Synopsis
Synopsis
0
CEP/COS
0
JDMF
0
EU WC
0
KDMF
0
NDC API
0
VMF
0
EDQM
0
USP
0
JP
0
Others
0
FDA Orange Book
0
Canada
0
Australia
0
South Africa
DRUG PRODUCT COMPOSITIONS
0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
1. Amox Clav
2. Amox-clav
3. Amoxi Clavulanate
4. Amoxi-clavulanate
5. Amoxicillin Clavulanic Acid
6. Amoxicillin Potassium Clavulanate Combination
7. Amoxicillin-clavulanic Acid
8. Amoxicillin-potassium Clavulanate Combination
9. Amoxycillin Clavulanic Acid
10. Amoxycillin, Clavulanate Potentiated
11. Amoxycillin-clavulanic Acid
12. Augmentin
13. Brl 25000
14. Brl-25000
15. Brl25000
16. Clavulanate Potentiated Amoxycillin
17. Clavulin
18. Co Amoxiclav
19. Co-amoxiclav
20. Coamoxiclav
21. Potassium Clavulanate Amoxicillin Combination
22. Potassium Clavulanate-amoxicillin Combination
23. Spektramox
24. Synulox
1. Co-amoxiclav
2. 74469-00-4
3. Amoxicillin Clavulanate Potassium
4. Amoxicillin Mixture With Clavulanate Potassium
5. Amoclan
6. Amoclav
7. Amoxsiklav
8. Augmentan
9. Augmentine
10. Auspilic
11. Clamentin
12. Clamobit
13. Clavinex
14. Clavumox
15. Eumetinex
16. Kmoxilin
17. Spectramox
18. Viaclav
19. Amocla
20. Xiclav
21. Ancla
22. Clavoxilin Plus
23. 4-oxa-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 3-(2-hydroxyethylidene)-7-oxo-, Monopotassium Salt, (2r-(2-alpha,3z,5-alpha))-, Mixt. With (2s-(2-alpha,5-alpha,6-beta(s*)))-6-((amino(4-hydroxyphenyl)acetyl)amino)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid (1:2)
24. Augmentin Es-600
25. Brl 25000
26. Augmentin (antibiotic)
27. Augmentin Xr
28. Augmentin '125'
29. Augmentin '200'
30. Augmentin '250'
31. Augmentin '400'
32. Augmentin '500'
33. Augmentin '875'
34. Clavam 625
35. Brl 25000a
36. Brl 25000g
37. Amoxicillin Mixed With Potassium Clavulanate (2:1)
38. Potassium Clavulanate Mixed With Amoxicillin (1:2)
39. Amoxicillin / Clavulanic Acid
40. Schembl240728
41. Chembl1697738
42. Dtxsid40225477
43. Amoxicillin/clavulanic Acid
44. Amoxicillin-clavulanate (potassium)
45. 4-oxa-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 3-(2-hydroxyethylidene)-7-oxo-, Monopotassium Salt, (2r,3z,5r)-, Mixt. With (2s,5r,6r)-6-(((2r)-amino(4-hydroxyphenyl)acetyl)amino)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid
46. Hy-135532
47. Q2870929
48. Potassium;(2s,5r,6r)-6-[[(2r)-2-amino-2-(4-hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid;(2r,3z,5r)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate
Molecular Weight | 602.7 g/mol |
---|---|
Molecular Formula | C24H27KN4O10S |
Hydrogen Bond Donor Count | 5 |
Hydrogen Bond Acceptor Count | 12 |
Rotatable Bond Count | 6 |
Exact Mass | 602.10849573 g/mol |
Monoisotopic Mass | 602.10849573 g/mol |
Topological Polar Surface Area | 248 Ų |
Heavy Atom Count | 40 |
Formal Charge | 0 |
Complexity | 919 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 6 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 1 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 3 |
1 of 18 | |
---|---|
Drug Name | Amoxicillin and clavulanate potassium |
PubMed Health | Amoxicillin/Clavulanate Potassium (By mouth) |
Drug Classes | Antibiotic |
Drug Label | AUGMENTIN is an oral antibacterial combination consisting of the semisynthetic antibiotic amoxicillin and the -lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived fro... |
Active Ingredient | clavulanate potassium; Amoxicillin |
Dosage Form | Tablet, extended release; Tablet; Tablet, chewable; For suspension; Suspension |
Route | Oral |
Strength | 600mg/5ml; eq 62.5mg base; 875mg; eq 57mg base; eq 28.5mg base/5ml; 200mg/5ml; 200mg; 250mg; eq 125mg base; eq 28.5mg base; eq 62.5mg base/5ml; 400mg/5ml; 1gm; eq 57mg base/5ml; eq 42.9mg base/5ml; 500mg; 250mg/5ml; 400mg |
Market Status | Prescription |
Company | Wockhardt; Ranbaxy; Teva; Aurobindo Pharma; Teva Pharms Usa; Wockhardt Eu Operatn; Sandoz; Hikma Pharms |
