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API SUPPLIERS
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USDMF
TAPI offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16751
Submission : 2003-08-08
Status :
Type : II
TAPI offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-24
Pay. Date : 2012-12-03
DMF Number : 19342
Submission : 2006-04-11
Status :
Type : II
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Drugs in Development
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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
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Faran Shimi Pharmaceutical
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Aztreonam manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Aztreonam, including repackagers and relabelers. The FDA regulates Aztreonam manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Aztreonam 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 Aztreonam manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Aztreonam supplier is an individual or a company that provides Aztreonam active pharmaceutical ingredient (API) or Aztreonam finished formulations upon request. The Aztreonam suppliers may include Aztreonam API manufacturers, exporters, distributors and traders.
click here to find a list of Aztreonam suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Aztreonam DMF (Drug Master File) is a document detailing the whole manufacturing process of Aztreonam active pharmaceutical ingredient (API) in detail. Different forms of Aztreonam DMFs exist exist since differing nations have different regulations, such as Aztreonam USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Aztreonam DMF submitted to regulatory agencies in the US is known as a USDMF. Aztreonam USDMF includes data on Aztreonam's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Aztreonam USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Aztreonam 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 Aztreonam Drug Master File in Japan (Aztreonam JDMF) empowers Aztreonam 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 Aztreonam JDMF during the approval evaluation for pharmaceutical products. At the time of Aztreonam 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 Aztreonam suppliers with JDMF 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 Aztreonam as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Aztreonam 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 Aztreonam 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 Aztreonam and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Aztreonam NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Aztreonam suppliers with NDC on PharmaCompass.
Aztreonam 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 Aztreonam 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 Aztreonam GMP manufacturer or Aztreonam GMP API supplier for your needs.
A Aztreonam CoA (Certificate of Analysis) is a formal document that attests to Aztreonam's compliance with Aztreonam specifications and serves as a tool for batch-level quality control.
Aztreonam CoA mostly includes findings from lab analyses of a specific batch. For each Aztreonam 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.
Aztreonam may be tested according to a variety of international standards, such as European Pharmacopoeia (Aztreonam EP), Aztreonam JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Aztreonam USP).
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