Moehs Group, a reference company in the production of pharmaceutical active ingredients.
01 1Moehs Iberica
02 2Neuland Laboratories
03 1Arevipharma
04 1Aspire Lifesciences Pvt Ltd
05 1Cambrex Corporation
06 1Erregierre SpA
07 1Heumann
08 1Shaanxi Hanjiang pharmaceutical Group Co
09 1Siegfried AG
10 1Sifavitor srl
11 2Blank
01 1China
02 2Germany
03 3India
04 2Italy
05 1Spain
06 1Switzerland
07 1U.S.A
08 2Blank
01 4Active
02 6Inactive
03 3Blank
01 3Valid
02 2Withdrawn by Holder
03 8Blank
01 1302MF10102
02 12Blank
01 1WC-0036
02 1WC-0037
03 11Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-06-22
Pay. Date : 2021-06-16
DMF Number : 13992
Submission : 1999-02-22
Status : Active
Type : II
Certificate Number : CEP 2002-049 - Rev 08
Issue Date : 2024-03-12
Type : Chemical
Substance Number : 2004
Status : Valid
NDC Package Code : 52932-0715
Start Marketing Date : 2009-10-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : ASMF |
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-06-27
Pay. Date : 2014-06-23
DMF Number : 14951
Submission : 2000-07-13
Status : Active
Type : II
Certificate Number : CEP 2001-269 - Rev 09
Issue Date : 2024-03-06
Type : Chemical
Substance Number : 2004
Status : Valid
Date of Issue : 2022-07-28
Valid Till : 2025-06-16
Written Confirmation Number : WC-0036
Address of the Firm :
NDC Package Code : 58032-0803
Start Marketing Date : 2017-12-13
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2022-06-08
Valid Till : 2025-06-16
Written Confirmation Number : WC-0037
Address of the Firm :
NDC Package Code : 58032-0803
Start Marketing Date : 2017-12-13
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3721
Submission : 1980-02-13
Status : Active
Type : II
Certificate Number : R1-CEP 2003-196 - Rev 01
Issue Date : 2014-09-12
Type : Chemical
Substance Number : 2004
Status : Withdrawn by Holder
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12273
Submission : 1996-12-17
Status : Active
Type : II
Registration Number : 302MF10102
Registrant's Address : Via Curiel 34, 20067 Paulo, Milano, ITALY
Initial Date of Registration : 2020-08-18
Latest Date of Registration : --
NDC Package Code : 12828-0071
Start Marketing Date : 1996-12-05
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13186
Submission : 1998-09-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14841
Submission : 2000-04-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23752
Submission : 2010-04-19
Status : Inactive
Type : II
Certificate Number : CEP 2005-154 - Rev 04
Issue Date : 2024-02-20
Type : Chemical
Substance Number : 2004
Status : Valid
NDC Package Code : 10920-572
Start Marketing Date : 2010-11-23
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13083
Submission : 1998-07-21
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3754
Submission : 1980-03-12
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Sotalol Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sotalol Hydrochloride, including repackagers and relabelers. The FDA regulates Sotalol Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sotalol 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.
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A Sotalol Hydrochloride supplier is an individual or a company that provides Sotalol Hydrochloride active pharmaceutical ingredient (API) or Sotalol Hydrochloride finished formulations upon request. The Sotalol Hydrochloride suppliers may include Sotalol Hydrochloride API manufacturers, exporters, distributors and traders.
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