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1. Amcill
2. Aminobenzyl Penicillin
3. Aminobenzylpenicillin
4. Ampicillin
5. Ampicillin Trihydrate
6. Antibiotic Ks R1
7. Antibiotic Ks-r1
8. Ks-r1, Antibiotic
9. Omnipen
10. Penicillin, Aminobenzyl
11. Pentrexyl
12. Polycillin
13. Sodium, Ampicillin
14. Trihydrate, Ampicillin
15. Ukapen
1. 200-708-1
2. 69-52-3
3. Ampicillin Sodium Salt
4. Sodium Ampicillin
5. Citteral
6. Domicillin
7. Penialmen
8. Ampicillin Natrium
9. Omnipen
10. Penbritin
11. Totacillin
12. Ampicillin (sodium)
13. Austrapen
14. Polycillin-n
15. Sodium D-(-)-alpha-aminobenzylpenicillin
16. Totacillin-n
17. Penbritin-s
18. Omnipen-n
19. Ampicillin (as Sodium)
20. Jfn36l5s8k
21. Mls000028726
22. D(-)-alpha-aminobenzylpenicillin Sodium Salt
23. Chebi:34535
24. Nsc-755864
25. Smr000059229
26. Monosodium D-(-)-6-(2-amino-2-phenylacetamido)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylate
27. Sodium (2s,5r,6r)-6-((r)-2-amino-2-phenylacetamido)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate
28. Ampicillinsodium
29. Binotal Sodium
30. Sodium Binotal
31. Principen/n
32. Amcill-s
33. Alpen-n
34. Sodium;(2s,5r,6r)-6-[[(2r)-2-amino-2-phenylacetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate
35. Sodium P-50
36. Mfcd00064313
37. Pen A/n
38. Unii-jfn36l5s8k
39. Ampiplus Simplex
40. Viccillin (tn)
41. Prestwick_822
42. Ampicillin Sodium [usan:usp:jan]
43. Einecs 200-708-1
44. Ampicillinum Natricum
45. Omnipen-n (tn)
46. Ampicillin Sodium Salt, Cell Culture Grade
47. Opera_id_709
48. (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 Sodium Salt
49. Ampicillinsodiumsalt
50. Ampicillin Sodium, Sterile
51. Schembl40521
52. Spectrum1500123
53. Ampicillin Sodium [jan]
54. Ampicillin Sodium (jp17/usp)
55. Ampicillin Sodium [usan]
56. Chembl1200758
57. Hms501h08
58. Hy-b0522a
59. Ampicillin Sodium [vandf]
60. Dtxsid60988759
61. Ampicillin Sodium [mart.]
62. Hms1920c21
63. Hms2091i21
64. Hms2232j12
65. Ampicillin Sodium [usp-rs]
66. Ampicillin Sodium [who-dd]
67. Ampicillin Sodium [who-ip]
68. Ampicillin Sodium Salt [mi]
69. Ccg-39691
70. S3170
71. Akos015967315
72. Akos025147373
73. Ampicillin Sodium [green Book]
74. Ac-8806
75. Ampicillin Sodium [orange Book]
76. Nsc 755864
77. Ampicillin Sodium [ep Monograph]
78. Ampicillin Sodium [usp Monograph]
79. D-(-)-alpha-aminobenzylpenicillin &sdot
80. 4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 6-((aminophenylacetyl)amino)-3,3-dimethyl-7-oxo-, Monosodium Salt, (2s-(2alpha,5alpha,6beta(s*)))-
81. Ba166035
82. Monosodium (2s,5r,6r)-6-((r)-2-amino-2-phenylacetamido)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylate
83. D-(-)-a-aminobenzylpenicillin Sodium Salt
84. Ampicillin Sodium, Sterile [who-ip]
85. Ampicillinum Natricum [who-ip Latin]
86. Sw220219-1
87. A-7700
88. D02119
89. A836527
90. Ampicillin Sodium (non-injectable) [who-ip]
91. Q27116136
92. Ampicillin Sodium Salt, Antibiotic For Culture Media Use Only
93. Sodium 6beta-[(2r)-2-amino-2-phenylacetamido]-2,2-dimethylpenam-3alpha-carboxylate
94. (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, Sodium Salt (1:1)
95. 4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 6-((aminophenylacetyl)amino)-3,3-dimethyl-7-oxo-, Monosodium Salt, (2s-(2.alpha.,5.alpha.,6.beta.(s*)))-
96. 4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 6-(2-amino-2-phenylacetamido)-3,3-dimethyl-7-oxo-, Sodium Salt, D-(-)-
97. 6-(2-amino-2-phenylacetamido)-3,3-dimethyl-7-oxo-,sodiumsalt,d-(-)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylicacid
98. Sodium (2s-(2alpha,5alpha,6beta(s*)))-6-(aminophenylacetamido)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylate
99. Sodium(2s,5r,6r)-6-((r)-2-amino-2-phenylacetamido)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate
| Molecular Weight | 371.4 g/mol |
|---|---|
| Molecular Formula | C16H18N3NaO4S |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 6 |
| Rotatable Bond Count | 4 |
| Exact Mass | 371.09157152 g/mol |
| Monoisotopic Mass | 371.09157152 g/mol |
| Topological Polar Surface Area | 141 Ų |
| Heavy Atom Count | 25 |
| Formal Charge | 0 |
| Complexity | 568 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 4 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
| 1 of 2 | |
|---|---|
| Drug Name | Ampicillin sodium |
