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Also known as: 615-347-9, 7177-48-2, Aminobenzylpenicillin trihydrate, Penbritin, Nci-c56086, Ampicillin/ampicillin trihydrate
Molecular Formula
C16H25N3O7S
Molecular Weight
403.5  g/mol
InChI Key
RXDALBZNGVATNY-CWLIKTDRSA-N
FDA UNII
HXQ6A1N7R6

Ampicillin Trihydrate
Ampicillin Trihydrate is the trihydrate form of ampicillin, a broad-spectrum semisynthetic derivative of aminopenicillin. Ampicillin trihydrate inhibits bacterial cell wall synthesis by binding to penicillin binding proteins, thereby inhibiting peptidoglycan synthesis, a critical component of the bacterial cell wall.
1 2D Structure

Ampicillin Trihydrate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(2S,5R,6R)-6-[[(2R)-2-amino-2-phenylacetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid;trihydrate
2.1.2 InChI
InChI=1S/C16H19N3O4S.3H2O/c1-16(2)11(15(22)23)19-13(21)10(14(19)24-16)18-12(20)9(17)8-6-4-3-5-7-8;;;/h3-7,9-11,14H,17H2,1-2H3,(H,18,20)(H,22,23);3*1H2/t9-,10-,11+,14-;;;/m1.../s1
2.1.3 InChI Key
RXDALBZNGVATNY-CWLIKTDRSA-N
2.1.4 Canonical SMILES
CC1(C(N2C(S1)C(C2=O)NC(=O)C(C3=CC=CC=C3)N)C(=O)O)C.O.O.O
2.1.5 Isomeric SMILES
CC1([C@@H](N2[C@H](S1)[C@@H](C2=O)NC(=O)[C@@H](C3=CC=CC=C3)N)C(=O)O)C.O.O.O
2.2 Other Identifiers
2.2.1 UNII
HXQ6A1N7R6
2.3 Synonyms
2.3.1 Depositor-Supplied Synonyms

1. 615-347-9

2. 7177-48-2

3. Aminobenzylpenicillin Trihydrate

4. Penbritin

5. Nci-c56086

6. Ampicillin/ampicillin Trihydrate

7. Hxq6a1n7r6

8. (2s,5r,6r)-6-((r)-2-amino-2-phenylacetamido)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid Trihydrate

9. Chebi:31209

10. Poly-cillin

11. Ampicillin Hydrate

12. Amperil

13. Ampinova

14. Trafarbiot

15. Amcap

16. Cymbi

17. D-(-)-alpha-aminobenzylpenicillin

18. (2s,5r,6r)-6-{[(2r)-2-amino-2-phenylacetyl]amino}-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid Trihydrate

19. Ampicillin 3-wasser

20. Alpha-aminobenzylpenicillin Trihydrate

21. (2s,5r,6r)-6-[(2r)-2-amino-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid

22. (2s,5r,6r)-6-[[(2r)-2-amino-2-phenylacetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid Trihydrate

23. (2s,5r,6r)-6-[[(2r)-2-amino-2-phenylacetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid;trihydrate

24. Ccris 267

25. Unii-hxq6a1n7r6

26. (d-(-)-alpha-aminobenzyl)penicillin Trihydrate

27. Cas-7177-48-2

28. Amcill (tn)

29. Ampicilline Trihydrate

30. Dsstox_cid_83

31. Ampicillin Hydrate (jp17)

32. Dsstox_rid_75354

33. Dsstox_gsid_20083

34. Ampicillin Trihydrate, Sodium

35. Chembl453388

36. Ampicillin Hydrate [jan]

37. Ampicillin/ampicillin Monohydrate

38. Dtxsid9020083

39. Ampicillin Trihydrate [mi]

40. Hms1568g10

41. Hms2095g10

42. Hms3712g10

43. Tox21_201148

44. Ampicillin Trihydrate [vandf]

45. Mfcd00072036

46. S4148

47. Ampicillin Trihydrate [mart.]

48. Akos015915153

49. Ampicillin Trihydrate [usp-rs]

50. Ampicillin Trihydrate [who-dd]

51. Ampicillin Trihydrate [who-ip]

52. Ccg-220114

53. Ks-5251

54. Ncgc00023282-03

55. Ncgc00258700-01

56. 4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 6-(((2r)-aminophenylacetyl)amino)-3,3-dimethyl-7-oxo-, Trihydrate, (2s,5r,6r)-

