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API SUPPLIERS
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USDMF
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DOSAGE - INJECTABLE;INJECTION - EQ 2GM BASE/V...DOSAGE - INJECTABLE;INJECTION - EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50684
DOSAGE - INJECTABLE;INJECTION - EQ 36GM BASE/...DOSAGE - INJECTABLE;INJECTION - EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50684
DOSAGE - INJECTABLE;INJECTION - EQ 3GM BASE/V...DOSAGE - INJECTABLE;INJECTION - EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50684
DOSAGE - INJECTABLE;INJECTION - EQ 4GM BASE/V...DOSAGE - INJECTABLE;INJECTION - EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50684
DOSAGE - INJECTABLE;INJECTION - EQ 40MG BASE/...DOSAGE - INJECTABLE;INJECTION - EQ 40MG BASE/ML;EQ 5MG BASE/ML
USFDA APPLICATION NUMBER - 50750
DOSAGE - INJECTABLE;INJECTION - EQ 4GM BASE/1...DOSAGE - INJECTABLE;INJECTION - EQ 4GM BASE/100ML;EQ 500MG BASE/100ML
USFDA APPLICATION NUMBER - 50750
DOSAGE - INJECTABLE;INJECTION - EQ 60MG BASE/...DOSAGE - INJECTABLE;INJECTION - EQ 60MG BASE/ML;EQ 7.5MG BASE/ML
USFDA APPLICATION NUMBER - 50750
Related Excipient Companies
SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kirsch Pharma
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Fillers, Diluents & Binders
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PharmaCompass offers a list of Piperacillin Sodium 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 Piperacillin Sodium manufacturer or Piperacillin Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Piperacillin Sodium manufacturer or Piperacillin Sodium supplier.
PharmaCompass also assists you with knowing the Piperacillin Sodium API Price utilized in the formulation of products. Piperacillin Sodium API Price is not always fixed or binding as the Piperacillin Sodium Price is obtained through a variety of data sources. The Piperacillin Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A ZOSYN manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ZOSYN, including repackagers and relabelers. The FDA regulates ZOSYN manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ZOSYN 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 ZOSYN manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A ZOSYN supplier is an individual or a company that provides ZOSYN active pharmaceutical ingredient (API) or ZOSYN finished formulations upon request. The ZOSYN suppliers may include ZOSYN API manufacturers, exporters, distributors and traders.
click here to find a list of ZOSYN suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A ZOSYN DMF (Drug Master File) is a document detailing the whole manufacturing process of ZOSYN active pharmaceutical ingredient (API) in detail. Different forms of ZOSYN DMFs exist exist since differing nations have different regulations, such as ZOSYN USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A ZOSYN DMF submitted to regulatory agencies in the US is known as a USDMF. ZOSYN USDMF includes data on ZOSYN's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The ZOSYN USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of ZOSYN 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 ZOSYN Drug Master File in Japan (ZOSYN JDMF) empowers ZOSYN 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 ZOSYN JDMF during the approval evaluation for pharmaceutical products. At the time of ZOSYN 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 ZOSYN 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 ZOSYN Drug Master File in Korea (ZOSYN KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of ZOSYN. The MFDS reviews the ZOSYN KDMF as part of the drug registration process and uses the information provided in the ZOSYN KDMF to evaluate the safety and efficacy of the drug.
After submitting a ZOSYN 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 ZOSYN API can apply through the Korea Drug Master File (KDMF).
click here to find a list of ZOSYN suppliers with KDMF on PharmaCompass.
A ZOSYN CEP of the European Pharmacopoeia monograph is often referred to as a ZOSYN Certificate of Suitability (COS). The purpose of a ZOSYN CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of ZOSYN EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of ZOSYN to their clients by showing that a ZOSYN CEP has been issued for it. The manufacturer submits a ZOSYN CEP (COS) as part of the market authorization procedure, and it takes on the role of a ZOSYN CEP holder for the record. Additionally, the data presented in the ZOSYN CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the ZOSYN DMF.
A ZOSYN CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. ZOSYN 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 ZOSYN suppliers with CEP (COS) on PharmaCompass.
A ZOSYN written confirmation (ZOSYN WC) is an official document issued by a regulatory agency to a ZOSYN manufacturer, verifying that the manufacturing facility of a ZOSYN active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting ZOSYN APIs or ZOSYN finished pharmaceutical products to another nation, regulatory agencies frequently require a ZOSYN WC (written confirmation) as part of the regulatory process.
click here to find a list of ZOSYN 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 ZOSYN as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for ZOSYN 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 ZOSYN 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 ZOSYN and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a ZOSYN NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of ZOSYN suppliers with NDC on PharmaCompass.
ZOSYN 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 ZOSYN 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 ZOSYN GMP manufacturer or ZOSYN GMP API supplier for your needs.
A ZOSYN CoA (Certificate of Analysis) is a formal document that attests to ZOSYN's compliance with ZOSYN specifications and serves as a tool for batch-level quality control.
ZOSYN CoA mostly includes findings from lab analyses of a specific batch. For each ZOSYN 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.
ZOSYN may be tested according to a variety of international standards, such as European Pharmacopoeia (ZOSYN EP), ZOSYN JP (Japanese Pharmacopeia) and the US Pharmacopoeia (ZOSYN USP).