| Drug Label | Ampicillin for Injection, USP the monosodium salt of [2S-[2,5,6(S*)]]-6- [(aminophenylacetyl)amino]-3,3-dimethyl-7-oxo-4thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, is a synthetic penicillin for intramuscular or intravenous use. The pha... |
| Active Ingredient | Ampicillin sodium |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | eq 2gm base/vial; eq 125mg base/vial; eq 500mg base/vial; eq 10gm base/vial; eq 250mg base/vial; eq 1gm base/vial |
| Market Status | Prescription |
| Company | Istituto Bio Ita Spa; Antibiotice; Hanford Gc; Acs Dobfar Spa; Aurobindo Pharma; Strides Arcolab; Sandoz; Agila Speclts |
| 2 of 2 | |
|---|---|
| Drug Name | Ampicillin sodium |
| Drug Label | Ampicillin for Injection, USP the monosodium salt of [2S-[2,5,6(S*)]]-6- [(aminophenylacetyl)amino]-3,3-dimethyl-7-oxo-4thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, is a synthetic penicillin for intramuscular or intravenous use. The pha... |
| Active Ingredient | Ampicillin sodium |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | eq 2gm base/vial; eq 125mg base/vial; eq 500mg base/vial; eq 10gm base/vial; eq 250mg base/vial; eq 1gm base/vial |
| Market Status | Prescription |
| Company | Istituto Bio Ita Spa; Antibiotice; Hanford Gc; Acs Dobfar Spa; Aurobindo Pharma; Strides Arcolab; Sandoz; Agila Speclts |
Anti-Bacterial Agents
Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)
API SUPPLIERS
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16451
Submission : 2003-03-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13661
Submission : 1998-09-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-26
Pay. Date : 2014-05-19
DMF Number : 20211
Submission : 2007-01-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8109
Submission : 1989-06-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13532
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13480
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13742
Submission : 1998-09-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13425
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-04-20
Pay. Date : 2023-04-17
DMF Number : 13754
Submission : 1998-09-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13379
Submission : 1998-09-01
Status : Inactive
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] JDMF
Registration Number : 219MF10051
Registrant's Address : Viale Addetta, 4/12, 20067 Tribiano (Milan) Italy
Initial Date of Registration : 2007-02-13
Latest Date of Registration : 2007-02-13
Registration Number : 302MF10023
Registrant's Address : Plot No. 2, Maitrivihar, Ameerpet, Hyderabad Telangana, India
Initial Date of Registration : 2020-02-06
Latest Date of Registration : 2020-02-06
Registration Number : 302MF10114
Registrant's Address : No. 88 Yangzi Road, Economic & Technological Development Zone, Shijiazhuang City, Heb...
Initial Date of Registration : 2020-09-24
Latest Date of Registration : 2023-03-01
Registration Number : 217MF11156
Registrant's Address : 2-4-16 Kyobashi, Chuo-ku, Tokyo
Initial Date of Registration : 2005-12-12
Latest Date of Registration : 2014-09-01
Registration Number : 226MF10211
Registrant's Address : No. 20 Yangzi Road, Shijiazhuang Economic and Technological Development Zone, Hebei 0...
Initial Date of Registration : 2014-11-17
Latest Date of Registration : 2014-11-17
Registration Number : 217MF10454
Registrant's Address : Biochemiesstrasse 10,6250 Kundl, Austria
Initial Date of Registration : 2005-08-24
Latest Date of Registration : 2006-09-22
Registration Number : 230MF10039
Registrant's Address : No. 9, Ren'an section, Health Road, Jiulong Town (Industrial Park) Yuechi, Sichuan.
Initial Date of Registration : 2018-02-28
Latest Date of Registration : 2023-02-08
Registration Number : 301MF10053
Registrant's Address : No. 2428, Anji Road, Sanzao Town, Jinwan District, Zhuhai, Guangdong-519040, P. R. Ch...
Initial Date of Registration : 2019-08-28
Latest Date of Registration : 2019-08-28
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
Registrant Name : Samjin Pharmaceutical Co., Ltd.
Registration Date : 2021-09-27
Registration Number : 20201104-210-J-578(1)
Manufacturer Name : Apitoria Pharma Private Limi...
Manufacturer Address : Plot No. 68-70, 73-91,95,96,260,261, IDA, Pashamylaram Village, Patancheru Mandal, Sa...
