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API SUPPLIERS
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USDMF
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DOSAGE - CREAM;VAGINAL - 0.4% **Federal Regis...DOSAGE - CREAM;VAGINAL - 0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19579
DOSAGE - SUPPOSITORY;VAGINAL - 80MG **Federal...DOSAGE - SUPPOSITORY;VAGINAL - 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19641
DOSAGE - CREAM;VAGINAL - 0.8% **Federal Regis...DOSAGE - CREAM;VAGINAL - 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19964
DOSAGE - CREAM;VAGINAL - 0.8%
USFDA APPLICATION NUMBER - 21735
Related Excipient Companies
Nanjing Well Pharmaceutical
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Terconazole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Terconazole, including repackagers and relabelers. The FDA regulates Terconazole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Terconazole 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 Terconazole manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Terconazole supplier is an individual or a company that provides Terconazole active pharmaceutical ingredient (API) or Terconazole finished formulations upon request. The Terconazole suppliers may include Terconazole API manufacturers, exporters, distributors and traders.
click here to find a list of Terconazole suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Terconazole DMF (Drug Master File) is a document detailing the whole manufacturing process of Terconazole active pharmaceutical ingredient (API) in detail. Different forms of Terconazole DMFs exist exist since differing nations have different regulations, such as Terconazole USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Terconazole DMF submitted to regulatory agencies in the US is known as a USDMF. Terconazole USDMF includes data on Terconazole's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Terconazole USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Terconazole suppliers with USDMF on PharmaCompass.
A Terconazole CEP of the European Pharmacopoeia monograph is often referred to as a Terconazole Certificate of Suitability (COS). The purpose of a Terconazole CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Terconazole EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Terconazole to their clients by showing that a Terconazole CEP has been issued for it. The manufacturer submits a Terconazole CEP (COS) as part of the market authorization procedure, and it takes on the role of a Terconazole CEP holder for the record. Additionally, the data presented in the Terconazole CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Terconazole DMF.
A Terconazole CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Terconazole 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 Terconazole suppliers with CEP (COS) on PharmaCompass.
A Terconazole written confirmation (Terconazole WC) is an official document issued by a regulatory agency to a Terconazole manufacturer, verifying that the manufacturing facility of a Terconazole active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Terconazole APIs or Terconazole finished pharmaceutical products to another nation, regulatory agencies frequently require a Terconazole WC (written confirmation) as part of the regulatory process.
click here to find a list of Terconazole 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 Terconazole as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Terconazole 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 Terconazole 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 Terconazole and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Terconazole NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Terconazole suppliers with NDC on PharmaCompass.
Terconazole 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 Terconazole 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 Terconazole GMP manufacturer or Terconazole GMP API supplier for your needs.
A Terconazole CoA (Certificate of Analysis) is a formal document that attests to Terconazole's compliance with Terconazole specifications and serves as a tool for batch-level quality control.
Terconazole CoA mostly includes findings from lab analyses of a specific batch. For each Terconazole 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.
Terconazole may be tested according to a variety of international standards, such as European Pharmacopoeia (Terconazole EP), Terconazole JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Terconazole USP).
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