2 of 18 | |
---|---|
Drug Name | Augmentin '125' |
Active Ingredient | clavulanate potassium; Amoxicillin |
Dosage Form | Tablet, chewable; For suspension |
Route | Oral |
Strength | 125mg/5ml; eq 31.25mg base; 125mg; eq 31.25mg base/5ml |
Market Status | Prescription |
Company | Dr Reddys Labs |
3 of 18 | |
---|---|
Drug Name | Augmentin '200' |
Active Ingredient | clavulanate potassium; Amoxicillin |
Dosage Form | Tablet, chewable; For suspension |
Route | Oral |
Strength | 200mg; eq 28.5mg base/5ml; 200mg/5ml; eq 28.5mg base |
Market Status | Prescription |
Company | Dr Reddys Labs |
4 of 18 | |
---|---|
Drug Name | Augmentin '250' |
Active Ingredient | clavulanate potassium; Amoxicillin |
Dosage Form | Tablet; Tablet, chewable; For suspension |
Route | Oral |
Strength | eq 62.5mg base; 250mg; eq 125mg base; eq 62.5mg base/5ml; 250mg/5ml |
Market Status | Prescription |
Company | Dr Reddys Labs |
5 of 18 | |
---|---|
Drug Name | Augmentin '400' |
Active Ingredient | clavulanate potassium; Amoxicillin |
Dosage Form | Tablet, chewable; For suspension |
Route | Oral |
Strength | eq 57mg base; 400mg/5ml; eq 57mg base/5ml; 400mg |
Market Status | Prescription |
Company | Dr Reddys Labs |
6 of 18 | |
---|---|
Drug Name | Augmentin '500' |
Active Ingredient | clavulanate potassium; Amoxicillin |
Dosage Form | Tablet |
Route | Oral |
Strength | eq 125mg base; 500mg |
Market Status | Prescription |
Company | Dr Reddys Labs |
7 of 18 | |
---|---|
Drug Name | Augmentin '875' |
Active Ingredient | clavulanate potassium; Amoxicillin |
Dosage Form | Tablet |
Route | Oral |
Strength | 875mg; eq 125mg base |
Market Status | Prescription |
Company | Dr Reddys Labs |
8 of 18 | |
---|---|
Drug Name | Augmentin es-600 |
Active Ingredient | clavulanate potassium; Amoxicillin |
Dosage Form | For suspension |
Route | Oral |
Strength | 600mg/5ml; eq 42.9mg base/5ml |
Market Status | Prescription |
Company | Dr Reddys Labs |
9 of 18 | |
---|---|
Drug Name | Augmentin xr |
Active Ingredient | clavulanate potassium; Amoxicillin |
Dosage Form | Tablet, extended release |
Route | Oral |
Strength | eq 62.5mg base; 1gm |
Market Status | Prescription |
Company | Dr Reddys Labs |
10 of 18 | |
---|---|
Drug Name | Amoxicillin and clavulanate potassium |
PubMed Health | Amoxicillin/Clavulanate Potassium (By mouth) |
Drug Classes | Antibiotic |
Drug Label | AUGMENTIN is an oral antibacterial combination consisting of the semisynthetic antibiotic amoxicillin and the -lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived fro... |
Active Ingredient | clavulanate potassium; Amoxicillin |
Dosage Form | Tablet, extended release; Tablet; Tablet, chewable; For suspension; Suspension |
Route | Oral |
Strength | 600mg/5ml; eq 62.5mg base; 875mg; eq 57mg base; eq 28.5mg base/5ml; 200mg/5ml; 200mg; 250mg; eq 125mg base; eq 28.5mg base; eq 62.5mg base/5ml; 400mg/5ml; 1gm; eq 57mg base/5ml; eq 42.9mg base/5ml; 500mg; 250mg/5ml; 400mg |
Market Status | Prescription |
Company | Wockhardt; Ranbaxy; Teva; Aurobindo Pharma; Teva Pharms Usa; Wockhardt Eu Operatn; Sandoz; Hikma Pharms |
11 of 18 | |
---|---|
Drug Name | Augmentin '125' |
Active Ingredient | clavulanate potassium; Amoxicillin |
Dosage Form | Tablet, chewable; For suspension |
Route | Oral |
Strength | 125mg/5ml; eq 31.25mg base; 125mg; eq 31.25mg base/5ml |
Market Status | Prescription |
Company | Dr Reddys Labs |
12 of 18 | |
---|---|
Drug Name | Augmentin '200' |
Active Ingredient | clavulanate potassium; Amoxicillin |
Dosage Form | Tablet, chewable; For suspension |
Route | Oral |
Strength | 200mg; eq 28.5mg base/5ml; 200mg/5ml; eq 28.5mg base |
Market Status | Prescription |
Company | Dr Reddys Labs |
13 of 18 | |
---|---|
Drug Name | Augmentin '250' |
Active Ingredient | clavulanate potassium; Amoxicillin |
Dosage Form | Tablet; Tablet, chewable; For suspension |
Route | Oral |
