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PharmaCompass offers a list of Anagliptin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Anagliptin manufacturer or Anagliptin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Anagliptin manufacturer or Anagliptin supplier.
PharmaCompass also assists you with knowing the Anagliptin API Price utilized in the formulation of products. Anagliptin API Price is not always fixed or binding as the Anagliptin Price is obtained through a variety of data sources. The Anagliptin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Anagliptin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Anagliptin, including repackagers and relabelers. The FDA regulates Anagliptin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Anagliptin 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 Anagliptin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Anagliptin supplier is an individual or a company that provides Anagliptin active pharmaceutical ingredient (API) or Anagliptin finished formulations upon request. The Anagliptin suppliers may include Anagliptin API manufacturers, exporters, distributors and traders.
click here to find a list of Anagliptin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Anagliptin DMF (Drug Master File) is a document detailing the whole manufacturing process of Anagliptin active pharmaceutical ingredient (API) in detail. Different forms of Anagliptin DMFs exist exist since differing nations have different regulations, such as Anagliptin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Anagliptin DMF submitted to regulatory agencies in the US is known as a USDMF. Anagliptin USDMF includes data on Anagliptin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Anagliptin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Anagliptin 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 Anagliptin Drug Master File in Japan (Anagliptin JDMF) empowers Anagliptin 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 Anagliptin JDMF during the approval evaluation for pharmaceutical products. At the time of Anagliptin 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 Anagliptin 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 Anagliptin Drug Master File in Korea (Anagliptin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Anagliptin. The MFDS reviews the Anagliptin KDMF as part of the drug registration process and uses the information provided in the Anagliptin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Anagliptin 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 Anagliptin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Anagliptin suppliers with KDMF on PharmaCompass.
Anagliptin 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 Anagliptin 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 Anagliptin GMP manufacturer or Anagliptin GMP API supplier for your needs.
A Anagliptin CoA (Certificate of Analysis) is a formal document that attests to Anagliptin's compliance with Anagliptin specifications and serves as a tool for batch-level quality control.
Anagliptin CoA mostly includes findings from lab analyses of a specific batch. For each Anagliptin 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.
Anagliptin may be tested according to a variety of international standards, such as European Pharmacopoeia (Anagliptin EP), Anagliptin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Anagliptin USP).
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