US DMFs Filed
USA (Orange Book)
PharmaCompass offers a list of Sitagliptin Phosphate 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 Sitagliptin Phosphate manufacturer or Sitagliptin Phosphate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sitagliptin Phosphate manufacturer or Sitagliptin Phosphate supplier.
PharmaCompass also assists you with knowing the Sitagliptin Phosphate API Price utilized in the formulation of products. Sitagliptin Phosphate API Price is not always fixed or binding as the Sitagliptin Phosphate Price is obtained through a variety of data sources. The Sitagliptin Phosphate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Sitagliptin Phosphate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sitagliptin Phosphate, including repackagers and relabelers. The FDA regulates Sitagliptin Phosphate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sitagliptin Phosphate 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 Sitagliptin Phosphate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sitagliptin Phosphate supplier is an individual or a company that provides Sitagliptin Phosphate active pharmaceutical ingredient (API) or Sitagliptin Phosphate finished formulations upon request. The Sitagliptin Phosphate suppliers may include Sitagliptin Phosphate API manufacturers, exporters, distributors and traders.
CLICK HERE to find a list of Sitagliptin Phosphate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sitagliptin Phosphate DMF (Drug Master File) is a document detailing the whole manufacturing process of Sitagliptin Phosphate active pharmaceutical ingredient (API) in detail. Different forms of Sitagliptin Phosphate DMFs exist exist since differing nations have different regulations, such as Sitagliptin Phosphate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sitagliptin Phosphate DMF submitted to regulatory agencies in the US is known as a USDMF. Sitagliptin Phosphate USDMF includes data on Sitagliptin Phosphate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sitagliptin Phosphate USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 Sitagliptin Phosphate Drug Master File in Japan (Sitagliptin Phosphate JDMF) empowers Sitagliptin Phosphate 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 Sitagliptin Phosphate JDMF during the approval evaluation for pharmaceutical products. At the time of Sitagliptin Phosphate JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Sitagliptin Phosphate Drug Master File in Korea (Sitagliptin Phosphate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Sitagliptin Phosphate. The MFDS reviews the Sitagliptin Phosphate KDMF as part of the drug registration process and uses the information provided in the Sitagliptin Phosphate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Sitagliptin Phosphate 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 Sitagliptin Phosphate API can apply through the Korea Drug Master File (KDMF).
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A Sitagliptin Phosphate CEP of the European Pharmacopoeia monograph is often referred to as a Sitagliptin Phosphate Certificate of Suitability (COS). The purpose of a Sitagliptin Phosphate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Sitagliptin Phosphate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Sitagliptin Phosphate to their clients by showing that a Sitagliptin Phosphate CEP has been issued for it. The manufacturer submits a Sitagliptin Phosphate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Sitagliptin Phosphate CEP holder for the record. Additionally, the data presented in the Sitagliptin Phosphate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Sitagliptin Phosphate DMF.
A Sitagliptin Phosphate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Sitagliptin Phosphate CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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A Sitagliptin Phosphate written confirmation (Sitagliptin Phosphate WC) is an official document issued by a regulatory agency to a Sitagliptin Phosphate manufacturer, verifying that the manufacturing facility of a Sitagliptin Phosphate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sitagliptin Phosphate APIs or Sitagliptin Phosphate finished pharmaceutical products to another nation, regulatory agencies frequently require a Sitagliptin Phosphate WC (written confirmation) as part of the regulatory process.
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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 Sitagliptin Phosphate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sitagliptin Phosphate 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 Sitagliptin Phosphate 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 Sitagliptin Phosphate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sitagliptin Phosphate NDC to their finished compounded human drug products, they may choose to do so.
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Sitagliptin Phosphate 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 Sitagliptin Phosphate 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 Sitagliptin Phosphate GMP manufacturer or Sitagliptin Phosphate GMP API supplier for your needs.
A Sitagliptin Phosphate CoA (Certificate of Analysis) is a formal document that attests to Sitagliptin Phosphate's compliance with Sitagliptin Phosphate specifications and serves as a tool for batch-level quality control.
Sitagliptin Phosphate CoA mostly includes findings from lab analyses of a specific batch. For each Sitagliptin Phosphate 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.
Sitagliptin Phosphate may be tested according to a variety of international standards, such as European Pharmacopoeia (Sitagliptin Phosphate EP), Sitagliptin Phosphate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sitagliptin Phosphate USP).