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1. Bencelin
2. Benzathine Benzylpnicilline Panpharma
3. Benzathine Benzylpenicillin
4. Benzathine Penicillin
5. Benzathine, Penicillin G
6. Benzetacil
7. Benzylpenicillin, Benzathine
8. Bicillin
9. Bicillin L A
10. Bicillin La
11. Brevicilina
12. Cepacilina
13. Debecillin
14. Extencilline
15. Pendepon
16. Penduran
17. Pendysin
18. Penicillin G Benzathine
19. Penicillin G Benzathine Anhydrous
20. Penicillin, Benzathine
21. Penidural
22. Peniroger Retard
23. Permapen
24. Provipen Benzatina
25. Tardocillin
1. Benzathine Benzylpenicillin
2. Cepacilina
3. Lentopenil
4. Tardocillin
5. Beacillin
6. Penidural
7. Chebi:51352
8. Benzylpenicillin Dibenzylethylenediamine Salt
9. Penicillin G Salt Of N,n'-dibenzylethylenediamine
10. N,n'-dibenzylethylenediamine Bis(benzyl Penicillin)
11. Epitope Id:224559
12. Db09323
13. N,n'-dibenzylethane-1,2-diaminium Bis{2,2-dimethyl-6beta-(phenylacetamido)penam-3alpha-carboxylate}
Molecular Weight | 909.1 g/mol |
---|---|
Molecular Formula | C48H56N6O8S2 |
Hydrogen Bond Donor Count | 4 |
Hydrogen Bond Acceptor Count | 10 |
Rotatable Bond Count | 13 |
Exact Mass | 908.36010511 g/mol |
Monoisotopic Mass | 908.36010511 g/mol |
Topological Polar Surface Area | 263 Ų |
Heavy Atom Count | 64 |
Formal Charge | 0 |
Complexity | 696 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 6 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 3 |
1 of 2 | |
---|---|
Drug Name | Bicillin l-a |
PubMed Health | Penicillin G Benzathine (Injection) |
Drug Classes | Antibiotic |
Drug Label | Bicillin L-A (penicillin G benzathine injectable suspension) is available for deep intramuscular injection. Penicillin G benzathine is prepared by the reaction of dibenzylethylene diamine with two molecules of penicillin G. It is chemically designate... |
Active Ingredient | Penicillin g benzathine |
Dosage Form | Injectable |
Route | Injection |
Strength | 300,000 units/ml; 600,000 units/ml |
Market Status | Prescription |
Company | King Pharms |
2 of 2 | |
---|---|
Drug Name | Bicillin l-a |
PubMed Health | Penicillin G Benzathine (Injection) |
Drug Classes | Antibiotic |
Drug Label | Bicillin L-A (penicillin G benzathine injectable suspension) is available for deep intramuscular injection. Penicillin G benzathine is prepared by the reaction of dibenzylethylene diamine with two molecules of penicillin G. It is chemically designate... |
Active Ingredient | Penicillin g benzathine |
Dosage Form | Injectable |
Route | Injection |
Strength | 300,000 units/ml; 600,000 units/ml |
Market Status | Prescription |
Company | King Pharms |
Anti-Bacterial Agents
Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)
J - Antiinfectives for systemic use
J01 - Antibacterials for systemic use
J01C - Beta-lactam antibacterials, penicillins
J01CE - Beta-lactamase sensitive penicillins
J01CE08 - Benzathine benzylpenicillin
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
GDUFA
DMF Review : Reviewed
Rev. Date : 2025-05-12
Pay. Date : 2025-03-07
DMF Number : 40297
Submission : 2025-03-17
Status : Active
Type : II
NDC Package Code : 66558-0198
Start Marketing Date : 2024-08-30
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-04-19
Pay. Date : 2018-03-23
DMF Number : 13294
Submission : 1998-09-01
Status : Active
Type : II
Certificate Number : R1-CEP 2001-066 - Rev 05
Issue Date : 2023-07-26
Type : Chemical
Substance Number : 373
Status : Valid
NDC Package Code : 43858-510
Start Marketing Date : 2010-02-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (10kg/10kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13318
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13328
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13655
Submission : 1998-09-01
Status : Inactive
Type : II
Registration Number : 219MF10336
Registrant's Address : 15 Dongfeng Rd. , Leping City, Jiangxi Province, China
Initial Date of Registration : 2007-11-21
Latest Date of Registration :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13655
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2025-05-12
Pay. Date : 2025-03-07
DMF Number : 40297
Submission : 2025-03-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13318
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-04-19
Pay. Date : 2018-03-23
DMF Number : 13294
Submission : 1998-09-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13328
Submission : 1998-09-01
Status : Inactive
Type : II
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PharmaCompass offers a list of Benzathine Benzylpenicilline 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 Benzathine Benzylpenicilline manufacturer or Benzathine Benzylpenicilline supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Benzathine Benzylpenicilline manufacturer or Benzathine Benzylpenicilline supplier.