Strength | eq 62.5mg base; 250mg; eq 125mg base; eq 62.5mg base/5ml; 250mg/5ml |
Market Status | Prescription |
Company | Dr Reddys Labs |
14 of 18 | |
---|---|
Drug Name | Augmentin '400' |
Active Ingredient | clavulanate potassium; Amoxicillin |
Dosage Form | Tablet, chewable; For suspension |
Route | Oral |
Strength | eq 57mg base; 400mg/5ml; eq 57mg base/5ml; 400mg |
Market Status | Prescription |
Company | Dr Reddys Labs |
15 of 18 | |
---|---|
Drug Name | Augmentin '500' |
Active Ingredient | clavulanate potassium; Amoxicillin |
Dosage Form | Tablet |
Route | Oral |
Strength | eq 125mg base; 500mg |
Market Status | Prescription |
Company | Dr Reddys Labs |
16 of 18 | |
---|---|
Drug Name | Augmentin '875' |
Active Ingredient | clavulanate potassium; Amoxicillin |
Dosage Form | Tablet |
Route | Oral |
Strength | 875mg; eq 125mg base |
Market Status | Prescription |
Company | Dr Reddys Labs |
17 of 18 | |
---|---|
Drug Name | Augmentin es-600 |
Active Ingredient | clavulanate potassium; Amoxicillin |
Dosage Form | For suspension |
Route | Oral |
Strength | 600mg/5ml; eq 42.9mg base/5ml |
Market Status | Prescription |
Company | Dr Reddys Labs |
18 of 18 | |
---|---|
Drug Name | Augmentin xr |
Active Ingredient | clavulanate potassium; Amoxicillin |
Dosage Form | Tablet, extended release |
Route | Oral |
Strength | eq 62.5mg base; 1gm |
Market Status | Prescription |
Company | Dr Reddys Labs |
Anti-Bacterial Agents
Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)
beta-Lactamase Inhibitors
Endogenous substances and drugs that inhibit or block the activity of BETA-LACTAMASES. (See all compounds classified as beta-Lactamase Inhibitors.)
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26966
Submission : 2013-01-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26966
Submission : 2013-01-29
Status : Active
Type : II
About the Company : Sandoz B2B provides access to an extensive portfolio of high-quality products and services, covering more than 20 therapeutic areas. Delivering unique added value to our partners w...
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
---|
Upgrade, download data, analyse, strategize, subscribe with us
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Regulatory Info :
Registration Country : Netherlands
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 500MG; 125MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Netherlands
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Packaging :
Regulatory Info :
Dosage : Film Coated Tablet
Dosage Strength : 500MG; 125MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Netherlands
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Regulatory Info :
Registration Country : Netherlands
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 875MG; 125MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Netherlands
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Packaging :
Regulatory Info :
Dosage : Film Coated Tablet
Dosage Strength : 875MG; 125MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Netherlands
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Regulatory Info :
Registration Country : Netherlands
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 500MG; 62.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Netherlands
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Packaging :
Regulatory Info :
Dosage : Film Coated Tablet
Dosage Strength : 500MG; 62.5MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Netherlands
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Regulatory Info :
Registration Country : Netherlands
Brand Name :
Dosage Form : Powder for Oral Suspen...
Dosage Strength : 125MG/5ML; 31.25MG/5ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Netherlands
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Packaging :
Regulatory Info :
Dosage : Powder for Oral Suspen...
