Synopsis
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CEP/COS
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VMF
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South Africa
DRUG PRODUCT COMPOSITIONS0
FDF
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Stock Recap #PipelineProspector
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API SUPPLIERS
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USDMF
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
Lead Product(s) : Alogliptin Benzoate,Metformin,Aspirin
Therapeutic Area : Endocrinology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Alogliptin is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Diabetes Mellitus, Type 2.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
January 07, 2019
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DOSAGE - TABLET;ORAL - EQ 12.5MG BASE;1GM
USFDA APPLICATION NUMBER - 203414
DOSAGE - TABLET;ORAL - EQ 12.5MG BASE;500MG
USFDA APPLICATION NUMBER - 203414
DOSAGE - TABLET;ORAL - EQ 12.5MG BASE
USFDA APPLICATION NUMBER - 22271
DOSAGE - TABLET;ORAL - EQ 25MG BASE
USFDA APPLICATION NUMBER - 22271
DOSAGE - TABLET;ORAL - EQ 6.25MG BASE
USFDA APPLICATION NUMBER - 22271
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ABOUT THIS PAGE
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PharmaCompass offers a list of Alogliptin Benzoate 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 Alogliptin Benzoate manufacturer or Alogliptin Benzoate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Alogliptin Benzoate manufacturer or Alogliptin Benzoate supplier.
A ALOGLIPTIN BENZOATE COMPONENT OF KAZANO manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ALOGLIPTIN BENZOATE COMPONENT OF KAZANO, including repackagers and relabelers. The FDA regulates ALOGLIPTIN BENZOATE COMPONENT OF KAZANO manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ALOGLIPTIN BENZOATE COMPONENT OF KAZANO 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 ALOGLIPTIN BENZOATE COMPONENT OF KAZANO manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A ALOGLIPTIN BENZOATE COMPONENT OF KAZANO supplier is an individual or a company that provides ALOGLIPTIN BENZOATE COMPONENT OF KAZANO active pharmaceutical ingredient (API) or ALOGLIPTIN BENZOATE COMPONENT OF KAZANO finished formulations upon request. The ALOGLIPTIN BENZOATE COMPONENT OF KAZANO suppliers may include ALOGLIPTIN BENZOATE COMPONENT OF KAZANO API manufacturers, exporters, distributors and traders.
click here to find a list of ALOGLIPTIN BENZOATE COMPONENT OF KAZANO suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A ALOGLIPTIN BENZOATE COMPONENT OF KAZANO DMF (Drug Master File) is a document detailing the whole manufacturing process of ALOGLIPTIN BENZOATE COMPONENT OF KAZANO active pharmaceutical ingredient (API) in detail. Different forms of ALOGLIPTIN BENZOATE COMPONENT OF KAZANO DMFs exist exist since differing nations have different regulations, such as ALOGLIPTIN BENZOATE COMPONENT OF KAZANO USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A ALOGLIPTIN BENZOATE COMPONENT OF KAZANO DMF submitted to regulatory agencies in the US is known as a USDMF. ALOGLIPTIN BENZOATE COMPONENT OF KAZANO USDMF includes data on ALOGLIPTIN BENZOATE COMPONENT OF KAZANO's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The ALOGLIPTIN BENZOATE COMPONENT OF KAZANO USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of ALOGLIPTIN BENZOATE COMPONENT OF KAZANO 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 ALOGLIPTIN BENZOATE COMPONENT OF KAZANO Drug Master File in Japan (ALOGLIPTIN BENZOATE COMPONENT OF KAZANO JDMF) empowers ALOGLIPTIN BENZOATE COMPONENT OF KAZANO 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 ALOGLIPTIN BENZOATE COMPONENT OF KAZANO JDMF during the approval evaluation for pharmaceutical products. At the time of ALOGLIPTIN BENZOATE COMPONENT OF KAZANO 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 ALOGLIPTIN BENZOATE COMPONENT OF KAZANO 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 ALOGLIPTIN BENZOATE COMPONENT OF KAZANO Drug Master File in Korea (ALOGLIPTIN BENZOATE COMPONENT OF KAZANO KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of ALOGLIPTIN BENZOATE COMPONENT OF KAZANO. The MFDS reviews the ALOGLIPTIN BENZOATE COMPONENT OF KAZANO KDMF as part of the drug registration process and uses the information provided in the ALOGLIPTIN BENZOATE COMPONENT OF KAZANO KDMF to evaluate the safety and efficacy of the drug.
After submitting a ALOGLIPTIN BENZOATE COMPONENT OF KAZANO 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 ALOGLIPTIN BENZOATE COMPONENT OF KAZANO API can apply through the Korea Drug Master File (KDMF).
click here to find a list of ALOGLIPTIN BENZOATE COMPONENT OF KAZANO suppliers with KDMF on PharmaCompass.
A ALOGLIPTIN BENZOATE COMPONENT OF KAZANO written confirmation (ALOGLIPTIN BENZOATE COMPONENT OF KAZANO WC) is an official document issued by a regulatory agency to a ALOGLIPTIN BENZOATE COMPONENT OF KAZANO manufacturer, verifying that the manufacturing facility of a ALOGLIPTIN BENZOATE COMPONENT OF KAZANO active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting ALOGLIPTIN BENZOATE COMPONENT OF KAZANO APIs or ALOGLIPTIN BENZOATE COMPONENT OF KAZANO finished pharmaceutical products to another nation, regulatory agencies frequently require a ALOGLIPTIN BENZOATE COMPONENT OF KAZANO WC (written confirmation) as part of the regulatory process.
click here to find a list of ALOGLIPTIN BENZOATE COMPONENT OF KAZANO 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 ALOGLIPTIN BENZOATE COMPONENT OF KAZANO as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for ALOGLIPTIN BENZOATE COMPONENT OF KAZANO 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 ALOGLIPTIN BENZOATE COMPONENT OF KAZANO 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 ALOGLIPTIN BENZOATE COMPONENT OF KAZANO and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a ALOGLIPTIN BENZOATE COMPONENT OF KAZANO NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of ALOGLIPTIN BENZOATE COMPONENT OF KAZANO suppliers with NDC on PharmaCompass.
ALOGLIPTIN BENZOATE COMPONENT OF KAZANO 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 ALOGLIPTIN BENZOATE COMPONENT OF KAZANO GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right ALOGLIPTIN BENZOATE COMPONENT OF KAZANO GMP manufacturer or ALOGLIPTIN BENZOATE COMPONENT OF KAZANO GMP API supplier for your needs.
A ALOGLIPTIN BENZOATE COMPONENT OF KAZANO CoA (Certificate of Analysis) is a formal document that attests to ALOGLIPTIN BENZOATE COMPONENT OF KAZANO's compliance with ALOGLIPTIN BENZOATE COMPONENT OF KAZANO specifications and serves as a tool for batch-level quality control.
ALOGLIPTIN BENZOATE COMPONENT OF KAZANO CoA mostly includes findings from lab analyses of a specific batch. For each ALOGLIPTIN BENZOATE COMPONENT OF KAZANO 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.
ALOGLIPTIN BENZOATE COMPONENT OF KAZANO may be tested according to a variety of international standards, such as European Pharmacopoeia (ALOGLIPTIN BENZOATE COMPONENT OF KAZANO EP), ALOGLIPTIN BENZOATE COMPONENT OF KAZANO JP (Japanese Pharmacopeia) and the US Pharmacopoeia (ALOGLIPTIN BENZOATE COMPONENT OF KAZANO USP).
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