57. 4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 6-((aminophenylacetyl)amino)-3,3-dimethyl-7-oxo-, Trihydrate, (2s-(2alpha,5alpha,6beta(s*)))-

58. 4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 6-(2-amino-2-phenylacetamido)-3,3-dimethyl-7-oxo-, Trihydrate, D- (-)-

59. Ampicillin Trihydrate [green Book]

60. Ampicillin Trihydrate [ep Monograph]

61. Ampicillin, Meets Usp Testing Specifications

62. D01251

63. 005a175

64. Sr-01000000061

65. Sr-01000000061-4

66. Ampicillin/ampicillin Trihydrate [orange Book]

67. Q27114210

68. Ampicillin Trihydrate, Vetranal(tm), Analytical Standard

69. Ampicillin Trihydrate, 96.0-100.5% Anhydrous Basis (hplc)

70. Ampicillin Trihydrate, British Pharmacopoeia (bp) Reference Standard

71. Ampicillin Trihydrate, European Pharmacopoeia (ep) Reference Standard

72. Ampicillin Trihydrate, United States Pharmacopeia (usp) Reference Standard

73. 6beta-[(2r)-2-amino-2-phenylacetamido]-2,2-dimethylpenam-3alpha-carboxylic Acid Trihydrate

74. Ampicillin Trihydrate, Pharmaceutical Secondary Standard; Certified Reference Material

75. (2s,5r,6r)-6-((r)-2-amino-2-phenylacetamido)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylicacidtrihydrate

76. 4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 6-(((2r)-2-amino-2-phenylacetyl)amino)-3,3-dimethyl-7-oxo-, Hydrate (1:3), (2s,5r,6r)-

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 403.5 g/mol
Molecular Formula C16H25N3O7S
Hydrogen Bond Donor Count6
Hydrogen Bond Acceptor Count9
Rotatable Bond Count4
Exact Mass403.14132132 g/mol
Monoisotopic Mass403.14132132 g/mol
Topological Polar Surface Area141 Ų
Heavy Atom Count27
Formal Charge0
Complexity562
Isotope Atom Count0
Defined Atom Stereocenter Count4
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count4
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameAmpicillin trihydrate
Drug LabelAmpicillin trihydrate is a semisynthetic penicillin derived from the basic penicillin nucleus, 6-aminopenicillanic acid. Ampicillin is designed chemically as (2S, 5R, 6R)-6-[(R)-2-Amino-2-phenylacetamido]-3, 3-dimethyl-7-oxo-4-this-l-azabicyclo[3.2.0...
Active IngredientAmpicillin/ampicillin trihydrate
Dosage FormCapsule; For suspension
RouteOral
Strengtheq 250mg base/5ml; eq 500mg base; eq 250mg base; eq 125mg base/5ml
Market StatusPrescription
CompanySandoz; Dava Pharms

2 of 2  
Drug NameAmpicillin trihydrate
Drug LabelAmpicillin trihydrate is a semisynthetic penicillin derived from the basic penicillin nucleus, 6-aminopenicillanic acid. Ampicillin is designed chemically as (2S, 5R, 6R)-6-[(R)-2-Amino-2-phenylacetamido]-3, 3-dimethyl-7-oxo-4-this-l-azabicyclo[3.2.0...
Active IngredientAmpicillin/ampicillin trihydrate
Dosage FormCapsule; For suspension
RouteOral
Strengtheq 250mg base/5ml; eq 500mg base; eq 250mg base; eq 125mg base/5ml
Market StatusPrescription
CompanySandoz; Dava Pharms

