Synopsis
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CEP/COS
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JDMF
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VMF
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EDQM
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USP
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JP
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Others
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FDA Orange Book
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Australia
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Listed Dossiers
DRUG PRODUCT COMPOSITIONS
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FDF
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
Neuland Laboratories- A dedicated 100% API provider.
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
EU-WC
NDC
KDMF
ASMF, CN...
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Jai Radhe Sales is your partner for all your sourcing needs.
AMI Lifesciences is Driven by Chemistry. Powered by People.
Chynops Pharma is an ideal sourcing partner for high-quality APIs, advanced intermediates, speciality chemicals & excipients.
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USDMF
European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.
GDUFA
DMF Review : Complete
Rev. Date : 2019-07-16
Pay. Date : 2018-12-20
DMF Number : 33387
Submission : 2018-12-30
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33026
Submission : 2018-08-14
Status :
Type : II
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36048
Submission : 2021-06-28
Status :
Type : II
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39760
Submission : 2024-04-29
Status :
Type : II
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34235
Submission : 2019-10-15
Status :
Type : II
AMI Lifesciences is Driven by Chemistry. Powered by People.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38010
Submission : 2023-02-23
Status :
Type : II
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2018-11-21
Pay. Date : 2018-10-30
DMF Number : 32972
Submission : 2018-11-03
Status :
Type : II
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]Listed Suppliers
European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.
Dapagliflozin Propanediol Monohydrate
About the Company : Over 75 years of experience in process development and cGMP manufacturing make Polpharma API a key division of a leading Polish pharmaceutical group. Operating from our FDA-approve...
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Dapagliflozin Propanediol Monohydrate
About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Dapagliflozin Propanediol Monohydrate
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
About the Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. specializes in R&D and production of APIs and advanced intermediates, CDMO/CRO/OEM, and Technology Transfer of Finished Formulat...
Neuland Laboratories- A dedicated 100% API provider.
About the Company : Established in 1984, Neuland Laboratories Limited is a publicly listed company headquartered in Hyderabad, India. The company provides solutions across the entire spectrum of the p...
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Dapagliflozin Propanediol Monohydrate
About the Company : Cohance Lifesciences is a leading CDMO and API platform, offering products and services across all phases of a molecule’s lifecycle from development to commercialzation. With our...
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
About the Company : Egis is a member of the Servier Group. Egis’ products are manufactured at 3 production sites in Hungary, which are certified by EMA,FDA, ANVISA, PMDA ,KFDA. Egis sells its produc...
Jai Radhe Sales is your partner for all your sourcing needs.
Dapagliflozin Propanediol Monohydrate
About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...
AMI Lifesciences is Driven by Chemistry. Powered by People.
About the Company : Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory thera...
Chynops Pharma is an ideal sourcing partner for high-quality APIs, advanced intermediates, speciality chemicals & excipients.
Dapagliflozin Propanediol Monohydrate
About the Company : Chynops Pharma, a company certified with ISO 9001:2015, is situated in Ahmedabad, India. We specialize in exporting, supplying, and trading a wide range of products, including APIs...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
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API Imports and Exports
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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]Pluviaendo
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Silverline Chemicals
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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Granulation
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Disintegrants & Superdisintegrants
Coating Systems & Additives
Controlled & Modified Release
Chewable & Orodispersible Aids
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ANALYTICAL
ABOUT THIS PAGE
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PharmaCompass offers a list of Dapagliflozin Propanediol Monohydrate 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 Dapagliflozin Propanediol Monohydrate manufacturer or Dapagliflozin Propanediol Monohydrate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dapagliflozin Propanediol Monohydrate manufacturer or Dapagliflozin Propanediol Monohydrate supplier.
PharmaCompass also assists you with knowing the Dapagliflozin Propanediol Monohydrate API Price utilized in the formulation of products. Dapagliflozin Propanediol Monohydrate API Price is not always fixed or binding as the Dapagliflozin Propanediol Monohydrate Price is obtained through a variety of data sources. The Dapagliflozin Propanediol Monohydrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A BMS-512148-05 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of BMS-512148-05, including repackagers and relabelers. The FDA regulates BMS-512148-05 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. BMS-512148-05 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 BMS-512148-05 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A BMS-512148-05 supplier is an individual or a company that provides BMS-512148-05 active pharmaceutical ingredient (API) or BMS-512148-05 finished formulations upon request. The BMS-512148-05 suppliers may include BMS-512148-05 API manufacturers, exporters, distributors and traders.
click here to find a list of BMS-512148-05 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A BMS-512148-05 DMF (Drug Master File) is a document detailing the whole manufacturing process of BMS-512148-05 active pharmaceutical ingredient (API) in detail. Different forms of BMS-512148-05 DMFs exist exist since differing nations have different regulations, such as BMS-512148-05 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A BMS-512148-05 DMF submitted to regulatory agencies in the US is known as a USDMF. BMS-512148-05 USDMF includes data on BMS-512148-05's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The BMS-512148-05 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of BMS-512148-05 suppliers with USDMF 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 BMS-512148-05 Drug Master File in Korea (BMS-512148-05 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of BMS-512148-05. The MFDS reviews the BMS-512148-05 KDMF as part of the drug registration process and uses the information provided in the BMS-512148-05 KDMF to evaluate the safety and efficacy of the drug.
After submitting a BMS-512148-05 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 BMS-512148-05 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of BMS-512148-05 suppliers with KDMF on PharmaCompass.
A BMS-512148-05 written confirmation (BMS-512148-05 WC) is an official document issued by a regulatory agency to a BMS-512148-05 manufacturer, verifying that the manufacturing facility of a BMS-512148-05 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting BMS-512148-05 APIs or BMS-512148-05 finished pharmaceutical products to another nation, regulatory agencies frequently require a BMS-512148-05 WC (written confirmation) as part of the regulatory process.
click here to find a list of BMS-512148-05 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 BMS-512148-05 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for BMS-512148-05 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 BMS-512148-05 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 BMS-512148-05 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a BMS-512148-05 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of BMS-512148-05 suppliers with NDC on PharmaCompass.
BMS-512148-05 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 BMS-512148-05 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 BMS-512148-05 GMP manufacturer or BMS-512148-05 GMP API supplier for your needs.
A BMS-512148-05 CoA (Certificate of Analysis) is a formal document that attests to BMS-512148-05's compliance with BMS-512148-05 specifications and serves as a tool for batch-level quality control.
BMS-512148-05 CoA mostly includes findings from lab analyses of a specific batch. For each BMS-512148-05 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.
BMS-512148-05 may be tested according to a variety of international standards, such as European Pharmacopoeia (BMS-512148-05 EP), BMS-512148-05 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (BMS-512148-05 USP).
