Drug Label | CellCept (mycophenolate mofetil) is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor.The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6... |
Active Ingredient | Mycophenolate mofetil hydrochloride |
Dosage Form | Injectable |
Route | injection |
Strength | 500mg |
Market Status | Tentative Approval |
Company | Bedford Labs |
2 of 2 | |
---|---|
Drug Name | Mycophenolate mofetil hydrochloride |
Drug Label | CellCept (mycophenolate mofetil) is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor.The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6... |
Active Ingredient | Mycophenolate mofetil hydrochloride |
Dosage Form | Injectable |
Route | injection |
Strength | 500mg |
Market Status | Tentative Approval |
Company | Bedford Labs |
Enzyme Inhibitors
Compounds or agents that combine with an enzyme in such a manner as to prevent the normal substrate-enzyme combination and the catalytic reaction. (See all compounds classified as Enzyme Inhibitors.)
Antibiotics, Antineoplastic
Chemical substances, produced by microorganisms, inhibiting or preventing the proliferation of neoplasms. (See all compounds classified as Antibiotics, Antineoplastic.)
Antibiotics, Antitubercular
Substances obtained from various species of microorganisms that are, alone or in combination with other agents, of use in treating various forms of tuberculosis; most of these agents are merely bacteriostatic, induce resistance in the organisms, and may be toxic. (See all compounds classified as Antibiotics, Antitubercular.)
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
MYCOPHENOLATE MOFETIL HYDROCHLORIDE
NDC Package Code : 52076-6235
Start Marketing Date : 2018-01-10
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
Regulatory Info :
Registration Country : Switzerland
Brand Name : CellCept (PI)
Dosage Form : Kaps
Dosage Strength : 250mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : CellCept (PI)
Dosage Form : Filmtabl
Dosage Strength : 500mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info : RX
Registration Country : USA
MYCOPHENOLATE MOFETIL HYDROCHLORIDE
Brand Name : MYCOPHENOLATE MOFETIL HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 500MG/VIAL
Packaging :
Approval Date : 2016-10-28
Application Number : 203575
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
MYCOPHENOLATE MOFETIL HYDROCHLORIDE
Brand Name : CELLCEPT
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 500MG/VIAL
Packaging :
Approval Date : 1998-08-12
Application Number : 50758
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Switzerland
Brand Name : Cellcept
Dosage Form : Susp
Dosage Strength : 200mg/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Cellcept
Dosage Form : Filmtabl
Dosage Strength : 500mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info : Prescription
Registration Country : Canada
MYCOPHENOLATE MOFETIL (MYCOPHENOLATE MOFETIL HYDROCHLORIDE)
Brand Name : CELLCEPT I.V.
Dosage Form : POWDER FOR SOLUTION
Dosage Strength : 500MG/VIAL
Packaging : 20 ML
Approval Date :
Application Number : 2240347
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : RX
Registration Country : USA
MYCOPHENOLATE MOFETIL HYDROCHLORIDE
Brand Name : MYCOPHENOLATE MOFETIL HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 500MG/VIAL
Packaging :
Approval Date : 2021-01-15
Application Number : 212130
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Switzerland
Brand Name : Myfortic
Dosage Form : Film-Coated Tablets
Dosage Strength : 180mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Myfenax
Dosage Form : Caps
Dosage Strength : 250mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Related Excipient Companies
Excipients by Applications
Dosage Form : Capsule, Cream / Lotion / Ointment, Emulsion, Gel, Injectable / Parenteral, Suspension, Tablet
Grade : Parenteral, Oral, Topical
Category : Emulsifying Agents, Film Formers & Plasticizers, Parenteral, Solubilizers, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical
Application : Emulsifying Agents, Film Formers & Plasticizers, Parenteral, Solubilizers, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical
Excipient Details : Polysorbate 80 is used as a plasticizer, solubilizer, emulsifier, surfactant, and suspension stabilizer. It is also used in parenteral products.
Dosage Form : Emulsion, Injectable / Parenteral
Grade : Parenteral
Category : Emulsifying Agents, Parenteral, Solubilizers
Dosage Form : Cream / Lotion / Ointment, Gel, Injectable / Parenteral, Softgel Capsule, Softgels
Grade : Parenteral, Topical, Oral
Category : Fillers, Diluents & Binders, Film Formers & Plasticizers, Parenteral, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical
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.
Dosage Form : Capsule, Cream / Lotion / Ointment, Suspension, Tablet
Grade : Oral, Topical & Parenteral
Category : Solubilizers, Surfactant & Foaming Agents
Application : Solubilizers, Surfactant & Foaming Agents
Excipient Details : Polysorbate 80 acts as solubilizer, emulsifier and wetting agent.