PharmaCompass also assists you with knowing the Benzathine Benzylpenicilline API Price utilized in the formulation of products. Benzathine Benzylpenicilline API Price is not always fixed or binding as the Benzathine Benzylpenicilline Price is obtained through a variety of data sources. The Benzathine Benzylpenicilline Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A G Benzathine, Penicillin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of G Benzathine, Penicillin, including repackagers and relabelers. The FDA regulates G Benzathine, Penicillin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. G Benzathine, Penicillin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A G Benzathine, Penicillin supplier is an individual or a company that provides G Benzathine, Penicillin active pharmaceutical ingredient (API) or G Benzathine, Penicillin finished formulations upon request. The G Benzathine, Penicillin suppliers may include G Benzathine, Penicillin API manufacturers, exporters, distributors and traders.
click here to find a list of G Benzathine, Penicillin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A G Benzathine, Penicillin DMF (Drug Master File) is a document detailing the whole manufacturing process of G Benzathine, Penicillin active pharmaceutical ingredient (API) in detail. Different forms of G Benzathine, Penicillin DMFs exist exist since differing nations have different regulations, such as G Benzathine, Penicillin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A G Benzathine, Penicillin DMF submitted to regulatory agencies in the US is known as a USDMF. G Benzathine, Penicillin USDMF includes data on G Benzathine, Penicillin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The G Benzathine, Penicillin USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 G Benzathine, Penicillin Drug Master File in Japan (G Benzathine, Penicillin JDMF) empowers G Benzathine, Penicillin 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 G Benzathine, Penicillin JDMF during the approval evaluation for pharmaceutical products. At the time of G Benzathine, Penicillin JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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A G Benzathine, Penicillin CEP of the European Pharmacopoeia monograph is often referred to as a G Benzathine, Penicillin Certificate of Suitability (COS). The purpose of a G Benzathine, Penicillin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of G Benzathine, Penicillin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of G Benzathine, Penicillin to their clients by showing that a G Benzathine, Penicillin CEP has been issued for it. The manufacturer submits a G Benzathine, Penicillin CEP (COS) as part of the market authorization procedure, and it takes on the role of a G Benzathine, Penicillin CEP holder for the record. Additionally, the data presented in the G Benzathine, Penicillin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the G Benzathine, Penicillin DMF.
A G Benzathine, Penicillin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. G Benzathine, Penicillin CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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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 G Benzathine, Penicillin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for G Benzathine, Penicillin 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 G Benzathine, Penicillin 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 G Benzathine, Penicillin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a G Benzathine, Penicillin NDC to their finished compounded human drug products, they may choose to do so.
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G Benzathine, Penicillin 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 G Benzathine, Penicillin 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 G Benzathine, Penicillin GMP manufacturer or G Benzathine, Penicillin GMP API supplier for your needs.
A G Benzathine, Penicillin CoA (Certificate of Analysis) is a formal document that attests to G Benzathine, Penicillin's compliance with G Benzathine, Penicillin specifications and serves as a tool for batch-level quality control.
G Benzathine, Penicillin CoA mostly includes findings from lab analyses of a specific batch. For each G Benzathine, Penicillin 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.
G Benzathine, Penicillin may be tested according to a variety of international standards, such as European Pharmacopoeia (G Benzathine, Penicillin EP), G Benzathine, Penicillin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (G Benzathine, Penicillin USP).