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API SUPPLIERS
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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
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
With Fermion, start the journey of your innovative API.
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
Lifecare Labs has been developing innovative products in specialist areas of medicine.
Dexmedetomidine Hydrochloride USP
Date of Issue : 2023-02-08
Valid Till : 2026-02-07
Written Confirmation Number : WC-0548
Address of the Firm : 102, Doyen Chambers, Behind Saradhi Studio, Yousufguda Road, Ameerpet Hyderabad ...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
With Fermion, start the journey of your innovative API.
Registrant Name : Korea Pfizer Pharmaceutical Co., Ltd.
Registration Date : 2010-05-27
Registration Number : Su5382-1-ND
Manufacturer Name : Fermion Oy
Manufacturer Address : Laaketehtaantie 2. FIN-90660 Oulu_x000D_
With Fermion, start the journey of your innovative API.
Registrant Name : Korea Pharmbio Co., Ltd.
Registration Date : 2024-05-01
Registration Number : Su5382-1-ND(2)
Manufacturer Name : Fermion Oy
Manufacturer Address : Laaketehtaantie 2. FIN-90660 Oulu
With Fermion, start the journey of your innovative API.
Registrant Name : Mpeak Korea Co., Ltd.
Registration Date : 2022-10-18
Registration Number : Su5382-1-ND(1)
Manufacturer Name : Fermion Oy
Manufacturer Address : Laaketehtaantie 2, FI-90660 Oulu, Finland
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
Registrant Name : Wooshin Labotech Co., Ltd.
Registration Date : 2025-09-29
Registration Number : Su579-6-ND
Manufacturer Name : MOEHS IBÉRICA, SL MGRC
Manufacturer Address : Poligono Industrial Rubí Sur C/ César Martinell i Brunet, 1008191 Rubí (Barcelona)...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]VMF
With Fermion, start the journey of your innovative API.
VMF Number : 5150
Submission : 1987-02-13
Status :
Type : II
With Fermion, start the journey of your innovative API.
VMF Number : 5721
Submission : 2001-05-21
Status :
Type : II
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Listed Suppliers
With Fermion, start the journey of your innovative API.
About the Company : Fermion, a wholly owned subsidiary of Orion Corporation and headquartered in Espoo, Finland, is a fully integrated CDMO offering API and formulation services. Its API portfolio inc...
Lifecare Labs has been developing innovative products in specialist areas of medicine.
About the Company : Lifecare Labs manufactures bulk drugs (APIs) and intermediates in line with stringent quality standards. The company focuses on delivering cost-effective solutions while meeting cu...
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
About the Company : ChemWerth, established in 1982, is a US-headquartered full-service generic API company. It supplies cGMP-quality APIs to regulated markets worldwide, with exclusive partnerships fo...
TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.
About the Company : Transo-Pharm is a licensed distributor of pharmaceutical components for human and veterinary markets. The company supports the full API life cycle, from development to sales, and a...
Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
About the Company : Transo-Pharm, founded in 1987, is a fully licensed global distributor of pharmaceutical components for health and veterinary industries. It supports customers throughout the API li...
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
About the Company : Since 1962, MOEHS has produced high-quality Active Pharmaceutical Ingredients (APIs) for the global market. With decades of technical expertise, Moehs Group delivers pharmaceutical...
China’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress
About the Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. specializes in API and advanced intermediate R&D and manufacturing, delivering comprehensive CDMO/CRO/OEM services and Finished ...
Deccan Nutraceuticals: A global leader in the integrated development, manufacturing, and marketing of pharmaceutical products.
About the Company : Deccan Nutraceuticals Pvt. Ltd. (DNPL) is a group company of Alkaloids Corporation (India), was founded in 2001 and operates from a 22,000 sq. m. facility in Pune (India). Their co...
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
About the Company : Supriya Lifescience Limited, established in 1987 and headquartered in Mumbai, is a globally recognized, technology-driven manufacturer of APIs, CDMO, and formulations. Its faciliti...
Maithri Drugs: Dedicated to your API needs.
About the Company : Maithri Drugs Pvt. Ltd. is a global supplier of Active Pharmaceutical Ingredients (APIs), serving pharmaceutical companies in 60+ countries. Its API portfolio spans antivirals, ant...
