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1. Hexamine Hippurate
2. Hip-rex
3. Hiprex
4. Urex
5. Urotractan
1. 5714-73-8
2. Hiprex
3. Hexamine Hippurate
4. Hexamethylenetetramine Monohippurate
5. Hexamethylenetetramine Hippurate
6. 1,3,5,7-tetraazaadamantane Benzoylglycinate
7. Methenamine (hippurate)
8. Hippramine
9. Haiprex
10. Viapta
11. 2-benzamidoacetic Acid;1,3,5,7-tetrazatricyclo[3.3.1.13,7]decane
12. M329791l57
13. Glycine, N-benzoyl, Compd. With 1,3,5,7-tetraazatricyclo(3.3.1.1(sup 3,7))decane (1:1)
14. Hexamethylenetetramine Monohippurate;hexamethylenetetramine Monohippurate
15. Methenamine Hippurate [usan]
16. R-657
17. Einecs 227-206-5
18. Hexamethylene Tetramine Hippurate
19. Unii-m329791l57
20. Hiprex (tn)
21. Urex (tn)
22. Hippuric Acid, Compd. With Hexamethylenetetramine (1:1)
23. Methenamine Hippurate [usan:usp:inn:ban]
24. Schembl3029
25. Chebi:6825
26. Chembl1201104
27. Dtxsid10972603
28. Methenamine Hippurate (jan/usp)
29. Methenamine Hippurate [jan]
30. Hy-b1691
31. Methenamine Hippurate [vandf]
32. Mfcd00072147
33. S9466
34. Methenamine Hippurate [mart.]
35. Akos037645132
36. Methenamine Hippurate [usp-rs]
37. Methenamine Hippurate [who-dd]
38. N-benzoylglycine, Compound With 1,3,5,7-tetraazatricyclo(3.3.1.13,7)decane (1:1)
39. Methenamine Hippurate (200 Mg)
40. As-57463
41. Methenamine Hippurate [orange Book]
42. Methenamine Hippurate [usp Impurity]
43. Cs-0013675
44. Ft-0671059
45. Methenamine Hippurate [usp Monograph]
46. D00855
47. D81437
48. 714m738
49. Q27283414
50. 1,3,5,7-tetraazatricyclo[3.3.1.1(3),?]decane; 2-(phenylformamido)acetic Acid
51. N-[hydroxy(phenyl)methylidene]glycine--1,3,5,7-tetraazatricyclo[3.3.1.1~3,7~]decane (1/1)
Molecular Weight | 319.36 g/mol |
---|---|
Molecular Formula | C15H21N5O3 |
Hydrogen Bond Donor Count | 2 |
Hydrogen Bond Acceptor Count | 7 |
Rotatable Bond Count | 3 |
Exact Mass | 319.16443955 g/mol |
Monoisotopic Mass | 319.16443955 g/mol |
Topological Polar Surface Area | 79.4 Ų |
Heavy Atom Count | 23 |
Formal Charge | 0 |
Complexity | 282 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
1 of 4 | |
---|---|
Drug Name | Hiprex |
Drug Label | Each yellow capsule-shaped tablet contains 1 g Methenamine Hippurate which is the Hippuric Acid Salt of Methenamine (hexamethylene tetramine). The tablet also contains inactive ingredients. FD&C Yellow No. 5 (tartrazine, see PRECAUTIONS), Magnesium S. |
Active Ingredient | Methenamine hippurate |
Dosage Form | Tablet |
Route | Oral |
Strength | 1gm |
Market Status | Prescription |
Company | Sanofi Aventis Us |
2 of 4 | |
---|---|
Drug Name | Methenamine hippurate |
PubMed Health | Methenamine (By mouth) |
Drug Classes | Antiseptic |
Drug Label | Methenamine Hippurate Tablets are a urinary tract antiseptic drug. Each white, scored tablet contains methenamine hippurate 1g (see HOW SUPPLIED). Methenamine Hippurate Tablets also contain: magnesium stearate, povidone and saccharin sodium. Chemical... |
Active Ingredient | Methenamine hippurate |
Dosage Form | Tablet |
Route | Oral |
Strength | 1gm |
Market Status | Prescription |
Company | Corepharma |
3 of 4 | |
---|---|
Drug Name | Hiprex |
Drug Label | Each yellow capsule-shaped tablet contains 1 g Methenamine Hippurate which is the Hippuric Acid Salt of Methenamine (hexamethylene tetramine). The tablet also contains inactive ingredients. FD&C Yellow No. 5 (tartrazine, see PRECAUTIONS), Magnesium S. |
Active Ingredient | Methenamine hippurate |
Dosage Form | Tablet |
Route | Oral |
Strength | 1gm |
Market Status | Prescription |
Company | Sanofi Aventis Us |
4 of 4 | |
---|---|
Drug Name | Methenamine hippurate |
PubMed Health | Methenamine (By mouth) |
Drug Classes | Antiseptic |
Drug Label | Methenamine Hippurate Tablets are a urinary tract antiseptic drug. Each white, scored tablet contains methenamine hippurate 1g (see HOW SUPPLIED). Methenamine Hippurate Tablets also contain: magnesium stearate, povidone and saccharin sodium. Chemical... |
Active Ingredient | Methenamine hippurate |
Dosage Form | Tablet |
Route | Oral |
Strength | 1gm |
Market Status | Prescription |
Company | Corepharma |
Anti-Bacterial Agents
Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)
Anti-Infective Agents, Urinary
Substances capable of killing agents causing urinary tract infections or of preventing them from spreading. (See all compounds classified as Anti-Infective Agents, Urinary.)
