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01 2Fermion Oy
02 1Lifecare Laboratories Pvt Ltd
03 1ChemWerth Inc
04 1Transo-Pharm USA LLC
05 1Transo-Pharm Handels GmbH
06 2Moehs Iberica
07 2Norchim
08 1Deccan Nutraceuticals Pvt. Ltd
09 1Supriya Lifescience
10 1Maithri Drugs
11 1Willow Birch Pharma
12 1Alcami
13 1Ascensus Specialties
14 1Asymchem Laboratories
15 1Beijing Fukangren Biopharmaceutical
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01 16160-10-ND
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06 1Su295-2-ND
07 1Su5382-1-ND
08 1Su55-5-ND
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GDUFA
DMF Review : Reviewed
Rev. Date : 2021-08-31
Pay. Date : 2021-08-26
DMF Number : 13810
Submission : 1998-10-30
Status : Active
Type : II
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 :
NDC Package Code : 12780-4640
Start Marketing Date : 1998-10-30
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Pfizer Korea
Registration Date : 2010-05-27
Registration Number : Su5382-1-ND
Manufacturer Name : Fermion Oy
Manufacturer Address : Laaketehtaantie 2. FIN-90660 Oulu_x000D_
VMF Number : 5721
Submission : 2001-05-21
Status : Active
Type : II
| Available Reg Filing : ASMF, BR, CN |
Date of Issue : 2026-05-13
Valid Till : 2029-05-12
Written Confirmation Number : WC-0548
Address of the Firm :
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-03-27
Pay. Date : 2012-12-17
DMF Number : 24202
Submission : 2011-12-15
Status : Active
Type : II
Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-03-21
Pay. Date : 2018-12-11
DMF Number : 33404
Submission : 2018-12-03
Status : Active
Type : II
NDC Package Code : 81912-0001
Start Marketing Date : 2021-07-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Wooshin Labotach 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), Spain
NDC Package Code : 56087-0001
Start Marketing Date : 2019-01-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
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.
NDC Package Code : 61281-9800
Start Marketing Date : 2023-12-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38761
Submission : 2023-08-30
Status : Active
Type : II
Date of Issue : 2024-02-12
Valid Till : 2027-02-11
Written Confirmation Number : WC-0407
Address of the Firm :
NDC Package Code : 70600-046
Start Marketing Date : 2023-08-14
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
| Available Reg Filing : BR |
85
PharmaCompass offers a list of Dexmedetomidine Hydrochloride 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 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.
A Dexmedetomidine HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dexmedetomidine HCl, including repackagers and relabelers. The FDA regulates Dexmedetomidine HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dexmedetomidine HCl 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 HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Dexmedetomidine HCl supplier is an individual or a company that provides Dexmedetomidine HCl active pharmaceutical ingredient (API) or Dexmedetomidine HCl finished formulations upon request. The Dexmedetomidine HCl suppliers may include Dexmedetomidine HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Dexmedetomidine HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
We have 43 companies offering Dexmedetomidine HCl
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