Porton Pharma Solutions: Value creation via innovation & discovery through technical platforms.
01 1Porton Pharma Solutions
02 1Anwita Drugs & Chemicals Pvt Ltd
03 1Emcure Pharmaceuticals
04 1Olon S.p.A
05 1Shanghai Desano Bio-Pharmaceutical
06 1Siegfried AG
07 1Sifavitor srl
08 1Blank
01 2China
02 2India
03 2Italy
04 1Switzerland
05 1Blank
01 3Active
02 3Inactive
03 2Blank
01 1Valid
02 7Blank
01 8Blank
01 1WC-0226
02 7Blank
Porton Pharma Solutions: Value creation via innovation & discovery through technical platforms.
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15413
Submission : 2001-05-04
Status : Active
Type : II
NDC Package Code : 75877-0005
Start Marketing Date : 2017-11-28
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 : 15687
Submission : 2001-10-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16127
Submission : 2002-09-06
Status : Active
Type : II
NDC Package Code : 17381-840
Start Marketing Date : 2010-04-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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 : 7549
Submission : 1988-06-21
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22138
Submission : 2008-10-23
Status : Inactive
Type : II
Date of Issue : 2019-10-07
Valid Till : 2022-07-02
Written Confirmation Number : WC-0226
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26883
Submission : 2013-02-06
Status : Inactive
Type : II
Certificate Number : CEP 2011-099 - Rev 04
Issue Date : 2024-07-11
Type : Chemical
Substance Number : 1241
Status : Valid
NDC Package Code : 17337-0528
Start Marketing Date : 2017-03-03
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : DKS Korea Co., Ltd.
Registration Date : 2022-09-28
Registration Number : 20220928-209-J-1371
Manufacturer Name : Olon SPA
Manufacturer Address : VIA LIVELLI, 1(loc. FRAZIONE MAIRANO) - 26852 CASALETTO LODIGIANO (LO), Italy
A (+/-)-Mefloquine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of (+/-)-Mefloquine Hydrochloride, including repackagers and relabelers. The FDA regulates (+/-)-Mefloquine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. (+/-)-Mefloquine 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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