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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- EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
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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 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.
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 PIPERACILLIN; TAZOBACTAM Drug Master File in Japan (PIPERACILLIN; TAZOBACTAM JDMF) empowers PIPERACILLIN; TAZOBACTAM 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 PIPERACILLIN; TAZOBACTAM JDMF during the approval evaluation for pharmaceutical products. At the time of PIPERACILLIN; TAZOBACTAM 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 PIPERACILLIN; TAZOBACTAM 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 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 CEP of the European Pharmacopoeia monograph is often referred to as a PIPERACILLIN; TAZOBACTAM Certificate of Suitability (COS). The purpose of a PIPERACILLIN; TAZOBACTAM CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of PIPERACILLIN; TAZOBACTAM EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of PIPERACILLIN; TAZOBACTAM to their clients by showing that a PIPERACILLIN; TAZOBACTAM CEP has been issued for it. The manufacturer submits a PIPERACILLIN; TAZOBACTAM CEP (COS) as part of the market authorization procedure, and it takes on the role of a PIPERACILLIN; TAZOBACTAM CEP holder for the record. Additionally, the data presented in the PIPERACILLIN; TAZOBACTAM CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the PIPERACILLIN; TAZOBACTAM DMF.
A PIPERACILLIN; TAZOBACTAM CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. PIPERACILLIN; TAZOBACTAM 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 PIPERACILLIN; TAZOBACTAM suppliers with CEP (COS) 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).
