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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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NDC
KDMF
VMF
ASMF, BR
Lifecare Labs has been developing innovative products in specialist areas of medicine.
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.
Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
Suanfarma, at the Core of a Better Life.
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
NDC
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
Deccan Nutraceuticals: A global leader in the integrated development, manufacturing, and marketing of pharmaceutical products.
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
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USDMF
With Fermion, start the journey of your innovative API.
GDUFA
DMF Review : Complete
Rev. Date : 2021-08-31
Pay. Date : 2021-08-26
DMF Number : 13810
Submission : 1998-10-30
Status :
Type : II
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-27
Pay. Date : 2012-12-17
DMF Number : 24202
Submission : 2011-12-15
Status :
Type : II
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
GDUFA
DMF Review : Complete
Rev. Date : 2022-09-08
Pay. Date : 2022-01-27
DMF Number : 36478
Submission : 2022-01-10
Status :
Type : II
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
GDUFA
DMF Review : Complete
Rev. Date : 2019-03-21
Pay. Date : 2018-12-11
DMF Number : 33404
Submission : 2018-12-03
Status :
Type : II
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API Imports and Exports
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Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
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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 - SOLUTION;INTRAVENOUS - EQ 1MG BASE/1...DOSAGE - SOLUTION;INTRAVENOUS - EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)
USFDA APPLICATION NUMBER - 206628
DOSAGE - SOLUTION;INTRAVENOUS - EQ 200MCG BAS...DOSAGE - SOLUTION;INTRAVENOUS - EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)
USFDA APPLICATION NUMBER - 206628
DOSAGE - SOLUTION;INTRAVENOUS - EQ 400MCG BAS...DOSAGE - SOLUTION;INTRAVENOUS - EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)
USFDA APPLICATION NUMBER - 206628
DOSAGE - SOLUTION;INTRAVENOUS - EQ 400MCG BAS...DOSAGE - SOLUTION;INTRAVENOUS - EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)
USFDA APPLICATION NUMBER - 206628
DOSAGE - INJECTABLE;INJECTION - EQ 1MG BASE/2...DOSAGE - INJECTABLE;INJECTION - EQ 1MG BASE/250ML (EQ 4MCG BASE/ML)
USFDA APPLICATION NUMBER - 21038
DOSAGE - INJECTABLE;INJECTION - EQ 200MCG BAS...DOSAGE - INJECTABLE;INJECTION - EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)
USFDA APPLICATION NUMBER - 21038
DOSAGE - INJECTABLE;INJECTION - EQ 200MCG BAS...DOSAGE - INJECTABLE;INJECTION - EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)
USFDA APPLICATION NUMBER - 21038
DOSAGE - INJECTABLE;INJECTION - EQ 400MCG BAS...DOSAGE - INJECTABLE;INJECTION - EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)
USFDA APPLICATION NUMBER - 21038
DOSAGE - INJECTABLE;INJECTION - EQ 80MCG BASE...DOSAGE - INJECTABLE;INJECTION - EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)
USFDA APPLICATION NUMBER - 21038
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Dexmedetomidine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dexmedetomidine, including repackagers and relabelers. The FDA regulates Dexmedetomidine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dexmedetomidine 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 Dexmedetomidine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dexmedetomidine supplier is an individual or a company that provides Dexmedetomidine active pharmaceutical ingredient (API) or Dexmedetomidine finished formulations upon request. The Dexmedetomidine suppliers may include Dexmedetomidine API manufacturers, exporters, distributors and traders.
click here to find a list of Dexmedetomidine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dexmedetomidine DMF (Drug Master File) is a document detailing the whole manufacturing process of Dexmedetomidine active pharmaceutical ingredient (API) in detail. Different forms of Dexmedetomidine DMFs exist exist since differing nations have different regulations, such as Dexmedetomidine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dexmedetomidine DMF submitted to regulatory agencies in the US is known as a USDMF. Dexmedetomidine USDMF includes data on Dexmedetomidine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dexmedetomidine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dexmedetomidine 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 Dexmedetomidine Drug Master File in Japan (Dexmedetomidine JDMF) empowers Dexmedetomidine 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 Dexmedetomidine JDMF during the approval evaluation for pharmaceutical products. At the time of Dexmedetomidine 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 Dexmedetomidine 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 Dexmedetomidine Drug Master File in Korea (Dexmedetomidine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Dexmedetomidine. The MFDS reviews the Dexmedetomidine KDMF as part of the drug registration process and uses the information provided in the Dexmedetomidine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Dexmedetomidine 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 Dexmedetomidine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Dexmedetomidine suppliers with KDMF on PharmaCompass.
A Dexmedetomidine written confirmation (Dexmedetomidine WC) is an official document issued by a regulatory agency to a Dexmedetomidine manufacturer, verifying that the manufacturing facility of a Dexmedetomidine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Dexmedetomidine APIs or Dexmedetomidine finished pharmaceutical products to another nation, regulatory agencies frequently require a Dexmedetomidine WC (written confirmation) as part of the regulatory process.
click here to find a list of Dexmedetomidine 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 Dexmedetomidine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dexmedetomidine 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 Dexmedetomidine 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 Dexmedetomidine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dexmedetomidine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dexmedetomidine suppliers with NDC on PharmaCompass.
Dexmedetomidine 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 Dexmedetomidine 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 Dexmedetomidine GMP manufacturer or Dexmedetomidine GMP API supplier for your needs.
A Dexmedetomidine CoA (Certificate of Analysis) is a formal document that attests to Dexmedetomidine's compliance with Dexmedetomidine specifications and serves as a tool for batch-level quality control.
Dexmedetomidine CoA mostly includes findings from lab analyses of a specific batch. For each Dexmedetomidine 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.
Dexmedetomidine may be tested according to a variety of international standards, such as European Pharmacopoeia (Dexmedetomidine EP), Dexmedetomidine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dexmedetomidine USP).
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