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API SUPPLIERS
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USDMF
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13741
Submission : 1998-09-01
Status :
Type : II
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HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
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DOSAGE - SOLUTION;INTRAVENOUS - EQ 1GM BASE/5...DOSAGE - SOLUTION;INTRAVENOUS - EQ 1GM BASE/50ML (EQ 20MG BASE/ML)
USFDA APPLICATION NUMBER - 207131
DOSAGE - SOLUTION;INTRAVENOUS - EQ 2GM BASE/1...DOSAGE - SOLUTION;INTRAVENOUS - EQ 2GM BASE/100ML (EQ 20MG BASE/ML)
USFDA APPLICATION NUMBER - 207131
DOSAGE - SOLUTION;INTRAVENOUS - EQ 3GM BASE/1...DOSAGE - SOLUTION;INTRAVENOUS - EQ 3GM BASE/150ML (EQ 20MG BASE/ML)
USFDA APPLICATION NUMBER - 207131
DOSAGE - INJECTABLE;INJECTION - EQ 1GM BASE/V...DOSAGE - INJECTABLE;INJECTION - EQ 1GM BASE/VIAL
USFDA APPLICATION NUMBER - 50779
DOSAGE - INJECTABLE;INJECTION - EQ 2GM BASE/V...DOSAGE - INJECTABLE;INJECTION - EQ 2GM BASE/VIAL
USFDA APPLICATION NUMBER - 50779
DOSAGE - INJECTABLE;INJECTION - EQ 3GM BASE/V...DOSAGE - INJECTABLE;INJECTION - EQ 3GM BASE/VIAL
USFDA APPLICATION NUMBER - 50779
Related Excipient Companies
SPI Pharma
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Cefazolin 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 Cefazolin Sodium manufacturer or Cefazolin Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cefazolin Sodium manufacturer or Cefazolin Sodium supplier.
PharmaCompass also assists you with knowing the Cefazolin Sodium API Price utilized in the formulation of products. Cefazolin Sodium API Price is not always fixed or binding as the Cefazolin Sodium Price is obtained through a variety of data sources. The Cefazolin Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A CEFAZOLIN AND DEXTROSE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CEFAZOLIN AND DEXTROSE, including repackagers and relabelers. The FDA regulates CEFAZOLIN AND DEXTROSE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CEFAZOLIN AND DEXTROSE 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 CEFAZOLIN AND DEXTROSE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A CEFAZOLIN AND DEXTROSE supplier is an individual or a company that provides CEFAZOLIN AND DEXTROSE active pharmaceutical ingredient (API) or CEFAZOLIN AND DEXTROSE finished formulations upon request. The CEFAZOLIN AND DEXTROSE suppliers may include CEFAZOLIN AND DEXTROSE API manufacturers, exporters, distributors and traders.
click here to find a list of CEFAZOLIN AND DEXTROSE suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A CEFAZOLIN AND DEXTROSE DMF (Drug Master File) is a document detailing the whole manufacturing process of CEFAZOLIN AND DEXTROSE active pharmaceutical ingredient (API) in detail. Different forms of CEFAZOLIN AND DEXTROSE DMFs exist exist since differing nations have different regulations, such as CEFAZOLIN AND DEXTROSE USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A CEFAZOLIN AND DEXTROSE DMF submitted to regulatory agencies in the US is known as a USDMF. CEFAZOLIN AND DEXTROSE USDMF includes data on CEFAZOLIN AND DEXTROSE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The CEFAZOLIN AND DEXTROSE USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of CEFAZOLIN AND DEXTROSE 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 CEFAZOLIN AND DEXTROSE Drug Master File in Japan (CEFAZOLIN AND DEXTROSE JDMF) empowers CEFAZOLIN AND DEXTROSE 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 CEFAZOLIN AND DEXTROSE JDMF during the approval evaluation for pharmaceutical products. At the time of CEFAZOLIN AND DEXTROSE 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 CEFAZOLIN AND DEXTROSE 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 CEFAZOLIN AND DEXTROSE Drug Master File in Korea (CEFAZOLIN AND DEXTROSE KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of CEFAZOLIN AND DEXTROSE. The MFDS reviews the CEFAZOLIN AND DEXTROSE KDMF as part of the drug registration process and uses the information provided in the CEFAZOLIN AND DEXTROSE KDMF to evaluate the safety and efficacy of the drug.
After submitting a CEFAZOLIN AND DEXTROSE 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 CEFAZOLIN AND DEXTROSE API can apply through the Korea Drug Master File (KDMF).
click here to find a list of CEFAZOLIN AND DEXTROSE suppliers with KDMF on PharmaCompass.
A CEFAZOLIN AND DEXTROSE CEP of the European Pharmacopoeia monograph is often referred to as a CEFAZOLIN AND DEXTROSE Certificate of Suitability (COS). The purpose of a CEFAZOLIN AND DEXTROSE CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of CEFAZOLIN AND DEXTROSE EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of CEFAZOLIN AND DEXTROSE to their clients by showing that a CEFAZOLIN AND DEXTROSE CEP has been issued for it. The manufacturer submits a CEFAZOLIN AND DEXTROSE CEP (COS) as part of the market authorization procedure, and it takes on the role of a CEFAZOLIN AND DEXTROSE CEP holder for the record. Additionally, the data presented in the CEFAZOLIN AND DEXTROSE CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the CEFAZOLIN AND DEXTROSE DMF.
A CEFAZOLIN AND DEXTROSE CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. CEFAZOLIN AND DEXTROSE 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 CEFAZOLIN AND DEXTROSE suppliers with CEP (COS) on PharmaCompass.
A CEFAZOLIN AND DEXTROSE written confirmation (CEFAZOLIN AND DEXTROSE WC) is an official document issued by a regulatory agency to a CEFAZOLIN AND DEXTROSE manufacturer, verifying that the manufacturing facility of a CEFAZOLIN AND DEXTROSE active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting CEFAZOLIN AND DEXTROSE APIs or CEFAZOLIN AND DEXTROSE finished pharmaceutical products to another nation, regulatory agencies frequently require a CEFAZOLIN AND DEXTROSE WC (written confirmation) as part of the regulatory process.
click here to find a list of CEFAZOLIN AND DEXTROSE 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 CEFAZOLIN AND DEXTROSE as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for CEFAZOLIN AND DEXTROSE 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 CEFAZOLIN AND DEXTROSE 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 CEFAZOLIN AND DEXTROSE and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a CEFAZOLIN AND DEXTROSE NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of CEFAZOLIN AND DEXTROSE suppliers with NDC on PharmaCompass.
CEFAZOLIN AND DEXTROSE 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 CEFAZOLIN AND DEXTROSE 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 CEFAZOLIN AND DEXTROSE GMP manufacturer or CEFAZOLIN AND DEXTROSE GMP API supplier for your needs.
A CEFAZOLIN AND DEXTROSE CoA (Certificate of Analysis) is a formal document that attests to CEFAZOLIN AND DEXTROSE's compliance with CEFAZOLIN AND DEXTROSE specifications and serves as a tool for batch-level quality control.
CEFAZOLIN AND DEXTROSE CoA mostly includes findings from lab analyses of a specific batch. For each CEFAZOLIN AND DEXTROSE 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.
CEFAZOLIN AND DEXTROSE may be tested according to a variety of international standards, such as European Pharmacopoeia (CEFAZOLIN AND DEXTROSE EP), CEFAZOLIN AND DEXTROSE JP (Japanese Pharmacopeia) and the US Pharmacopoeia (CEFAZOLIN AND DEXTROSE USP).
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