API Reference Price

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AREA,","city":"NAVI MUMBAI, MAHARASHTRA.","supplier":"SINOBRIGHT PHARMACEUTICAL INDUSTRIES LIMITED","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"AMN LIFE SCIENCE PRIVATE LIMITED","customerCountry":"INDIA","quantity":"5000.00","actualQuantity":"5000","unit":"KGS","unitRateFc":"34.1","totalValueFC":"172197.7","currency":"USD","unitRateINR":"2867.8","date":"27-Nov-2023","totalValueINR":"14339050","totalValueInUsd":"172197.7","indian_port":"JNPT","hs_no":"29411020","bill_no":"8961383","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"RM D 10\/F TOWER ABILLION CTR1 WANG KWONG RDKLN BAY KL ,HONG KONG CN","customerAddress":"W-444, TTC INDL. AREA,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1706812200,"product":"AMPICILLIN TRIHYDRATE COMPACTED BP","address":"W-444, TTC INDL. AREA,","city":"NAVI MUMBAI, MAHARASHTRA.","supplier":"SINOBRIGHT PHARMACEUTICAL INDUSTRIES LIMITED","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"AMN LIFE SCIENCE PRIVATE LIMITED","customerCountry":"INDIA","quantity":"111.00","actualQuantity":"111","unit":"KGS","unitRateFc":"34.1","totalValueFC":"3829.6","currency":"USD","unitRateINR":"2862.7","date":"02-Feb-2024","totalValueINR":"317759.15","totalValueInUsd":"3829.6","indian_port":"JNPT","hs_no":"29411020","bill_no":"9949210","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"RM D 10\/F TOWER ABILLION CTR1 WANG KWONG RDKLN BAY KL ,HONG KONG CN","customerAddress":"W-444, TTC INDL. AREA,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1706812200,"product":"AMPICILLIN TRIHYDRATE COMPACTED BP","address":"W-444, TTC INDL. AREA,","city":"NAVI MUMBAI, MAHARASHTRA.","supplier":"SINOBRIGHT PHARMACEUTICAL INDUSTRIES LIMITED","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"AMN LIFE SCIENCE PRIVATE LIMITED","customerCountry":"INDIA","quantity":"2889.00","actualQuantity":"2889","unit":"KGS","unitRateFc":"34.1","totalValueFC":"99674","currency":"USD","unitRateINR":"2862.7","date":"02-Feb-2024","totalValueINR":"8270325.86","totalValueInUsd":"99674","indian_port":"JNPT","hs_no":"29411020","bill_no":"9949210","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"RM D 10\/F TOWER ABILLION CTR1 WANG KWONG RDKLN BAY KL ,HONG KONG CN","customerAddress":"W-444, TTC INDL. AREA,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1717353000,"product":"AMPICILLIN TRIHYDRATE BP","address":"W-444, TTC INDL. 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AREA,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1736188200,"product":"AMPICILLIN TRIHYDRATE COMPACTED BP AMPICILLIN TRIHYDRATE COMPACTED BP","address":"D-44 ZAKIR NAGAR WEST","city":"NEW DELHI","supplier":"HONGKONG SUNRISEPHARMA CORPORATION LIMITED","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"ALCHEMY MEDICINE PRIVATE LIMITED","customerCountry":"INDIA","quantity":"373.00","actualQuantity":"373","unit":"KGS","unitRateFc":"32","totalValueFC":"11987.3","currency":"USD","unitRateINR":"2771.2","date":"07-Jan-2025","totalValueINR":"1033657.6","totalValueInUsd":"11987.3","indian_port":"Delhi PPG ICD","hs_no":"29411020","bill_no":"7654979","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"911B, TOWER A, HUNG HOM COMMERCIAL CENTRE, NO 39, MA TAU WAI ROAD, KOWLOON HONG KONG","customerAddress":"D-44 ZAKIR NAGAR WEST"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1736188200,"product":"AMPICILLIN TRIHYDRATE COMPACTED BP AMPICILLIN TRIHYDRATE COMPACTED BP","address":"D-44 ZAKIR NAGAR WEST","city":"NEW DELHI","supplier":"HONGKONG SUNRISEPHARMA CORPORATION LIMITED","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"ALCHEMY MEDICINE PRIVATE LIMITED","customerCountry":"INDIA","quantity":"375.00","actualQuantity":"375","unit":"KGS","unitRateFc":"32","totalValueFC":"12051.6","currency":"USD","unitRateINR":"2771.2","date":"07-Jan-2025","totalValueINR":"1039200","totalValueInUsd":"12051.6","indian_port":"Delhi PPG ICD","hs_no":"29411020","bill_no":"7654979","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"911B, TOWER A, HUNG HOM COMMERCIAL CENTRE, NO 39, MA TAU WAI ROAD, KOWLOON HONG KONG","customerAddress":"D-44 ZAKIR NAGAR WEST"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1736793000,"product":"AMOXICILLIN TRIHYDRATE COMPACTED EXTRA DRY CEP(INV.NO. 2024CS-0297A\/B+0299A)AMPICILLIN TRIHYDRATE COMPACTED","address":"PARIJAT HOUSE,","city":"MUMBAI ,MAHARASHTRA","supplier":"INNER MONGOLIA CHANGSHENG PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"TIANJIN","customer":"KOPRAN LIMITED","customerCountry":"INDIA","quantity":"1000.00","actualQuantity":"1000","unit":"KGS","unitRateFc":"31.5","totalValueFC":"31635.5","currency":"USD","unitRateINR":"2727.9","date":"14-Jan-2025","totalValueINR":"2727900","totalValueInUsd":"31635.5","indian_port":"JNPT","hs_no":"29411030","bill_no":"7779098","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"TIANJIN","supplierAddress":"CO., LTD. INDUSTRY ZONE, TUOKETUO H OHHOT, INNER MONGOLIA, CHINA SDNF CHINA","customerAddress":"PARIJAT HOUSE,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1736793000,"product":"AMOXICILLIN TRIHYDRATE POWDER CEP AMPICILLIN TRIHYDRATE POWDER CEP","address":"PARIJAT HOUSE,","city":"MUMBAI ,MAHARASHTRA","supplier":"INNER MONGOLIA CHANGSHENG PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"TIANJIN","customer":"KOPRAN LIMITED","customerCountry":"INDIA","quantity":"1000.00","actualQuantity":"1000","unit":"KGS","unitRateFc":"31","totalValueFC":"31133.3","currency":"USD","unitRateINR":"2684.6","date":"14-Jan-2025","totalValueINR":"2684600","totalValueInUsd":"31133.3","indian_port":"JNPT","hs_no":"29411030","bill_no":"7779098","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"TIANJIN","supplierAddress":"CO., LTD. INDUSTRY ZONE, TUOKETUO H OHHOT, INNER MONGOLIA, CHINA SDNF CHINA","customerAddress":"PARIJAT HOUSE,"}]
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ABOUT THIS PAGE

