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API SUPPLIERS
Century has been an API manufacturer for over 40 years & is the partner of choice for multipurpose custom manufacturing projects.
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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Lupin Manufacturing Solutions – delivering high-quality APIs & end-to-end CDMO services for faster, cost-effective drug development.
Willow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.
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USDMF
Century has been an API manufacturer for over 40 years & is the partner of choice for multipurpose custom manufacturing projects.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34583
Submission : 2020-03-09
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2015-01-13
Pay. Date : 2014-04-25
DMF Number : 15972
Submission : 2002-05-02
Status :
Type : II
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ABOUT THIS PAGE
47
PharmaCompass offers a list of Azithromycin Dihydrate 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 Azithromycin Dihydrate manufacturer or Azithromycin Dihydrate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Azithromycin Dihydrate manufacturer or Azithromycin Dihydrate supplier.
A Azitral manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Azitral, including repackagers and relabelers. The FDA regulates Azitral manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Azitral 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 Azitral manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Azitral supplier is an individual or a company that provides Azitral active pharmaceutical ingredient (API) or Azitral finished formulations upon request. The Azitral suppliers may include Azitral API manufacturers, exporters, distributors and traders.
click here to find a list of Azitral suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Azitral DMF (Drug Master File) is a document detailing the whole manufacturing process of Azitral active pharmaceutical ingredient (API) in detail. Different forms of Azitral DMFs exist exist since differing nations have different regulations, such as Azitral USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Azitral DMF submitted to regulatory agencies in the US is known as a USDMF. Azitral USDMF includes data on Azitral's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Azitral USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Azitral 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 Azitral Drug Master File in Japan (Azitral JDMF) empowers Azitral 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 Azitral JDMF during the approval evaluation for pharmaceutical products. At the time of Azitral 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 Azitral suppliers with JDMF on PharmaCompass.
A Azitral CEP of the European Pharmacopoeia monograph is often referred to as a Azitral Certificate of Suitability (COS). The purpose of a Azitral CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Azitral EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Azitral to their clients by showing that a Azitral CEP has been issued for it. The manufacturer submits a Azitral CEP (COS) as part of the market authorization procedure, and it takes on the role of a Azitral CEP holder for the record. Additionally, the data presented in the Azitral CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Azitral DMF.
A Azitral CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Azitral 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 Azitral suppliers with CEP (COS) on PharmaCompass.
A Azitral written confirmation (Azitral WC) is an official document issued by a regulatory agency to a Azitral manufacturer, verifying that the manufacturing facility of a Azitral active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Azitral APIs or Azitral finished pharmaceutical products to another nation, regulatory agencies frequently require a Azitral WC (written confirmation) as part of the regulatory process.
click here to find a list of Azitral 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 Azitral as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Azitral 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 Azitral 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 Azitral and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Azitral NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Azitral suppliers with NDC on PharmaCompass.
Azitral 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 Azitral GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Azitral GMP manufacturer or Azitral GMP API supplier for your needs.
A Azitral CoA (Certificate of Analysis) is a formal document that attests to Azitral's compliance with Azitral specifications and serves as a tool for batch-level quality control.
Azitral CoA mostly includes findings from lab analyses of a specific batch. For each Azitral 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.
Azitral may be tested according to a variety of international standards, such as European Pharmacopoeia (Azitral EP), Azitral JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Azitral USP).