Laboratorium Ofichem, offering a flexible, high-tech environment to produce broad range of APIs for Human & Vet pharmaceutical markets.
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-07-23
Pay. Date : 2024-07-08
DMF Number : 40057
Submission : 2024-07-04
Status : Active
Type : II
NDC Package Code : 58159-105
Start Marketing Date : 2024-10-08
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (35kg/35kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-10-27
Pay. Date : 2014-03-28
DMF Number : 28120
Submission : 2014-04-04
Status : Active
Type : II
NDC Package Code : 65319-1098
Start Marketing Date : 2019-06-21
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-07-08
Pay. Date : 2013-04-15
DMF Number : 27021
Submission : 2013-04-09
Status : Active
Type : II
NDC Package Code : 65862-808
Start Marketing Date : 2023-12-05
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-11-24
Pay. Date : 2021-09-24
DMF Number : 34680
Submission : 2020-10-10
Status : Active
Type : II
Date of Issue : 2022-08-29
Valid Till : 2025-07-26
Written Confirmation Number : WC-0180
Address of the Firm :
NDC Package Code : 83221-004
Start Marketing Date : 2023-03-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-11-20
Pay. Date : 2017-10-16
DMF Number : 31988
Submission : 2017-10-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16801
Submission : 2003-08-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7333
Submission : 1988-02-08
Status : Active
Type : II
NDC Package Code : 81066-0001
Start Marketing Date : 2021-11-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29058
Submission : 2015-05-13
Status : Inactive
Type : II
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
GDUFA
DMF Review : Complete
Rev. Date : 2024-07-23
Pay. Date : 2024-07-08
DMF Number : 40057
Submission : 2024-07-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-10-27
Pay. Date : 2014-03-28
DMF Number : 28120
Submission : 2014-04-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7100
Submission : 1987-08-04
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-08
Pay. Date : 2013-04-15
DMF Number : 27021
Submission : 2013-04-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16801
Submission : 2003-08-08
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-11-20
Pay. Date : 2017-10-16
DMF Number : 31988
Submission : 2017-10-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29058
Submission : 2015-05-13
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7333
Submission : 1988-02-08
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5018
Submission : 1983-07-29
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
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Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4949
Submission : 1983-05-23
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
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Website
Corporate PDF
Laboratorium Ofichem, offering a flexible, high-tech environment to produce broad range of APIs for Human & Vet pharmaceutical markets.
About the Company : Laboratorium Ofichem is a GMP-certified and FDA-approved API manufacturer with state-of-the-art development and production facilities in the Netherlands. We develop and manufacture...
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
About the Company : Established in 2012, Nuray Chemicals Pvt Ltd is an API manufacturer for highly regulated markets. Its manufacturing facility with state-of-the-art R&D is located near Chennai in th...
About the Company : Since its founding in 1962, MOEHS has produced Active Pharmaceutical Ingredients (APIs) for the international pharmaceutical industry. Thanks to a business history of more than 50 ...