Registrant Name : Sungwoo Chemical Co., Ltd.
Registration Date : 2020-11-04
Registration Number : 20201104-210-J-578
Manufacturer Name : Apitoria Pharma Private Limi...
Manufacturer Address : Plot No. 68-70, 73-91,95,96,260,261, IDA, Pashamylaram Village, Patancheru Mandal, Sa...
Registrant Name : Lee Sung International Co., Ltd.
Registration Date : 2021-11-05
Registration Number : 20200603-210-J-404(1)
Manufacturer Name : Sandoz GmbH@Sandoz Industria...
Manufacturer Address : Biochemiestraβe 10 6250 Kundl Austria@Ctra. Granollers - Cardedeu C-251, km 4 08520 ...
Registrant Name : Korea Pfizer Pharmaceutical Co., Ltd.
Registration Date : 2020-06-03
Registration Number : 20200603-210-J-404
Manufacturer Name : Sandoz GmbH@Sandoz Industria...
Manufacturer Address : Biochemiestraβe 10 6250 Kundl Austria@Ctra. Granollers - Cardedeu C-251, km 4 08520 ...
Registrant Name : Hiple Co., Ltd.
Registration Date : 2023-05-12
Registration Number : 20230512-210-J-1491
Manufacturer Name : Sichuan Renan Pharmaceutical...
Manufacturer Address : No 9, Ren' an Section, Health road, Jiulong Town (Industrial Park) Yuechi, Sichuan, 6...
Registrant Name : Seongi Bio Co., Ltd.
Registration Date : 2020-08-13
Registration Number : 20200813-210-J-589
Manufacturer Name : Zhuhai United Laboratories C...
Manufacturer Address : No. 2428, Anji Road, Sanzao Town, Jinwan District, Zhuhai, Guangdong, 519040, PR Chin...
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Ampicillin Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ampicillin Sodium, including repackagers and relabelers. The FDA regulates Ampicillin Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ampicillin Sodium 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 Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ampicillin Sodium supplier is an individual or a company that provides Ampicillin Sodium active pharmaceutical ingredient (API) or Ampicillin Sodium finished formulations upon request. The Ampicillin Sodium suppliers may include Ampicillin Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Ampicillin Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ampicillin Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Ampicillin Sodium active pharmaceutical ingredient (API) in detail. Different forms of Ampicillin Sodium DMFs exist exist since differing nations have different regulations, such as Ampicillin Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ampicillin Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Ampicillin Sodium USDMF includes data on Ampicillin Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ampicillin Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ampicillin Sodium 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 Ampicillin Sodium Drug Master File in Japan (Ampicillin Sodium JDMF) empowers Ampicillin Sodium 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 Sodium JDMF during the approval evaluation for pharmaceutical products. At the time of Ampicillin Sodium 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 Sodium suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Ampicillin Sodium Drug Master File in Korea (Ampicillin Sodium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ampicillin Sodium. The MFDS reviews the Ampicillin Sodium KDMF as part of the drug registration process and uses the information provided in the Ampicillin Sodium KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ampicillin Sodium KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Ampicillin Sodium API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ampicillin Sodium suppliers with KDMF on PharmaCompass.
A Ampicillin Sodium CEP of the European Pharmacopoeia monograph is often referred to as a Ampicillin Sodium Certificate of Suitability (COS). The purpose of a Ampicillin Sodium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ampicillin Sodium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ampicillin Sodium to their clients by showing that a Ampicillin Sodium CEP has been issued for it. The manufacturer submits a Ampicillin Sodium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ampicillin Sodium CEP holder for the record. Additionally, the data presented in the Ampicillin Sodium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ampicillin Sodium DMF.
A Ampicillin Sodium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ampicillin Sodium 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 Sodium suppliers with CEP (COS) on PharmaCompass.
A Ampicillin Sodium written confirmation (Ampicillin Sodium WC) is an official document issued by a regulatory agency to a Ampicillin Sodium manufacturer, verifying that the manufacturing facility of a Ampicillin Sodium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ampicillin Sodium APIs or Ampicillin Sodium finished pharmaceutical products to another nation, regulatory agencies frequently require a Ampicillin Sodium WC (written confirmation) as part of the regulatory process.
click here to find a list of Ampicillin Sodium 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 Ampicillin Sodium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ampicillin Sodium 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 Ampicillin Sodium 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 Ampicillin Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ampicillin Sodium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ampicillin Sodium suppliers with NDC on PharmaCompass.
Ampicillin Sodium 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 Sodium 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 Sodium GMP manufacturer or Ampicillin Sodium GMP API supplier for your needs.
A Ampicillin Sodium CoA (Certificate of Analysis) is a formal document that attests to Ampicillin Sodium's compliance with Ampicillin Sodium specifications and serves as a tool for batch-level quality control.
Ampicillin Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Ampicillin Sodium 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 Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Ampicillin Sodium EP), Ampicillin Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ampicillin Sodium USP).
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