Dosage Strength : 125MG/5ML; 31.25MG/5ML
Brand Name :
Approval Date :
Application Number :
Registration Country : Netherlands
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Regulatory Info :
Registration Country : Netherlands
Brand Name :
Dosage Form : Powder for Oral Suspen...
Dosage Strength : 250MG/5ML; 62.5MG/5ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Netherlands
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Packaging :
Regulatory Info :
Dosage : Powder for Oral Suspen...
Dosage Strength : 250MG/5ML; 62.5MG/5ML
Brand Name :
Approval Date :
Application Number :
Registration Country : Netherlands
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Regulatory Info :
Registration Country : Netherlands
Brand Name :
Dosage Form : Powder for Oral Suspen...
Dosage Strength : 400MG/5ML; 57MG/5ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Netherlands
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Packaging :
Regulatory Info :
Dosage : Powder for Oral Suspen...
Dosage Strength : 400MG/5ML; 57MG/5ML
Brand Name :
Approval Date :
Application Number :
Registration Country : Netherlands
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Regulatory Info :
Registration Country : Netherlands
Brand Name :
Dosage Form : Powder for Oral Suspen...
Dosage Strength : 600MG/5ML; 42.9MG/5ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Netherlands
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Packaging :
Regulatory Info :
Dosage : Powder for Oral Suspen...
Dosage Strength : 600MG/5ML; 42.9MG/5ML
Brand Name :
Approval Date :
Application Number :
Registration Country : Netherlands
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Regulatory Info :
Registration Country : Netherlands
Brand Name :
Dosage Form : Powder for Oral Suspen...
Dosage Strength : 500MG/5ML; 62.5MG/5ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Netherlands
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Packaging :
Regulatory Info :
Dosage : Powder for Oral Suspen...
Dosage Strength : 500MG/5ML; 62.5MG/5ML
Brand Name :
Approval Date :
Application Number :
Registration Country : Netherlands
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Regulatory Info :
Registration Country : Netherlands
Brand Name :
Dosage Form : Powder for Oral Suspen...
Dosage Strength : 500MG; 125MG
Packaging : Sachet
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Netherlands
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Packaging : Sachet
Regulatory Info :
Dosage : Powder for Oral Suspen...
Dosage Strength : 500MG; 125MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Netherlands
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Regulatory Info :
Registration Country : Netherlands
Brand Name :
Dosage Form : Powder for Oral Suspen...
Dosage Strength : 875MG; 125MG
Packaging : Sachet
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Netherlands
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Packaging : Sachet
Regulatory Info :
Dosage : Powder for Oral Suspen...
Dosage Strength : 875MG; 125MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Netherlands
Global Sales Information
Market Place
Reply
11 Apr 2023
Reply
02 Jan 2023
Reply
25 Jan 2022
Reply
26 Jul 2021
Reply
15 Sep 2020
Reply
10 Jul 2018
ABOUT THIS PAGE
82
PharmaCompass offers a list of Co-amoxiclav 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 Co-amoxiclav manufacturer or Co-amoxiclav supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Co-amoxiclav manufacturer or Co-amoxiclav supplier.
PharmaCompass also assists you with knowing the Co-amoxiclav API Price utilized in the formulation of products. Co-amoxiclav API Price is not always fixed or binding as the Co-amoxiclav Price is obtained through a variety of data sources. The Co-amoxiclav Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Amocla manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amocla, including repackagers and relabelers. The FDA regulates Amocla manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amocla 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 Amocla manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Amocla supplier is an individual or a company that provides Amocla active pharmaceutical ingredient (API) or Amocla finished formulations upon request. The Amocla suppliers may include Amocla API manufacturers, exporters, distributors and traders.
click here to find a list of Amocla suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Amocla DMF (Drug Master File) is a document detailing the whole manufacturing process of Amocla active pharmaceutical ingredient (API) in detail. Different forms of Amocla DMFs exist exist since differing nations have different regulations, such as Amocla USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Amocla DMF submitted to regulatory agencies in the US is known as a USDMF. Amocla USDMF includes data on Amocla's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Amocla USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Amocla suppliers with USDMF on PharmaCompass.
Amocla 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 Amocla 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 Amocla GMP manufacturer or Amocla GMP API supplier for your needs.
A Amocla CoA (Certificate of Analysis) is a formal document that attests to Amocla's compliance with Amocla specifications and serves as a tool for batch-level quality control.
Amocla CoA mostly includes findings from lab analyses of a specific batch. For each Amocla 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.
Amocla may be tested according to a variety of international standards, such as European Pharmacopoeia (Amocla EP), Amocla JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Amocla USP).