About the Company : Kreative Organics Private Limited is a manufacturer of Active Pharmaceutical Ingredients (APIs) for the world market. Kreative started operations in 1990. Kreative was established ...
About the Company : Micro Labs Limited is a diversified healthcare company with cutting-edge R&D, advanced manufacturing facilities, and a strong distribution network. It ranks among India's top pharm...
About the Company : Recordati, established in 1926, is an international pharmaceutical group, listed on the Italian Stock Exchange (Reuters RECI.MI, Bloomberg REC IM, ISIN IT 0003828271), with a total...
About the Company : As an internationally renowned outsourcing partner, we offer products and tailor-made service packages that are seamlessly embedded in the value chain of our customers. Our pharmac...
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API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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Details:
Methenamine Hippurate tablets works by releasing formaldehyde in acidic urine, which denatures bacterial proteins and DNA, it is indicated for recurring urinary tract infections.
Lead Product(s): Methenamine Hippurate
Therapeutic Area: Infections and Infectious Diseases Brand Name: Hiprex-Generic
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 13, 2025
Lead Product(s) : Methenamine Hippurate
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Zydus Receives Final Approval from USFDA for Methenamine Hippurate Tablets USP, 1 Gram
Details : Methenamine Hippurate tablets works by releasing formaldehyde in acidic urine, which denatures bacterial proteins and DNA, it is indicated for recurring urinary tract infections.
Product Name : Hiprex-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 13, 2025
Regulatory Info :
Registration Country : Australia
Brand Name : Uramet
Dosage Form :
Dosage Strength :
Packaging : 100
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Uramet
Dosage Form :
Dosage Strength :
Packaging : 100
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info : RX
Registration Country : USA
Brand Name : METHENAMINE HIPPURATE
Dosage Form : TABLET;ORAL
Dosage Strength : 1GM
Packaging :
Approval Date : 2016-07-05
Application Number : 205661
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : HIPREX
Dosage Form : TABLET;ORAL
Dosage Strength : 1GM
Packaging :
Approval Date : 1982-01-01
Application Number : 17681
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Australia
Brand Name : Hiprex
Dosage Form :
Dosage Strength :
Packaging : 100
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Hiprex
Dosage Form :
Dosage Strength :
Packaging : 100
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info : RX
Registration Country : USA
Brand Name : METHENAMINE HIPPURATE
Dosage Form : TABLET;ORAL
Dosage Strength : 1GM
Packaging :
Approval Date : 2023-12-01
Application Number : 217675
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : METHENAMINE HIPPURATE
Dosage Form : TABLET;ORAL
Dosage Strength : 1GM
Packaging :
Approval Date : 2019-08-01
Application Number : 212172
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Sweden
Brand Name : Hiprex
Dosage Form : ORAL POWDER IN SACHET
Dosage Strength : 1 G
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Norway
Brand Name : Hiprex
Dosage Form : Antic-calc Tablet
Dosage Strength : 1 g
Packaging : Box
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Portfolio PDF
Product Web Link
Virtual Booth
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Corporate PDF
RLD : No
TE Code : AB
Brand Name : UREX
Dosage Form : TABLET;ORAL
Dosage Strength : 1GM
Approval Date : 1982-01-01
Application Number : 16151
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : METHENAMINE HIPPURATE
Dosage Form : TABLET;ORAL
Dosage Strength : 1GM
Approval Date : 2016-07-05
Application Number : 205661
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : Yes
TE Code : AB
Brand Name : HIPREX
Dosage Form : TABLET;ORAL
Dosage Strength : 1GM
Approval Date : 1982-01-01
Application Number : 17681
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
RLD : No
TE Code :
Brand Name : METHENAMINE HIPPURATE
Dosage Form : TABLET;ORAL
Dosage Strength : 1GM
Approval Date : 2003-06-20
Application Number : 76411
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code : AB
Brand Name : METHENAMINE HIPPURATE
Dosage Form : TABLET;ORAL
Dosage Strength : 1GM
Approval Date : 2023-12-01
Application Number : 217675
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : METHENAMINE HIPPURATE
Dosage Form : TABLET;ORAL
Dosage Strength : 1GM
Approval Date : 2019-08-01
Application Number : 212172
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : METHENAMINE HIPPURATE
Dosage Form : TABLET;ORAL
Dosage Strength : 1GM
Approval Date : 2020-11-27
Application Number : 210068
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : METHENAMINE HIPPURATE
Dosage Form : TABLET;ORAL
Dosage Strength : 1GM
Approval Date : 2025-03-10
Application Number : 219661
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
Regulatory Info :
Registration Country : Sweden
Brand Name : Hiprex
Dosage Form : ORAL POWDER IN SACHET
Dosage Strength : 1 G
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Sweden
Brand Name : Hiprex
Dosage Form : TABLET
Dosage Strength : 1 G
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Norway
Brand Name : Hiprex
Dosage Form : Antic-calc Tablet
Dosage Strength : 1 g
