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API SUPPLIERS
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USDMF
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Drugs in Development
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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
Related Excipient Companies
Rochem International Inc
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
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ABOUT THIS PAGE
A Alogliptin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alogliptin, including repackagers and relabelers. The FDA regulates Alogliptin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alogliptin 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Alogliptin supplier is an individual or a company that provides Alogliptin active pharmaceutical ingredient (API) or Alogliptin finished formulations upon request. The Alogliptin suppliers may include Alogliptin API manufacturers, exporters, distributors and traders.
click here to find a list of Alogliptin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Alogliptin DMF (Drug Master File) is a document detailing the whole manufacturing process of Alogliptin active pharmaceutical ingredient (API) in detail. Different forms of Alogliptin DMFs exist exist since differing nations have different regulations, such as Alogliptin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Alogliptin DMF submitted to regulatory agencies in the US is known as a USDMF. Alogliptin USDMF includes data on Alogliptin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Alogliptin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Alogliptin 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 Drug Master File in Japan (Alogliptin JDMF) empowers Alogliptin 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 JDMF during the approval evaluation for pharmaceutical products. At the time of Alogliptin 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 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 Drug Master File in Korea (Alogliptin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Alogliptin. The MFDS reviews the Alogliptin KDMF as part of the drug registration process and uses the information provided in the Alogliptin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Alogliptin 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 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Alogliptin suppliers with KDMF on PharmaCompass.
A Alogliptin written confirmation (Alogliptin WC) is an official document issued by a regulatory agency to a Alogliptin manufacturer, verifying that the manufacturing facility of a Alogliptin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Alogliptin APIs or Alogliptin finished pharmaceutical products to another nation, regulatory agencies frequently require a Alogliptin WC (written confirmation) as part of the regulatory process.
click here to find a list of Alogliptin 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 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Alogliptin 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 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 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Alogliptin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Alogliptin suppliers with NDC on PharmaCompass.
Alogliptin 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 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 Alogliptin GMP manufacturer or Alogliptin GMP API supplier for your needs.
A Alogliptin CoA (Certificate of Analysis) is a formal document that attests to Alogliptin's compliance with Alogliptin specifications and serves as a tool for batch-level quality control.
Alogliptin CoA mostly includes findings from lab analyses of a specific batch. For each Alogliptin 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Alogliptin EP), Alogliptin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Alogliptin USP).
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