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DRUG PRODUCT COMPOSITIONS
API SUPPLIERS
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USDMF
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DOSAGE - INJECTABLE;INJECTION - 1GM/VIAL
USFDA APPLICATION NUMBER - 50580
DOSAGE - INJECTABLE;INJECTION - 2GM/VIAL
USFDA APPLICATION NUMBER - 50580
DOSAGE - INJECTABLE;INJECTION - 20MG/ML
USFDA APPLICATION NUMBER - 50632
DOSAGE - INJECTABLE;INJECTION - 40MG/ML
USFDA APPLICATION NUMBER - 50632
Related Excipient Companies
Pfanstiehl
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Fillers, Diluents & Binders
Thickeners and Stabilizers
API Stability Enhancers
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
Dosage Form : Injectable / Parenteral
Grade : Parenteral
Application : Parenteral, Thickeners and Stabilizers
Excipient Details : L-Arginine is used as a cryoprotective agent and solution additive to stabilize proteins. It is used in injectable biologic & vaccine formulations.
Pharmacopoeia Ref : USP, EP, JP, ChP
Technical Specs : Low Endotoxin, Low Metals
Ingredient(s) : L-Arginine Excipient
High-quality raw materials and custom blends for pharma, biopharma, nutrition, veterinary, and cosmetics worldwide.
Dosage Form : Injectable / Parenteral
Grade : Biopharma Grade
Application : API Stability Enhancers, Thickeners and Stabilizers
Excipient Details : Used to stabilize proteins in injectable biologic formulations. Also used as a nutrient for cell culture media in upstream.
Pharmacopoeia Ref : On Request
Technical Specs : Low bacteria endotoxins, low bioburden (TAMC/TYMC). Customised pa...
Ingredient(s) : L-Arginine Excipient
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Aztreonam API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Aztreonam manufacturer or Aztreonam supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Aztreonam manufacturer or Aztreonam supplier.
A Azactam manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Azactam, including repackagers and relabelers. The FDA regulates Azactam manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Azactam 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 Azactam manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Azactam supplier is an individual or a company that provides Azactam active pharmaceutical ingredient (API) or Azactam finished formulations upon request. The Azactam suppliers may include Azactam API manufacturers, exporters, distributors and traders.
click here to find a list of Azactam suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Azactam DMF (Drug Master File) is a document detailing the whole manufacturing process of Azactam active pharmaceutical ingredient (API) in detail. Different forms of Azactam DMFs exist exist since differing nations have different regulations, such as Azactam USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Azactam DMF submitted to regulatory agencies in the US is known as a USDMF. Azactam USDMF includes data on Azactam's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Azactam USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Azactam 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 Azactam Drug Master File in Japan (Azactam JDMF) empowers Azactam 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 Azactam JDMF during the approval evaluation for pharmaceutical products. At the time of Azactam 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 Azactam 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 Azactam Drug Master File in Korea (Azactam KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Azactam. The MFDS reviews the Azactam KDMF as part of the drug registration process and uses the information provided in the Azactam KDMF to evaluate the safety and efficacy of the drug.
After submitting a Azactam 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 Azactam API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Azactam 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 Azactam as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Azactam 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 Azactam 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 Azactam and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Azactam NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Azactam suppliers with NDC on PharmaCompass.
Azactam 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 Azactam GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Azactam GMP manufacturer or Azactam GMP API supplier for your needs.
A Azactam CoA (Certificate of Analysis) is a formal document that attests to Azactam's compliance with Azactam specifications and serves as a tool for batch-level quality control.
Azactam CoA mostly includes findings from lab analyses of a specific batch. For each Azactam 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.
Azactam may be tested according to a variety of international standards, such as European Pharmacopoeia (Azactam EP), Azactam JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Azactam USP).
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