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1. Temaril
2. Theralen
3. Theraline
4. Trimeprazine Tartrate
1. Trimeprazine Tartrate
2. 4330-99-8
3. Trimeprazine Hemitartrate Salt
4. Nsc-17475
5. Nsc-757358
6. Prestwick_144
7. Chembl3989885
8. Hms1570j05
9. Hms3714j05
10. Trimeprazine Hemi-(+)-tartrate Salt
11. Ccg-220842
Molecular Weight | 747.0 g/mol |
---|---|
Molecular Formula | C40H50N4O6S2 |
Hydrogen Bond Donor Count | 4 |
Hydrogen Bond Acceptor Count | 12 |
Rotatable Bond Count | 11 |
Exact Mass | 746.31717767 g/mol |
Monoisotopic Mass | 746.31717767 g/mol |
Topological Polar Surface Area | 179 Ų |
Heavy Atom Count | 52 |
Formal Charge | 0 |
Complexity | 445 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 4 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 3 |
Histamine H1 Antagonists
Drugs that selectively bind to but do not activate histamine H1 receptors, thereby blocking the actions of endogenous histamine. Included here are the classical antihistaminics that antagonize or prevent the action of histamine mainly in immediate hypersensitivity. They act in the bronchi, capillaries, and some other smooth muscles, and are used to prevent or allay motion sickness, seasonal rhinitis, and allergic dermatitis and to induce somnolence. The effects of blocking central nervous system H1 receptors are not as well understood. (See all compounds classified as Histamine H1 Antagonists.)
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5947
Submission : 1985-08-06
Status : Inactive
Type : II
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15817
Submission : 2002-01-17
Status : Active
Type : II
Certificate Number : R1-CEP 2015-165 - Rev 00
Issue Date : 2021-06-08
Type : Chemical
Substance Number : 2650
Status : Valid
Registration Number : 218MF10151
Registrant's Address : 23, rue Bossuet Z. I. de la Vigne aux Loups F-91160 LONGJUMEAU France
Initial Date of Registration : 2006-01-31
Latest Date of Registration :
NDC Package Code : 49169-1029
Start Marketing Date : 2010-07-07
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : ASMF |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2668
Submission : 1976-05-04
Status : Inactive
Type : II
NDC Package Code : 51916-339
Start Marketing Date : 2016-03-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (100g/100g)
Marketing Category : BULK INGREDIENT
Certificate Number : CEP 2022-401 - Rev 00
Issue Date : 2024-10-17
Type : Chemical
Substance Number : 2650
Status : Valid
NDC Package Code : 71554-117
Start Marketing Date : 2020-05-25
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
VMF Number : 6464
Submission : 2022-02-17
Status : Active
Type : II
NDC Package Code : 52952-002
Start Marketing Date : 2016-12-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
VMF Number : 6199
Submission : 2017-07-27
Status : Active
Type : II
NDC Package Code : 51927-0166
Start Marketing Date : 2020-07-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
NDC Package Code : 71052-088
Start Marketing Date : 2021-02-19
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5947
Submission : 1985-08-06
Status : Inactive
Type : II
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15817
Submission : 2002-01-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2668
Submission : 1976-05-04
Status : Inactive
Type : II
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
Certificate Number : R1-CEP 2015-165 - Rev 00
Status : Valid
Issue Date : 2021-06-08
Type : Chemical
Substance Number : 2650
Certificate Number : CEP 2022-401 - Rev 00
Status : Valid
Issue Date : 2024-10-17
Type : Chemical
Substance Number : 2650
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
NDC Package Code : 49169-1029
Start Marketing Date : 2010-07-07
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 71052-088
Start Marketing Date : 2021-02-19
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 52952-002
Start Marketing Date : 2016-12-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 51916-339
Start Marketing Date : 2016-03-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (100g/100g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 51927-0166
Start Marketing Date : 2020-07-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 71554-117
Start Marketing Date : 2020-05-25
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
About the Company : EUROAPI is focused on reinventing active ingredient solutions to meet the needs of customers and patients worldwide sustainably. We are a leading player in APIs with approximately ...
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
About the Company : Since its inception in 2003, Seqens has evolved into a global leader in pharmaceutical solutions and specialty ingredients. With a strong focus on customer support, Seqens assists ...
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About the Company : Fuan Pharmaceutical (Group) Co., Ltd. was established on February 25, 2004. The company is located in Chongqing Changshou Economic and Technological Development Zone, covering an a...
About the Company : Established in 1995, Globalchem India was founded with the mission of catering to the global community. Since its inception, our primary focus has been to supply pharmaceutical ing...
About the Company : JRS Pharma is well known and valued - the most successful system partner for tabletting excipients and services, driving the pharmaceutical world with innovative excipients designe...
About the Company : Established in 1984, R L Fine Chem Pvt. Ltd. is one of the fastest growing API companies, with a leadership position in several APIs such as antihistamines, antidepressants and mus...
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Details:
Through the acquisition, Rosemont will expand its existing portfolio and have access to a pipeline of innovative products including, alimemazine tartrate, an oral solution, used for the management of urticaria and pruritus.
