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1. Magnesium Citrate Dibasic, Anhydrous
2. 144-23-0
3. 7779-25-1
4. Magnesiumcitrate(x:1)
5. Magnesium Citrate(x:1)
6. Akos028109527
7. J-007935
| Molecular Weight | 214.41 g/mol |
|---|---|
| Molecular Formula | C6H6MgO7 |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 7 |
| Rotatable Bond Count | 3 |
| Exact Mass | 213.9963942 g/mol |
| Monoisotopic Mass | 213.9963942 g/mol |
| Topological Polar Surface Area | 138 Ų |
| Heavy Atom Count | 14 |
| Formal Charge | 0 |
| Complexity | 234 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 1 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
Dr. Paul Lohmann® provides premium mineral salts backed by 140+ years of innovation, quality manufacturing, and global expertise.
Certificate Number : R1-CEP 2009-017 - Rev 03
Issue Date : 2021-10-29
Type : Chemical
Substance Number : 2339
Status : Valid
Dr. Paul Lohmann® provides premium mineral salts backed by 140+ years of innovation, quality manufacturing, and global expertise.
Certificate Number : CEP 2011-036 - Rev 03
Issue Date : 2025-01-03
Type : Chemical
Substance Number : 2402
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 42215
Submission : 2025-08-23
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41377
Submission : 2025-06-05
Status : Active
Type : IV
Date of Issue : 2026-01-12
Valid Till : 2028-02-02
Written Confirmation Number : WC-0518
Address of the Firm :

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 43151
Submission : 2025-11-29
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35749
Submission : 2021-03-29
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35750
Submission : 2021-03-29
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27073
Submission : 2013-04-08
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 42662
Submission : 2025-09-26
Status : Active
Type : IV

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
Date of Issue : 2026-01-12
Valid Till : 2028-02-02
Written Confirmation Number : WC-0518
Address of the Firm : J-63, ROAD NO. U-6, MIDC Taloja, Taluka: Panvel, Raigad- 410208, Maharashtra Sta...

Date of Issue : 2026-01-12
Valid Till : 2028-02-02
Written Confirmation Number : WC-0518
Address of the Firm : J-63, ROAD NO. U-6, MIDC Taloja, Taluka: Panvel, Raigad- 410208, Maharashtra Sta...

Date of Issue : 2026-03-27
Valid Till : 2029-11-14
Written Confirmation Number : WC-0573
Address of the Firm : Unit-lll, 19 & 19B, SIPCOT Industrial Complex, Hosur-635126, Tamil Nadu, India

Date of Issue : 2026-03-27
Valid Till : 2029-11-14
Written Confirmation Number : WC-0573
Address of the Firm : Unit-lll, 19 & 19B, SIPCOT Industrial Complex, Hosur-635126, Tamil Nadu, India

Date of Issue : 2025-07-22
Valid Till : 2028-07-07
Written Confirmation Number : WC-0104
Address of the Firm : 124, 125 and 126, SIPCOT Industrial Complex, Hosur -635126, Tamil Nadu, India

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Details:
MTP-101P is a drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Pitt-Hopkins syndrome.
Lead Product(s): MTP-101P,Vancomycin Hydrochloride,Trimagnesium Dicitrate,Antacid
Therapeutic Area: Rare Diseases and Disorders Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Undisclosed
Sponsor: Pitt Hopkins Research Foundation
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 20, 2024

Lead Product(s) : MTP-101P,Vancomycin Hydrochloride,Trimagnesium Dicitrate,Antacid
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Pitt Hopkins Research Foundation
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : MTP-101P is a drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Pitt-Hopkins syndrome.
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Inapplicable
March 20, 2024

Details:
Vitamin K1 is a Vitamins/Minerals/Inorganic Salts drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Calciphylaxis.
Lead Product(s): Vitamin K1,Sodium Chloride,Trimagnesium Dicitrate,Sodium Thiosulfate
Therapeutic Area: Rare Diseases and Disorders Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Vitamins/Minerals/Inorganic Salts
Sponsor: Australasian Kidney Trials Network | Northern Care Alliance NHS Foundation Trust | Waitemata District Health Board
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 24, 2021

Lead Product(s) : Vitamin K1,Sodium Chloride,Trimagnesium Dicitrate,Sodium Thiosulfate
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Australasian Kidney Trials Network | Northern Care Alliance NHS Foundation Trust | Waitemata District Health Board
Deal Size : Inapplicable
Deal Type : Inapplicable
Better Evidence and Translation for Calciphylaxis
Details : Vitamin K1 is a Vitamins/Minerals/Inorganic Salts drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Calciphylaxis.
Product Name : Undisclosed
Product Type : Vitamins/Minerals/Inorganic Salts
Upfront Cash : Inapplicable
August 24, 2021

Details:
Magnesium Citrate is a Vitamins/Minerals/Inorganic Salts drug candidate, which is currently being evaluated in clinical studies for the treatment of Restless Legs Syndrome.
Lead Product(s): Trimagnesium Dicitrate,Inapplicable
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Vitamins/Minerals/Inorganic Salts
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 08, 2020

