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1. Tazocin (tn)
2. Zosyn (tn)
3. Piperacillin-tazobactam Mixt.
4. Piperacillin-tazobactam Mixture
5. Niosh/xi0191450
6. Piperacillin Sodium And Tazobactam
7. Dtxsid001016418
8. Tazobactam And Piperacillin (jp17)
9. Piperacillin-tazobactam Mixt. (4:1)
10. Tazobactam-piperacillin Mixt. (1:4)
11. Xi01914500
12. D02505
13. 4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 3-methyl-7-oxo-3-(1h-1,2,3-triazol-1-ylmethyl)-, 4,4-dioxide, (2s-(2-alpha,3-beta,5-alpha))-, Mixt. With (2s-(2-alpha,5-alpha,6-beta(s*)))-6-(((((4-ethyl-2,3-dioxo-1-piperazinyl)carbonyl)amino)phenylacetyl)amino)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid (1:4)
14. Sodium;(2s,5r,6r)-6-[[(2s)-2-[(4-ethyl-2,3-dioxopiperazine-1-carbonyl)amino]-2-phenylacetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate;(2s,3s,5r)-3-methyl-4,4,7-trioxo-3-(triazol-1-ylmethyl)-4lambda6-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid
Molecular Weight | 839.8 g/mol |
---|---|
Molecular Formula | C33H38N9NaO12S2 |
Hydrogen Bond Donor Count | 3 |
Hydrogen Bond Acceptor Count | 15 |
Rotatable Bond Count | 9 |
Exact Mass | 839.19790431 g/mol |
Monoisotopic Mass | 839.19790431 g/mol |
Topological Polar Surface Area | 315 Ų |
Heavy Atom Count | 57 |
Formal Charge | 0 |
Complexity | 1560 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 7 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 3 |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36317
Submission : 2022-10-13
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-31
Pay. Date : 2013-12-17
DMF Number : 25545
Submission : 2011-11-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20432
Submission : 2007-04-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-10-07
Pay. Date : 2013-01-09
DMF Number : 26009
Submission : 2012-03-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-05-14
Pay. Date : 2019-02-20
DMF Number : 33540
Submission : 2019-02-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18903
Submission : 2005-10-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29994
Submission : 2016-11-28
Status : Active
Type : II
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ABOUT THIS PAGE
A Piperacillin + Tazobactam manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Piperacillin + Tazobactam, including repackagers and relabelers. The FDA regulates Piperacillin + Tazobactam manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Piperacillin + Tazobactam 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 Piperacillin + Tazobactam manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Piperacillin + Tazobactam supplier is an individual or a company that provides Piperacillin + Tazobactam active pharmaceutical ingredient (API) or Piperacillin + Tazobactam finished formulations upon request. The Piperacillin + Tazobactam suppliers may include Piperacillin + Tazobactam API manufacturers, exporters, distributors and traders.
click here to find a list of Piperacillin + Tazobactam suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Piperacillin + Tazobactam DMF (Drug Master File) is a document detailing the whole manufacturing process of Piperacillin + Tazobactam active pharmaceutical ingredient (API) in detail. Different forms of Piperacillin + Tazobactam DMFs exist exist since differing nations have different regulations, such as Piperacillin + Tazobactam USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Piperacillin + Tazobactam DMF submitted to regulatory agencies in the US is known as a USDMF. Piperacillin + Tazobactam USDMF includes data on Piperacillin + Tazobactam's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Piperacillin + Tazobactam USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Piperacillin + Tazobactam suppliers with USDMF 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 Piperacillin + Tazobactam Drug Master File in Korea (Piperacillin + Tazobactam KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Piperacillin + Tazobactam. The MFDS reviews the Piperacillin + Tazobactam KDMF as part of the drug registration process and uses the information provided in the Piperacillin + Tazobactam KDMF to evaluate the safety and efficacy of the drug.
After submitting a Piperacillin + Tazobactam 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 Piperacillin + Tazobactam API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Piperacillin + Tazobactam suppliers with KDMF on PharmaCompass.
A Piperacillin + Tazobactam written confirmation (Piperacillin + Tazobactam WC) is an official document issued by a regulatory agency to a Piperacillin + Tazobactam manufacturer, verifying that the manufacturing facility of a Piperacillin + Tazobactam active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Piperacillin + Tazobactam APIs or Piperacillin + Tazobactam finished pharmaceutical products to another nation, regulatory agencies frequently require a Piperacillin + Tazobactam WC (written confirmation) as part of the regulatory process.
click here to find a list of Piperacillin + Tazobactam 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 Piperacillin + Tazobactam as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Piperacillin + Tazobactam 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 Piperacillin + Tazobactam 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 Piperacillin + Tazobactam and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Piperacillin + Tazobactam NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Piperacillin + Tazobactam suppliers with NDC on PharmaCompass.
Piperacillin + Tazobactam 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 Piperacillin + Tazobactam 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 Piperacillin + Tazobactam GMP manufacturer or Piperacillin + Tazobactam GMP API supplier for your needs.
A Piperacillin + Tazobactam CoA (Certificate of Analysis) is a formal document that attests to Piperacillin + Tazobactam's compliance with Piperacillin + Tazobactam specifications and serves as a tool for batch-level quality control.
Piperacillin + Tazobactam CoA mostly includes findings from lab analyses of a specific batch. For each Piperacillin + Tazobactam 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.
Piperacillin + Tazobactam may be tested according to a variety of international standards, such as European Pharmacopoeia (Piperacillin + Tazobactam EP), Piperacillin + Tazobactam JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Piperacillin + Tazobactam USP).
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