Lead Product(s): Alimemazine
Therapeutic Area: Dermatology Brand Name: Alimemazine Tartrate-Generic
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Rosemont
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition June 16, 2023
Lead Product(s) : Alimemazine
Therapeutic Area : Dermatology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Rosemont
Deal Size : Undisclosed
Deal Type : Acquisition
Rosemont Expands its Offering with Portfolio Acquisition from Lucis Pharma Ltd
Details : Through the acquisition, Rosemont will expand its existing portfolio and have access to a pipeline of innovative products including, alimemazine tartrate, an oral solution, used for the management of urticaria and pruritus.
Product Name : Alimemazine Tartrate-Generic
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
June 16, 2023
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Sweden
Brand Name : Theralen
Dosage Form : ORAL DROPS, SOLUTION
Dosage Strength : 40 MG / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Sweden
Brand Name : Theralen
Dosage Form : FILM COATED PILL
Dosage Strength : 5 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Vallergan Forte
Dosage Form : SYR
Dosage Strength : 30mg/5ml
Packaging : 100X1mg/5ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : DISCN
Registration Country : USA
Brand Name : TEMARIL
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 2.5MG BASE
Packaging :
Approval Date : 1982-01-01
Application Number : 11316
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : TEMARIL
Dosage Form : SYRUP;ORAL
Dosage Strength : EQ 2.5MG BASE/5ML
Packaging :
Approval Date : 1982-01-01
Application Number : 11316
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : TEMARIL
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : EQ 5MG BASE
Packaging :
Approval Date : 1982-01-01
Application Number : 11316
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info :
Registration Country : India
Brand Name : Alimemazine Tartrate
Dosage Form : Tablet
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info :
Registration Country : Norway
Brand Name : Alimemazin Evolan
Dosage Form : Dr?per, oppl?sning
Dosage Strength : 40 mg/ml
Packaging : Glass bottle 50ml
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info : DISCN
Registration Country : USA
Brand Name : TRIMEPRAZINE TARTRATE
Dosage Form : SYRUP;ORAL
Dosage Strength : EQ 2.5MG BASE/5ML
Packaging :
Approval Date : 1985-04-11
Application Number : 88285
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info :
Registration Country : Norway
Brand Name : Alimemazin Orifarm
Dosage Form : Dr?per, oppl?sning
Dosage Strength : 40 mg/ml
Packaging : Glass bottle 50ml
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Global Sales Information
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Alimemazine 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 Alimemazine manufacturer or Alimemazine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Alimemazine manufacturer or Alimemazine supplier.
PharmaCompass also assists you with knowing the Alimemazine API Price utilized in the formulation of products. Alimemazine API Price is not always fixed or binding as the Alimemazine Price is obtained through a variety of data sources. The Alimemazine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Alimemazine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alimemazine, including repackagers and relabelers. The FDA regulates Alimemazine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alimemazine 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 Alimemazine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Alimemazine supplier is an individual or a company that provides Alimemazine active pharmaceutical ingredient (API) or Alimemazine finished formulations upon request. The Alimemazine suppliers may include Alimemazine API manufacturers, exporters, distributors and traders.
click here to find a list of Alimemazine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Alimemazine DMF (Drug Master File) is a document detailing the whole manufacturing process of Alimemazine active pharmaceutical ingredient (API) in detail. Different forms of Alimemazine DMFs exist exist since differing nations have different regulations, such as Alimemazine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Alimemazine DMF submitted to regulatory agencies in the US is known as a USDMF. Alimemazine USDMF includes data on Alimemazine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Alimemazine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Alimemazine 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 Alimemazine Drug Master File in Japan (Alimemazine JDMF) empowers Alimemazine 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 Alimemazine JDMF during the approval evaluation for pharmaceutical products. At the time of Alimemazine 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 Alimemazine suppliers with JDMF on PharmaCompass.
A Alimemazine CEP of the European Pharmacopoeia monograph is often referred to as a Alimemazine Certificate of Suitability (COS). The purpose of a Alimemazine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Alimemazine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Alimemazine to their clients by showing that a Alimemazine CEP has been issued for it. The manufacturer submits a Alimemazine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Alimemazine CEP holder for the record. Additionally, the data presented in the Alimemazine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Alimemazine DMF.
A Alimemazine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Alimemazine 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 Alimemazine suppliers with CEP (COS) 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 Alimemazine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Alimemazine 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 Alimemazine 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 Alimemazine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Alimemazine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Alimemazine suppliers with NDC on PharmaCompass.
Alimemazine 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 Alimemazine 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 Alimemazine GMP manufacturer or Alimemazine GMP API supplier for your needs.
A Alimemazine CoA (Certificate of Analysis) is a formal document that attests to Alimemazine's compliance with Alimemazine specifications and serves as a tool for batch-level quality control.
Alimemazine CoA mostly includes findings from lab analyses of a specific batch. For each Alimemazine 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.
Alimemazine may be tested according to a variety of international standards, such as European Pharmacopoeia (Alimemazine EP), Alimemazine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Alimemazine USP).