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
Drugs in Development
Lead Product(s) : Dexmedetomidine Hydrochloride,Inapplicable
Therapeutic Area : Undisclosed
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Safety, Tolerability and Efficacy of DEXDOR in Pediatric Patients in ICU
Details : Dexmedetomidine is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
January 23, 2019
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
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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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 DEXMEDETOMIDINE HCI manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DEXMEDETOMIDINE HCI, including repackagers and relabelers. The FDA regulates DEXMEDETOMIDINE HCI manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DEXMEDETOMIDINE HCI 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 HCI manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A DEXMEDETOMIDINE HCI supplier is an individual or a company that provides DEXMEDETOMIDINE HCI active pharmaceutical ingredient (API) or DEXMEDETOMIDINE HCI finished formulations upon request. The DEXMEDETOMIDINE HCI suppliers may include DEXMEDETOMIDINE HCI API manufacturers, exporters, distributors and traders.
click here to find a list of DEXMEDETOMIDINE HCI suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A DEXMEDETOMIDINE HCI DMF (Drug Master File) is a document detailing the whole manufacturing process of DEXMEDETOMIDINE HCI active pharmaceutical ingredient (API) in detail. Different forms of DEXMEDETOMIDINE HCI DMFs exist exist since differing nations have different regulations, such as DEXMEDETOMIDINE HCI USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A DEXMEDETOMIDINE HCI DMF submitted to regulatory agencies in the US is known as a USDMF. DEXMEDETOMIDINE HCI USDMF includes data on DEXMEDETOMIDINE HCI's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The DEXMEDETOMIDINE HCI USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of DEXMEDETOMIDINE HCI 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 HCI Drug Master File in Japan (DEXMEDETOMIDINE HCI JDMF) empowers DEXMEDETOMIDINE HCI 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 HCI JDMF during the approval evaluation for pharmaceutical products. At the time of DEXMEDETOMIDINE HCI 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 HCI 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 HCI Drug Master File in Korea (DEXMEDETOMIDINE HCI KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of DEXMEDETOMIDINE HCI. The MFDS reviews the DEXMEDETOMIDINE HCI KDMF as part of the drug registration process and uses the information provided in the DEXMEDETOMIDINE HCI KDMF to evaluate the safety and efficacy of the drug.
After submitting a DEXMEDETOMIDINE HCI 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 HCI API can apply through the Korea Drug Master File (KDMF).
click here to find a list of DEXMEDETOMIDINE HCI suppliers with KDMF on PharmaCompass.
A DEXMEDETOMIDINE HCI written confirmation (DEXMEDETOMIDINE HCI WC) is an official document issued by a regulatory agency to a DEXMEDETOMIDINE HCI manufacturer, verifying that the manufacturing facility of a DEXMEDETOMIDINE HCI active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting DEXMEDETOMIDINE HCI APIs or DEXMEDETOMIDINE HCI finished pharmaceutical products to another nation, regulatory agencies frequently require a DEXMEDETOMIDINE HCI WC (written confirmation) as part of the regulatory process.
click here to find a list of DEXMEDETOMIDINE HCI 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 HCI as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for DEXMEDETOMIDINE HCI 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 HCI 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 HCI and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a DEXMEDETOMIDINE HCI NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of DEXMEDETOMIDINE HCI suppliers with NDC on PharmaCompass.
DEXMEDETOMIDINE HCI 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 HCI 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 HCI GMP manufacturer or DEXMEDETOMIDINE HCI GMP API supplier for your needs.
A DEXMEDETOMIDINE HCI CoA (Certificate of Analysis) is a formal document that attests to DEXMEDETOMIDINE HCI's compliance with DEXMEDETOMIDINE HCI specifications and serves as a tool for batch-level quality control.
DEXMEDETOMIDINE HCI CoA mostly includes findings from lab analyses of a specific batch. For each DEXMEDETOMIDINE HCI 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 HCI may be tested according to a variety of international standards, such as European Pharmacopoeia (DEXMEDETOMIDINE HCI EP), DEXMEDETOMIDINE HCI JP (Japanese Pharmacopeia) and the US Pharmacopoeia (DEXMEDETOMIDINE HCI USP).