Lead Product(s) : Trimagnesium Dicitrate,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
The Effect of Magnesium Citrate Supplementation in Restless Legs Syndrome (RLS)
Details : Magnesium Citrate is a Vitamins/Minerals/Inorganic Salts drug candidate, which is currently being evaluated in clinical studies for the treatment of Restless Legs Syndrome.
Product Name : Undisclosed
Product Type : Vitamins/Minerals/Inorganic Salts
Upfront Cash : Inapplicable
July 08, 2020

Details:
Magnesium Citrate is a Vitamins/Minerals/Inorganic Salts drug candidate, which is currently being evaluated in clinical studies for the treatment of Vascular Stiffness.
Lead Product(s): Trimagnesium Dicitrate,Inapplicable
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Vitamins/Minerals/Inorganic Salts
Sponsor: Nedmag Industries Mining and Manufacturing B.V.
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 15, 2018

Lead Product(s) : Trimagnesium Dicitrate,Inapplicable
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : Nedmag Industries Mining and Manufacturing B.V.
Deal Size : Inapplicable
Deal Type : Inapplicable
Magnesium and Vascular Stiffness
Details : Magnesium Citrate is a Vitamins/Minerals/Inorganic Salts drug candidate, which is currently being evaluated in clinical studies for the treatment of Vascular Stiffness.
Product Name : Undisclosed
Product Type : Vitamins/Minerals/Inorganic Salts
Upfront Cash : Inapplicable
August 15, 2018

Details:
Magnesium Citrate is a Vitamins/Minerals/Inorganic Salts drug candidate, which is currently being evaluated in clinical studies for the treatment of undefined medical condition.
Lead Product(s): Trimagnesium Dicitrate,Dulcolax Tablets
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Vitamins/Minerals/Inorganic Salts
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 11, 2017

Lead Product(s) : Trimagnesium Dicitrate,Dulcolax Tablets
Therapeutic Area : Undisclosed
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Testing How Well Magnesium Citrate Capsules Work as Preparation for a Colonoscopy
Details : Magnesium Citrate is a Vitamins/Minerals/Inorganic Salts drug candidate, which is currently being evaluated in clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Vitamins/Minerals/Inorganic Salts
Upfront Cash : Inapplicable
August 11, 2017

Details:
Magnesium Citrate is a Vitamins/Minerals/Inorganic Salts drug candidate, which is currently being evaluated in clinical studies for the treatment of Diabetes Mellitus.
Lead Product(s): Trimagnesium Dicitrate,Inapplicable
Therapeutic Area: Endocrinology Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Vitamins/Minerals/Inorganic Salts
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 23, 2016

Lead Product(s) : Trimagnesium Dicitrate,Inapplicable
Therapeutic Area : Endocrinology
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Magnesium Supplementation in Type II Diabetes
Details : Magnesium Citrate is a Vitamins/Minerals/Inorganic Salts drug candidate, which is currently being evaluated in clinical studies for the treatment of Diabetes Mellitus.
Product Name : Undisclosed
Product Type : Vitamins/Minerals/Inorganic Salts
Upfront Cash : Inapplicable
December 23, 2016

Details:
Magnesium Citrate is a Vitamins/Minerals/Inorganic Salts drug candidate, which is currently being evaluated in phase I/ phase II clinical studies for the treatment of Essential Hypertension.
Lead Product(s): Trimagnesium Dicitrate,Inapplicable
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed
Study Phase: Phase I/ Phase IIProduct Type: Vitamins/Minerals/Inorganic Salts
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 04, 2016

Lead Product(s) : Trimagnesium Dicitrate,Inapplicable
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Safety Study of RMJH-111b to Treat Essential Hypertension
Details : Magnesium Citrate is a Vitamins/Minerals/Inorganic Salts drug candidate, which is currently being evaluated in phase I/ phase II clinical studies for the treatment of Essential Hypertension.
Product Name : Undisclosed
Product Type : Vitamins/Minerals/Inorganic Salts
Upfront Cash : Inapplicable
July 04, 2016

