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API SUPPLIERS
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USDMF
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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
Maithri Drugs: Dedicated to your API needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38761
Submission : 2023-08-30
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]JDMF
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Dexmedetomidine hydrochloride (for manufacturing purposes only)
Registration Number : 218MF10833
Registrant's Address : Koivu-Mankkaan tie 6A, FI-02200 Espoo, Finland
Initial Date of Registration : 2006-10-20
Latest Date of Registration : 2021-07-01
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API Imports and Exports
Drugs in Development
Lead Product(s) : Dexmedetomidine Hydrochloride,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Dr. Reddy’s Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection is available in 200 mcg/50 mL (4 mcg/mL) and 400 mcg/100 mL (4 mcg/mL) in 50 mL and 100 mL clear glass vials, respectively.
Product Name : Dexmedetomidine Hydrochloride-Generic
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 25, 2020
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Regulatory Info :
Registration Country : Norway
Brand Name : Dexdor
Dosage Form : Concentrate to the infusion fluid, resolution
Dosage Strength : 100 mcg/ml
Packaging : Ampoule
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Dexdor
Dosage Form : Concentrate to the infusion fluid, resolution
Dosage Strength : 100 mcg/ml
Packaging : Hood glass
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Dexdor
Dosage Form : Concentrate to the infusion fluid, resolution
Dosage Strength : 100 mcg/ml
Packaging : Hood glass
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Dexdor
Dosage Form : Concentrate to the infusion fluid, resolution
Dosage Strength : 100 mcg/ml
Packaging : Ampoule
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Dexdor
Dosage Form : Concentrate For Solution For Infusion
Dosage Strength : 100mcg/ml
Packaging :
Approval Date : 16/09/2011
Application Number : 20101005000010
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Dexdor
Dosage Form : Concentrate For Infusion Solution
Dosage Strength : 100MCG
Packaging :
Approval Date : 2018-09-17
Application Number : 111718004
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Dexdor
Dosage Form : Concentrate For Infusion Solution
Dosage Strength : 100MCG
Packaging :
Approval Date : 2011-11-10
Application Number : 11718006
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Dexdor
Dosage Form : Concentrate For Infusion Solution
Dosage Strength : 100MCG
Packaging :
Approval Date : 2011-11-10
Application Number : 11718002
Regulatory Info : Authorized
Registration Country : Spain
Ever Pharma, highly specialized CDMO in producing complex injectables including high potency & controlled substances, suspensions, etc.
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Dexmedetomidine Ever Pharma
Dosage Form : Concentrate For Solution For Infusion
Dosage Strength : 100mcg/ml
Packaging :
Approval Date : 08/02/2018
Application Number : 20160402000092
Regulatory Info : Approved
Registration Country : Sweden
Ever Pharma, highly specialized CDMO in producing complex injectables including high potency & controlled substances, suspensions, etc.
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Dexmedetomidina Ever Pharma
Dosage Form : Concentrate For Infusion Solution
Dosage Strength : 100MCG
Packaging :
Approval Date : 2018-03-22
Application Number : 82586
Regulatory Info : Authorized
Registration Country : Spain
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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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PharmaCompass offers a list of Dexmedetomidine Hydrochloride 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 Dexmedetomidine Hydrochloride manufacturer or Dexmedetomidine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dexmedetomidine Hydrochloride manufacturer or Dexmedetomidine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Dexmedetomidine Hydrochloride API Price utilized in the formulation of products. Dexmedetomidine Hydrochloride API Price is not always fixed or binding as the Dexmedetomidine Hydrochloride Price is obtained through a variety of data sources. The Dexmedetomidine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Medetomidine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Medetomidine Hydrochloride, including repackagers and relabelers. The FDA regulates Medetomidine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Medetomidine Hydrochloride 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 Medetomidine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Medetomidine Hydrochloride supplier is an individual or a company that provides Medetomidine Hydrochloride active pharmaceutical ingredient (API) or Medetomidine Hydrochloride finished formulations upon request. The Medetomidine Hydrochloride suppliers may include Medetomidine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Medetomidine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Medetomidine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Medetomidine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Medetomidine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Medetomidine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Medetomidine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Medetomidine Hydrochloride USDMF includes data on Medetomidine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Medetomidine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Medetomidine Hydrochloride 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 Medetomidine Hydrochloride Drug Master File in Japan (Medetomidine Hydrochloride JDMF) empowers Medetomidine Hydrochloride 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 Medetomidine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Medetomidine Hydrochloride 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 Medetomidine Hydrochloride 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 Medetomidine Hydrochloride Drug Master File in Korea (Medetomidine Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Medetomidine Hydrochloride. The MFDS reviews the Medetomidine Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Medetomidine Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Medetomidine Hydrochloride 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 Medetomidine Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Medetomidine Hydrochloride suppliers with KDMF on PharmaCompass.
A Medetomidine Hydrochloride written confirmation (Medetomidine Hydrochloride WC) is an official document issued by a regulatory agency to a Medetomidine Hydrochloride manufacturer, verifying that the manufacturing facility of a Medetomidine Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Medetomidine Hydrochloride APIs or Medetomidine Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Medetomidine Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Medetomidine Hydrochloride 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 Medetomidine Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Medetomidine Hydrochloride 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 Medetomidine Hydrochloride 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 Medetomidine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Medetomidine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Medetomidine Hydrochloride suppliers with NDC on PharmaCompass.
Medetomidine Hydrochloride 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 Medetomidine Hydrochloride 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 Medetomidine Hydrochloride GMP manufacturer or Medetomidine Hydrochloride GMP API supplier for your needs.
A Medetomidine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Medetomidine Hydrochloride's compliance with Medetomidine Hydrochloride specifications and serves as a tool for batch-level quality control.
Medetomidine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Medetomidine Hydrochloride 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.
Medetomidine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Medetomidine Hydrochloride EP), Medetomidine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Medetomidine Hydrochloride USP).
