01 1Alembic Pharmaceuticals Limited
02 1Esteve Quimica
03 1Hetero Drugs
04 1MSN Laboratories
05 1Pfizer Inc
01 3India
02 1Spain
03 1U.S.A
01 2Active
02 3Blank
01 5Blank
01 1307MF10038
02 4Blank
01 1WC-0349
02 4Blank
01 1Su173-57-ND
02 1Su87-32-ND
03 1Su87-40-ND
04 2Blank
01 154893-0048
02 4Blank
01 5Blank
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GDUFA
DMF Review : Reviewed
Rev. Date : 2025-07-28
Pay. Date : 2025-07-08
DMF Number : 30683
Submission : 2016-07-08
Status : Active
Type : II
Registration Number : 307MF10038
Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, India.
Initial Date of Registration : 2025-02-26
Latest Date of Registration :
Date of Issue : 2022-09-02
Valid Till : 2025-05-05
Written Confirmation Number : WC-0349
Address of the Firm :
NDC Package Code : 54893-0048
Start Marketing Date : 2016-06-27
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2025-05-07
Registration Number : Su173-57-ND
Manufacturer Name : MSN Laboratories Private Limited
Manufacturer Address : (Unit-ll) Sy. No. 50, 53, 53/A, 54 & 54/A, Kardanur (Village), Patancheru (Mandal), Sangareddy District, Telangana, Pincode: 502 300, India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39380
Submission : 2024-05-09
Status : Active
Type : II
Registrant Name : Korea Pfizer Pharmaceutical Co., Ltd.
Registration Date : 2025-02-28
Registration Number : Su87-40-ND
Manufacturer Name : Esteve Quimica SA
Manufacturer Address : c/Ter, 94, Poligon Industrial, 17460 Celra (Girona), Spain
Registrant Name : Korea Pfizer Pharmaceutical Co., Ltd.
Registration Date : 2023-01-13
Registration Number : Su87-32-ND
Manufacturer Name : Pfizer Ireland Pharmaceuticals
Manufacturer Address : Ringaskiddy API Plant, PO Box 140, Ringaskiddy, Co. Cork, Ireland
36
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