GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28449
Submission : 2014-06-16
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36506
Submission : 2022-06-16
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 42963
Submission : 2025-11-20
Status : Active
Type : II
Certificate Number : R1-CEP 2016-283 - Rev 01
Issue Date : 2023-01-12
Type : Chemical
Substance Number : 1444
Status : Valid
NDC Package Code : 57449-010
Start Marketing Date : 2025-08-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2025-12-17
Registration Number : 20251217-211-J-2091
Manufacturer Name : AVESTA PHARMA PVT. LTD
Manufacturer Address : Plot No. 2, Gut No 189/1, 189/2, 191/2, 191/6, 194, 165/3, 166, 167, 168, 169 AT Post-Alonde, Tal-Vikramgad, Palghar 421303 Maharashtra State, India

Certificate Number : CEP 2006-085 - Rev 05
Issue Date : 2025-04-25
Type : Chemical
Substance Number : 1444
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
NDC Package Code : 59044-0017
Start Marketing Date : 2018-06-21
End Marketing Date : 2027-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2024-418 - Rev 00
Issue Date : 2025-03-26
Type : Chemical
Substance Number : 1444
Status : Valid

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Certificate Number : CEP 2009-392 - Rev 02
Issue Date : 2026-01-21
Type : Chemical
Substance Number : 1444
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
NDC Package Code : 59044-0007
Start Marketing Date : 2006-03-01
End Marketing Date : 2027-12-31
Dosage Form (Strength) : POWDER (22.7kg/22.7kg)
Marketing Category : BULK INGREDIENT

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
NDC Package Code : 59044-0027
Start Marketing Date : 2006-03-01
End Marketing Date : 2027-12-31
Dosage Form (Strength) : POWDER (907kg/907kg)
Marketing Category : BULK INGREDIENT

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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