Synopsis
0
VMF
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
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]DRUG PRODUCT COMPOSITIONS
DOSAGE - TABLET;ORAL - EQ 100MG BASE
USFDA APPLICATION NUMBER - 21995
DOSAGE - TABLET;ORAL - EQ 25MG BASE
USFDA APPLICATION NUMBER - 21995
DOSAGE - TABLET;ORAL - EQ 50MG BASE
USFDA APPLICATION NUMBER - 21995
DOSAGE - TABLET;ORAL - 1GM;EQ 50MG BASE
USFDA APPLICATION NUMBER - 22044
DOSAGE - TABLET;ORAL - 500MG;EQ 50MG BASE
USFDA APPLICATION NUMBER - 22044
Related Excipient Companies
Minakem
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lonza Capsugel
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Novo Excipients
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharmatrans-Sanaq
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Coating Systems & Additives
Fillers, Diluents & Binders
Controlled & Modified Release
Lubricants & Glidants
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Granulation
Topical
Direct Compression
Co-Processed Excipients
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Solubilizers
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Emulsifying Agents
Vegetarian Capsules
Rheology Modifiers
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Parenteral
Digital Content
DATA COMPILATION #PharmaFlow
WEEKLY NEWS RECAP #Phispers
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
ABOUT THIS PAGE
92
PharmaCompass offers a list of Sitagliptin Phosphate 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 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.
A SITAGLIPTIN PHOSPHATE SALT manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of SITAGLIPTIN PHOSPHATE SALT, including repackagers and relabelers. The FDA regulates SITAGLIPTIN PHOSPHATE SALT manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. SITAGLIPTIN PHOSPHATE SALT 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 SALT manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A SITAGLIPTIN PHOSPHATE SALT supplier is an individual or a company that provides SITAGLIPTIN PHOSPHATE SALT active pharmaceutical ingredient (API) or SITAGLIPTIN PHOSPHATE SALT finished formulations upon request. The SITAGLIPTIN PHOSPHATE SALT suppliers may include SITAGLIPTIN PHOSPHATE SALT API manufacturers, exporters, distributors and traders.
click here to find a list of SITAGLIPTIN PHOSPHATE SALT suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A SITAGLIPTIN PHOSPHATE SALT DMF (Drug Master File) is a document detailing the whole manufacturing process of SITAGLIPTIN PHOSPHATE SALT active pharmaceutical ingredient (API) in detail. Different forms of SITAGLIPTIN PHOSPHATE SALT DMFs exist exist since differing nations have different regulations, such as SITAGLIPTIN PHOSPHATE SALT USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A SITAGLIPTIN PHOSPHATE SALT DMF submitted to regulatory agencies in the US is known as a USDMF. SITAGLIPTIN PHOSPHATE SALT USDMF includes data on SITAGLIPTIN PHOSPHATE SALT's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The SITAGLIPTIN PHOSPHATE SALT USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of SITAGLIPTIN PHOSPHATE SALT 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 SITAGLIPTIN PHOSPHATE SALT Drug Master File in Japan (SITAGLIPTIN PHOSPHATE SALT JDMF) empowers SITAGLIPTIN PHOSPHATE SALT 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 SALT JDMF during the approval evaluation for pharmaceutical products. At the time of SITAGLIPTIN PHOSPHATE SALT 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 SITAGLIPTIN PHOSPHATE SALT 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 SITAGLIPTIN PHOSPHATE SALT Drug Master File in Korea (SITAGLIPTIN PHOSPHATE SALT KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of SITAGLIPTIN PHOSPHATE SALT. The MFDS reviews the SITAGLIPTIN PHOSPHATE SALT KDMF as part of the drug registration process and uses the information provided in the SITAGLIPTIN PHOSPHATE SALT KDMF to evaluate the safety and efficacy of the drug.
After submitting a SITAGLIPTIN PHOSPHATE SALT 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 SALT API can apply through the Korea Drug Master File (KDMF).
click here to find a list of SITAGLIPTIN PHOSPHATE SALT suppliers with KDMF on PharmaCompass.
A SITAGLIPTIN PHOSPHATE SALT CEP of the European Pharmacopoeia monograph is often referred to as a SITAGLIPTIN PHOSPHATE SALT Certificate of Suitability (COS). The purpose of a SITAGLIPTIN PHOSPHATE SALT CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of SITAGLIPTIN PHOSPHATE SALT EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of SITAGLIPTIN PHOSPHATE SALT to their clients by showing that a SITAGLIPTIN PHOSPHATE SALT CEP has been issued for it. The manufacturer submits a SITAGLIPTIN PHOSPHATE SALT CEP (COS) as part of the market authorization procedure, and it takes on the role of a SITAGLIPTIN PHOSPHATE SALT CEP holder for the record. Additionally, the data presented in the SITAGLIPTIN PHOSPHATE SALT CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the SITAGLIPTIN PHOSPHATE SALT DMF.
A SITAGLIPTIN PHOSPHATE SALT CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. SITAGLIPTIN PHOSPHATE SALT 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 SITAGLIPTIN PHOSPHATE SALT suppliers with CEP (COS) on PharmaCompass.
A SITAGLIPTIN PHOSPHATE SALT written confirmation (SITAGLIPTIN PHOSPHATE SALT WC) is an official document issued by a regulatory agency to a SITAGLIPTIN PHOSPHATE SALT manufacturer, verifying that the manufacturing facility of a SITAGLIPTIN PHOSPHATE SALT active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting SITAGLIPTIN PHOSPHATE SALT APIs or SITAGLIPTIN PHOSPHATE SALT finished pharmaceutical products to another nation, regulatory agencies frequently require a SITAGLIPTIN PHOSPHATE SALT WC (written confirmation) as part of the regulatory process.
click here to find a list of SITAGLIPTIN PHOSPHATE SALT 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 SITAGLIPTIN PHOSPHATE SALT as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for SITAGLIPTIN PHOSPHATE SALT 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 SALT 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 SALT and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a SITAGLIPTIN PHOSPHATE SALT NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of SITAGLIPTIN PHOSPHATE SALT suppliers with NDC on PharmaCompass.
SITAGLIPTIN PHOSPHATE SALT 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 SALT GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right SITAGLIPTIN PHOSPHATE SALT GMP manufacturer or SITAGLIPTIN PHOSPHATE SALT GMP API supplier for your needs.
A SITAGLIPTIN PHOSPHATE SALT CoA (Certificate of Analysis) is a formal document that attests to SITAGLIPTIN PHOSPHATE SALT's compliance with SITAGLIPTIN PHOSPHATE SALT specifications and serves as a tool for batch-level quality control.
SITAGLIPTIN PHOSPHATE SALT CoA mostly includes findings from lab analyses of a specific batch. For each SITAGLIPTIN PHOSPHATE SALT 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 SALT may be tested according to a variety of international standards, such as European Pharmacopoeia (SITAGLIPTIN PHOSPHATE SALT EP), SITAGLIPTIN PHOSPHATE SALT JP (Japanese Pharmacopeia) and the US Pharmacopoeia (SITAGLIPTIN PHOSPHATE SALT USP).