Looking for 7177-48-2 / Ampicillin Trihydrate API manufacturers, exporters & distributors?

Ampicillin Trihydrate manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Ampicillin Trihydrate 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 Ampicillin Trihydrate manufacturer or Ampicillin Trihydrate supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ampicillin Trihydrate manufacturer or Ampicillin Trihydrate supplier.

PharmaCompass also assists you with knowing the Ampicillin Trihydrate API Price utilized in the formulation of products. Ampicillin Trihydrate API Price is not always fixed or binding as the Ampicillin Trihydrate Price is obtained through a variety of data sources. The Ampicillin Trihydrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Ampicillin Trihydrate

Synonyms

615-347-9, 7177-48-2, Aminobenzylpenicillin trihydrate, Penbritin, Nci-c56086, Ampicillin/ampicillin trihydrate

Cas Number

7177-48-2

Unique Ingredient Identifier (UNII)

HXQ6A1N7R6

About Ampicillin Trihydrate

Ampicillin Trihydrate is the trihydrate form of ampicillin, a broad-spectrum semisynthetic derivative of aminopenicillin. Ampicillin trihydrate inhibits bacterial cell wall synthesis by binding to penicillin binding proteins, thereby inhibiting peptidoglycan synthesis, a critical component of the bacterial cell wall.