Packaging : Box
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Norway
Brand Name : Hiprex
Dosage Form : Antic-calc Tablet
Dosage Strength : 1 g
Packaging : Box
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Norway
Brand Name : Hiprex
Dosage Form : Powder in dose bag
Dosage Strength : 1 g
Packaging : Dose Bag
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Australia
Brand Name : Uramet
Dosage Form :
Dosage Strength :
Packaging : 100
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Uramet
Dosage Form :
Dosage Strength :
Packaging : 100
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Hiprex
Dosage Form :
Dosage Strength :
Packaging : 100
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Hiprex
Dosage Form :
Dosage Strength :
Packaging : 100
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Related Excipient Companies
Excipients by Applications
Dosage Form : Capsule, Tablet, Topical Film, Transdermal Patch
Grade : Not Available
Category : Controlled & Modified Release, Direct Compression, Granulation
Application : Controlled & Modified Release, Direct Compression, 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) : Lauryl Sulfate
Dosage Form : Capsule, Tablet, Transdermal Patch
Grade : Not Available
Category : Controlled & Modified Release
Application : Controlled & Modified Release
Excipient Details : Solubilization, dispersion, crystallization inhibition, instant release matrices & spray drying
Dosage Form : Capsule, Tablet, Transdermal Patch, Transdermal patches
Grade : Not Available
Category : Controlled & Modified Release, Solubilizers
Application : Controlled & Modified Release, 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
Global Sales Information
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ABOUT THIS PAGE
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PharmaCompass offers a list of Methenamine Hippurate 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 Methenamine Hippurate manufacturer or Methenamine Hippurate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Methenamine Hippurate manufacturer or Methenamine Hippurate supplier.
PharmaCompass also assists you with knowing the Methenamine Hippurate API Price utilized in the formulation of products. Methenamine Hippurate API Price is not always fixed or binding as the Methenamine Hippurate Price is obtained through a variety of data sources. The Methenamine Hippurate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Methenamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Methenamine, including repackagers and relabelers. The FDA regulates Methenamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Methenamine 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 Methenamine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Methenamine supplier is an individual or a company that provides Methenamine active pharmaceutical ingredient (API) or Methenamine finished formulations upon request. The Methenamine suppliers may include Methenamine API manufacturers, exporters, distributors and traders.
click here to find a list of Methenamine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Methenamine DMF (Drug Master File) is a document detailing the whole manufacturing process of Methenamine active pharmaceutical ingredient (API) in detail. Different forms of Methenamine DMFs exist exist since differing nations have different regulations, such as Methenamine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Methenamine DMF submitted to regulatory agencies in the US is known as a USDMF. Methenamine USDMF includes data on Methenamine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Methenamine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Methenamine suppliers with USDMF on PharmaCompass.
A Methenamine written confirmation (Methenamine WC) is an official document issued by a regulatory agency to a Methenamine manufacturer, verifying that the manufacturing facility of a Methenamine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Methenamine APIs or Methenamine finished pharmaceutical products to another nation, regulatory agencies frequently require a Methenamine WC (written confirmation) as part of the regulatory process.
click here to find a list of Methenamine 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 Methenamine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Methenamine 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 Methenamine 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 Methenamine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Methenamine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Methenamine suppliers with NDC on PharmaCompass.
Methenamine 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 Methenamine 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 Methenamine GMP manufacturer or Methenamine GMP API supplier for your needs.
A Methenamine CoA (Certificate of Analysis) is a formal document that attests to Methenamine's compliance with Methenamine specifications and serves as a tool for batch-level quality control.
Methenamine CoA mostly includes findings from lab analyses of a specific batch. For each Methenamine 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.
Methenamine may be tested according to a variety of international standards, such as European Pharmacopoeia (Methenamine EP), Methenamine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Methenamine USP).