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USDMF
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API SUPPLIERS
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INTERMEDIATE SUPPLIERS
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
Faran Shimi Pharmaceutical
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ABOUT THIS PAGE
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PharmaCompass offers a list of Ceftolozane Sulfate 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 Ceftolozane Sulfate manufacturer or Ceftolozane Sulfate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ceftolozane Sulfate manufacturer or Ceftolozane Sulfate supplier.
PharmaCompass also assists you with knowing the Ceftolozane Sulfate API Price utilized in the formulation of products. Ceftolozane Sulfate API Price is not always fixed or binding as the Ceftolozane Sulfate Price is obtained through a variety of data sources. The Ceftolozane Sulfate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A ZERBAXA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ZERBAXA, including repackagers and relabelers. The FDA regulates ZERBAXA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ZERBAXA 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 ZERBAXA manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A ZERBAXA supplier is an individual or a company that provides ZERBAXA active pharmaceutical ingredient (API) or ZERBAXA finished formulations upon request. The ZERBAXA suppliers may include ZERBAXA API manufacturers, exporters, distributors and traders.
click here to find a list of ZERBAXA suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 ZERBAXA Drug Master File in Korea (ZERBAXA KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of ZERBAXA. The MFDS reviews the ZERBAXA KDMF as part of the drug registration process and uses the information provided in the ZERBAXA KDMF to evaluate the safety and efficacy of the drug.
After submitting a ZERBAXA 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 ZERBAXA API can apply through the Korea Drug Master File (KDMF).
click here to find a list of ZERBAXA suppliers with KDMF 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 ZERBAXA as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for ZERBAXA 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 ZERBAXA 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 ZERBAXA and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a ZERBAXA NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of ZERBAXA suppliers with NDC on PharmaCompass.
ZERBAXA 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 ZERBAXA 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 ZERBAXA GMP manufacturer or ZERBAXA GMP API supplier for your needs.
A ZERBAXA CoA (Certificate of Analysis) is a formal document that attests to ZERBAXA's compliance with ZERBAXA specifications and serves as a tool for batch-level quality control.
ZERBAXA CoA mostly includes findings from lab analyses of a specific batch. For each ZERBAXA 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.
ZERBAXA may be tested according to a variety of international standards, such as European Pharmacopoeia (ZERBAXA EP), ZERBAXA JP (Japanese Pharmacopeia) and the US Pharmacopoeia (ZERBAXA USP).
