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] EU WC
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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]Dr. Paul Lohmann GmbH & Co. KGaA
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Aeon Procare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Esteem Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ideal Cures
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Keval Exports
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kima Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lonza Capsugel
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Neelkanth MineChem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nitika Pharmaceutical Specialities
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nomisma Healthcare
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Prachin Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qianhao Chemical (Hebei) Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qualicaps
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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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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]The Dow Chemical Company
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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
Thickeners and Stabilizers
Disintegrants & Superdisintegrants
Topical
Granulation
Direct Compression
Co-Processed Excipients
API Stability Enhancers
Solubilizers
Film Formers & Plasticizers
Taste Masking
Chewable & Orodispersible Aids
Empty Capsules
Emulsifying Agents
Vegetarian Capsules
Rheology Modifiers
Coloring Agents
Parenteral
Surfactant & Foaming Agents
Digital Content
DATA COMPILATION #PharmaFlow
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 monophosphate monohydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of sitagliptin monophosphate monohydrate, including repackagers and relabelers. The FDA regulates sitagliptin monophosphate monohydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. sitagliptin monophosphate monohydrate 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 monophosphate monohydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A sitagliptin monophosphate monohydrate supplier is an individual or a company that provides sitagliptin monophosphate monohydrate active pharmaceutical ingredient (API) or sitagliptin monophosphate monohydrate finished formulations upon request. The sitagliptin monophosphate monohydrate suppliers may include sitagliptin monophosphate monohydrate API manufacturers, exporters, distributors and traders.
click here to find a list of sitagliptin monophosphate monohydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A sitagliptin monophosphate monohydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of sitagliptin monophosphate monohydrate active pharmaceutical ingredient (API) in detail. Different forms of sitagliptin monophosphate monohydrate DMFs exist exist since differing nations have different regulations, such as sitagliptin monophosphate monohydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A sitagliptin monophosphate monohydrate DMF submitted to regulatory agencies in the US is known as a USDMF. sitagliptin monophosphate monohydrate USDMF includes data on sitagliptin monophosphate monohydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The sitagliptin monophosphate monohydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of sitagliptin monophosphate monohydrate 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 monophosphate monohydrate Drug Master File in Japan (sitagliptin monophosphate monohydrate JDMF) empowers sitagliptin monophosphate monohydrate 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 monophosphate monohydrate JDMF during the approval evaluation for pharmaceutical products. At the time of sitagliptin monophosphate monohydrate 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 monophosphate monohydrate 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 monophosphate monohydrate Drug Master File in Korea (sitagliptin monophosphate monohydrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of sitagliptin monophosphate monohydrate. The MFDS reviews the sitagliptin monophosphate monohydrate KDMF as part of the drug registration process and uses the information provided in the sitagliptin monophosphate monohydrate KDMF to evaluate the safety and efficacy of the drug.
After submitting a sitagliptin monophosphate monohydrate 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 monophosphate monohydrate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of sitagliptin monophosphate monohydrate suppliers with KDMF on PharmaCompass.
A sitagliptin monophosphate monohydrate CEP of the European Pharmacopoeia monograph is often referred to as a sitagliptin monophosphate monohydrate Certificate of Suitability (COS). The purpose of a sitagliptin monophosphate monohydrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of sitagliptin monophosphate monohydrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of sitagliptin monophosphate monohydrate to their clients by showing that a sitagliptin monophosphate monohydrate CEP has been issued for it. The manufacturer submits a sitagliptin monophosphate monohydrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a sitagliptin monophosphate monohydrate CEP holder for the record. Additionally, the data presented in the sitagliptin monophosphate monohydrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the sitagliptin monophosphate monohydrate DMF.
A sitagliptin monophosphate monohydrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. sitagliptin monophosphate monohydrate 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 monophosphate monohydrate suppliers with CEP (COS) on PharmaCompass.
A sitagliptin monophosphate monohydrate written confirmation (sitagliptin monophosphate monohydrate WC) is an official document issued by a regulatory agency to a sitagliptin monophosphate monohydrate manufacturer, verifying that the manufacturing facility of a sitagliptin monophosphate monohydrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting sitagliptin monophosphate monohydrate APIs or sitagliptin monophosphate monohydrate finished pharmaceutical products to another nation, regulatory agencies frequently require a sitagliptin monophosphate monohydrate WC (written confirmation) as part of the regulatory process.
click here to find a list of sitagliptin monophosphate monohydrate 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 monophosphate monohydrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for sitagliptin monophosphate monohydrate 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 monophosphate monohydrate 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 monophosphate monohydrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a sitagliptin monophosphate monohydrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of sitagliptin monophosphate monohydrate suppliers with NDC on PharmaCompass.
sitagliptin monophosphate monohydrate 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 monophosphate monohydrate 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 monophosphate monohydrate GMP manufacturer or sitagliptin monophosphate monohydrate GMP API supplier for your needs.
A sitagliptin monophosphate monohydrate CoA (Certificate of Analysis) is a formal document that attests to sitagliptin monophosphate monohydrate's compliance with sitagliptin monophosphate monohydrate specifications and serves as a tool for batch-level quality control.
sitagliptin monophosphate monohydrate CoA mostly includes findings from lab analyses of a specific batch. For each sitagliptin monophosphate monohydrate 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 monophosphate monohydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (sitagliptin monophosphate monohydrate EP), sitagliptin monophosphate monohydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (sitagliptin monophosphate monohydrate USP).