Ampicillin Trihydrate Manufacturers

A Ampicillin Trihydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ampicillin Trihydrate, including repackagers and relabelers. The FDA regulates Ampicillin Trihydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ampicillin Trihydrate 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 Ampicillin Trihydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Ampicillin Trihydrate Suppliers

A Ampicillin Trihydrate supplier is an individual or a company that provides Ampicillin Trihydrate active pharmaceutical ingredient (API) or Ampicillin Trihydrate finished formulations upon request. The Ampicillin Trihydrate suppliers may include Ampicillin Trihydrate API manufacturers, exporters, distributors and traders.

click here to find a list of Ampicillin Trihydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Ampicillin Trihydrate USDMF

A Ampicillin Trihydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Ampicillin Trihydrate active pharmaceutical ingredient (API) in detail. Different forms of Ampicillin Trihydrate DMFs exist exist since differing nations have different regulations, such as Ampicillin Trihydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Ampicillin Trihydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Ampicillin Trihydrate USDMF includes data on Ampicillin Trihydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ampicillin Trihydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Ampicillin Trihydrate suppliers with USDMF on PharmaCompass.

Ampicillin Trihydrate JDMF

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 Ampicillin Trihydrate Drug Master File in Japan (Ampicillin Trihydrate JDMF) empowers Ampicillin Trihydrate 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 Ampicillin Trihydrate JDMF during the approval evaluation for pharmaceutical products. At the time of Ampicillin Trihydrate 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 Ampicillin Trihydrate suppliers with JDMF on PharmaCompass.

Ampicillin Trihydrate CEP

A Ampicillin Trihydrate CEP of the European Pharmacopoeia monograph is often referred to as a Ampicillin Trihydrate Certificate of Suitability (COS). The purpose of a Ampicillin Trihydrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ampicillin Trihydrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ampicillin Trihydrate to their clients by showing that a Ampicillin Trihydrate CEP has been issued for it. The manufacturer submits a Ampicillin Trihydrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ampicillin Trihydrate CEP holder for the record. Additionally, the data presented in the Ampicillin Trihydrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ampicillin Trihydrate DMF.

A Ampicillin Trihydrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ampicillin Trihydrate 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 Ampicillin Trihydrate suppliers with CEP (COS) on PharmaCompass.

Ampicillin Trihydrate WC

A Ampicillin Trihydrate written confirmation (Ampicillin Trihydrate WC) is an official document issued by a regulatory agency to a Ampicillin Trihydrate manufacturer, verifying that the manufacturing facility of a Ampicillin Trihydrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ampicillin Trihydrate APIs or Ampicillin Trihydrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Ampicillin Trihydrate WC (written confirmation) as part of the regulatory process.

click here to find a list of Ampicillin Trihydrate suppliers with Written Confirmation (WC) on PharmaCompass.

Ampicillin Trihydrate NDC

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 Ampicillin Trihydrate as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Ampicillin Trihydrate API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Ampicillin Trihydrate 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Ampicillin Trihydrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ampicillin Trihydrate NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Ampicillin Trihydrate suppliers with NDC on PharmaCompass.

Ampicillin Trihydrate GMP

Ampicillin Trihydrate 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 Ampicillin Trihydrate 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 Ampicillin Trihydrate GMP manufacturer or Ampicillin Trihydrate GMP API supplier for your needs.

Ampicillin Trihydrate CoA

A Ampicillin Trihydrate CoA (Certificate of Analysis) is a formal document that attests to Ampicillin Trihydrate's compliance with Ampicillin Trihydrate specifications and serves as a tool for batch-level quality control.

Ampicillin Trihydrate CoA mostly includes findings from lab analyses of a specific batch. For each Ampicillin Trihydrate 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.

Ampicillin Trihydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Ampicillin Trihydrate EP), Ampicillin Trihydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ampicillin Trihydrate USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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