Dosage Form : Capsule, Cream / Lotion / Ointment, Gel, Tablet
Grade : Topical and Oral
Category : Controlled & Modified Release, Topical
Brand Name : Polyethylene Glycol 400
Application : Controlled & Modified Release, Topical
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : polyethylene glycol
Brand Name : Hydrochloric Acid NF
Application : Parenteral
Excipient Details : A&C's Hydrochloric Acid NF is used as a low pH neutralizing agent for pharmaceutical applications.
Brand Name : Polyethylene Glycol 400
Application : Topical
Excipient Details : A&C's Polyethylene Glycol 400 USP-NF is a short chain non-ionic surfactant.
Pharmacopoeia Ref : Not Available
Technical Specs : Low Endotoxin
Ingredient(s) : polyethylene glycol
Brand Name : NEOSORB® BIOPHARMA
Application : Parenteral
Excipient Details : Suitable for use in biopharmaceutical manufacturing and as an excipient for injectable dosage forms
Pharmacopoeia Ref : USP/EP/JP
Technical Specs : Not Available
Ingredient(s) : Sorbitol, low endotoxin
Dosage Form : Injectable / Parenteral, Nasal Solution, Ophthalmic Solution
Grade : Injectable
Category : Parenteral, Solubilizers
Application : Parenteral, Solubilizers
Excipient Details : Non-Ionic Hydrophilic Surfactant, Emulsifier, Solubilizer
Dosage Form : Injectable / Parenteral, Nasal Solution, Ophthalmic Solution
Grade : Injectable
Category : Parenteral, Solubilizers
Application : Parenteral, Solubilizers
Excipient Details : Non-Ionic Hydrophilic Surfactant, Emulsifier, Solubilizer
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214283
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216390
21 Nov 2015
// Sarah N. Lynch REUTERS
http://www.reuters.com/article/2015/11/20/us-novartis-pharmacies-kickbacks-idUSKCN0T92MR20151120?rpc=401#cf1zEqDuzgY1HpGE.97
12 Jan 2015
// HEALTH CANADA
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2016/56690a-eng.php
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10 Oct 2019
ABOUT THIS PAGE
21
PharmaCompass offers a list of Mycophenolate Mofetil 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 Mycophenolate Mofetil Hydrochloride manufacturer or Mycophenolate Mofetil Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Mycophenolate Mofetil Hydrochloride manufacturer or Mycophenolate Mofetil Hydrochloride supplier.
PharmaCompass also assists you with knowing the Mycophenolate Mofetil Hydrochloride API Price utilized in the formulation of products. Mycophenolate Mofetil Hydrochloride API Price is not always fixed or binding as the Mycophenolate Mofetil Hydrochloride Price is obtained through a variety of data sources. The Mycophenolate Mofetil Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Mycophenolate Mofetil Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mycophenolate Mofetil Hydrochloride, including repackagers and relabelers. The FDA regulates Mycophenolate Mofetil Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mycophenolate Mofetil Hydrochloride 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 Mycophenolate Mofetil Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mycophenolate Mofetil Hydrochloride supplier is an individual or a company that provides Mycophenolate Mofetil Hydrochloride active pharmaceutical ingredient (API) or Mycophenolate Mofetil Hydrochloride finished formulations upon request. The Mycophenolate Mofetil Hydrochloride suppliers may include Mycophenolate Mofetil Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Mycophenolate Mofetil Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mycophenolate Mofetil Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Mycophenolate Mofetil Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Mycophenolate Mofetil Hydrochloride DMFs exist exist since differing nations have different regulations, such as Mycophenolate Mofetil Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mycophenolate Mofetil Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Mycophenolate Mofetil Hydrochloride USDMF includes data on Mycophenolate Mofetil Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mycophenolate Mofetil Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mycophenolate Mofetil Hydrochloride 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 Mycophenolate Mofetil Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Mycophenolate Mofetil Hydrochloride 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 Mycophenolate Mofetil Hydrochloride 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 Mycophenolate Mofetil Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Mycophenolate Mofetil Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Mycophenolate Mofetil Hydrochloride suppliers with NDC on PharmaCompass.
Mycophenolate Mofetil Hydrochloride 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 Mycophenolate Mofetil Hydrochloride 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 Mycophenolate Mofetil Hydrochloride GMP manufacturer or Mycophenolate Mofetil Hydrochloride GMP API supplier for your needs.
A Mycophenolate Mofetil Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Mycophenolate Mofetil Hydrochloride's compliance with Mycophenolate Mofetil Hydrochloride specifications and serves as a tool for batch-level quality control.
Mycophenolate Mofetil Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Mycophenolate Mofetil Hydrochloride 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.
Mycophenolate Mofetil Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Mycophenolate Mofetil Hydrochloride EP), Mycophenolate Mofetil Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Mycophenolate Mofetil Hydrochloride USP).