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
Dosage Form : Capsule
Grade : Topical, Oral
Dosage Form : Emulsion
Grade : Parenteral
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Dosage Form : Capsule
Grade : Not Available
Application : Solubilizers
Excipient Details : Solubilizing matrix, crystallization inhibitor & stabilizer in injectables and ophthalmic products
Dosage Form : Capsule
Grade : Not Available
Application : Solubilizers
Excipient Details : Solubilizing matrix, crystallization inhibitor & stabilizer in injectables and ophthalmic products
Pharmacopoeia Ref : Ph. Eur., USP: Povidone; JPE: ...
Technical Specs : Not Available
Ingredient(s) : Povidone
Dosage Form : Tablet
Grade : Not Available
Application : Controlled & Modified Release
Excipient Details : Solubilization, dispersion, crystallization inhibition, instant release matrices & spray drying
Dosage Form : Tablet
Grade : Not Available
Application : Solubilizers
Excipient Details : Solubilization, dispersion, crystallization inhibition, instant release matrices & spray drying
Pharmacopoeia Ref : Ph. Eur., USP, JP: Povidone
Technical Specs : Not Available
Ingredient(s) : Povidone
Dosage Form : Tablet
Grade : Not Available
Application : Fillers, Diluents & Binders
Excipient Details : Binder for peroxide sensitive drugs in solid oral dosage forms. Drug solubilizer with low peroxide in transdermal patches.
Pharmacopoeia Ref : Ph. Eur., USP, JP: Povidone
Technical Specs : Not Available
Ingredient(s) : Povidone
Excipients Web Link
Dosage Form : Capsule
Grade : Not Available
Application : Fillers, Diluents & Binders
Excipient Details : Tablet binding, thickener, stabilizers of suspensions, reduces sedimentation, crystallization inhibition.
Pharmacopoeia Ref : Ph. Eur., USP, JP: Povidone
Technical Specs : Not Available
Ingredient(s) : Povidone
Dosage Form : Tablet
Grade : Not Available
Application : Granulation
Excipient Details : For non-erodible matrices using direct compression, Controlled release matrix. Matrix former in transdermal patches and topical films.
Pharmacopoeia Ref : Ph. Eur., USP-NF, JP-JPE: 80 %...
Technical Specs : Not Available
Ingredient(s) : Povidone
Dosage Form : Emulsion
Grade : Not Available
Brand Name : Kollisolv PEG 300
Application : Solubilizers
Excipient Details : Liquid plasticizer, solvent for oral and topical applications, hydrophilic fill for solubilization of hydrophilic APIs.
Pharmacopoeia Ref : Ph. Eur., JP, FCC, USP
Technical Specs : Not Available
Ingredient(s) : Polyethylene Glycol Excipient
Dosage Form : Tablet
Grade : Not Available
Application : Direct Compression
Excipient Details : Ready-to-use direct compression solution for tablets.
Dosage Form : Tablet
Grade : Not Available
Application : Direct Compression
Excipient Details : Ready-to-use direct compression solution for lozenges, chewables and effervescent tablets.
Pharmacopoeia Ref : Ph. Eur., USP/NF and J.P
Technical Specs : Not Available
Ingredient(s) : Povidone
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Excipients by Applications
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Trimagnesium Dicitrate 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 Trimagnesium Dicitrate manufacturer or Trimagnesium Dicitrate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Trimagnesium Dicitrate manufacturer or Trimagnesium Dicitrate supplier.
A Magnesium Citrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Magnesium Citrate, including repackagers and relabelers. The FDA regulates Magnesium Citrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Magnesium Citrate 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 Magnesium Citrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Magnesium Citrate supplier is an individual or a company that provides Magnesium Citrate active pharmaceutical ingredient (API) or Magnesium Citrate finished formulations upon request. The Magnesium Citrate suppliers may include Magnesium Citrate API manufacturers, exporters, distributors and traders.
click here to find a list of Magnesium Citrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Magnesium Citrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Magnesium Citrate active pharmaceutical ingredient (API) in detail. Different forms of Magnesium Citrate DMFs exist exist since differing nations have different regulations, such as Magnesium Citrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Magnesium Citrate DMF submitted to regulatory agencies in the US is known as a USDMF. Magnesium Citrate USDMF includes data on Magnesium Citrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Magnesium Citrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Magnesium Citrate suppliers with USDMF on PharmaCompass.
A Magnesium Citrate CEP of the European Pharmacopoeia monograph is often referred to as a Magnesium Citrate Certificate of Suitability (COS). The purpose of a Magnesium Citrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Magnesium Citrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Magnesium Citrate to their clients by showing that a Magnesium Citrate CEP has been issued for it. The manufacturer submits a Magnesium Citrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Magnesium Citrate CEP holder for the record. Additionally, the data presented in the Magnesium Citrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Magnesium Citrate DMF.
A Magnesium Citrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Magnesium Citrate 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 Magnesium Citrate suppliers with CEP (COS) on PharmaCompass.
A Magnesium Citrate written confirmation (Magnesium Citrate WC) is an official document issued by a regulatory agency to a Magnesium Citrate manufacturer, verifying that the manufacturing facility of a Magnesium Citrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Magnesium Citrate APIs or Magnesium Citrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Magnesium Citrate WC (written confirmation) as part of the regulatory process.
click here to find a list of Magnesium Citrate 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 Magnesium Citrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Magnesium Citrate 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 Magnesium Citrate 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 Magnesium Citrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Magnesium Citrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Magnesium Citrate suppliers with NDC on PharmaCompass.
Magnesium Citrate 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 Magnesium Citrate GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Magnesium Citrate GMP manufacturer or Magnesium Citrate GMP API supplier for your needs.
A Magnesium Citrate CoA (Certificate of Analysis) is a formal document that attests to Magnesium Citrate's compliance with Magnesium Citrate specifications and serves as a tool for batch-level quality control.
Magnesium Citrate CoA mostly includes findings from lab analyses of a specific batch. For each Magnesium Citrate 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.
Magnesium Citrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Magnesium Citrate EP), Magnesium Citrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Magnesium Citrate USP).