Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
01 1Malladi Drugs & Pharmaceuticals Limited
02 1LGM Pharma
03 1Fermion Oy
04 1HRV Global Life Sciences
05 1ALP Pharm
06 1Apotex Pharmachem
07 1Biotechnica DWC
08 1Cambrex Corporation
09 2Centaur Pharmaceuticals
10 1Cipla
11 1Dishman Carbogen Amcis
12 1Formil Quimica Ltd
13 1Fujifilm Diosynth Biotechnologies
14 1Globalchem
15 1Hexal AG
16 1IIQUIAP
17 1Lake Chemicals
18 1Osaka Synthetic Chemical Laboratories
19 1Par Pharmaceutical
20 1Pfizer Inc
21 1Qilu Tianhe Pharmaceutical Co., Ltd.
22 1R L Fine Chem
23 1Viatris
24 1Zambon Switzerland
25 1Blank
01 1Algeria
02 1Brazil
03 1Canada
04 2China
05 1Finland
06 1Germany
07 9India
08 1Japan
09 1Mexico
10 1Switzerland
11 5U.S.A
12 1United Kingdom
13 1Blank
01 7Active
02 7Inactive
03 12Blank
01 6Valid
02 1Withdrawn by Holder
03 19Blank
01 1217MF10394
02 1218MF10715
03 1219MF10128
04 23Blank
01 1WC-0093
02 1WC-0101
03 1WC-0107
04 1WC-0117
05 1WC-0128
06 1WC-0445A1
07 20Blank
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-07-17
Pay. Date : 2023-07-13
DMF Number : 20448
Submission : 2007-04-10
Status : Active
Type : II
Date of Issue : 2022-06-08
Valid Till : 2025-07-14
Written Confirmation Number : WC-0093
Address of the Firm :
NDC Package Code : 57218-312
Start Marketing Date : 2008-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2021-06-14
Registration Number : 20210614-209-J-1016
Manufacturer Name : Malladi Drugs & Pharmaceuticals Limited
Manufacturer Address : Unit-III, 7B&7C, Sipcot Industrial Complex, Ranipet-632 403, Ranipet District, India
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-12-30
Pay. Date : 2020-12-23
DMF Number : 9043
Submission : 1991-04-04
Status : Active
Type : II
Certificate Number : R1-CEP 2007-365 - Rev 01
Issue Date : 2020-01-13
Type : Chemical
Substance Number : 1065
Status : Valid
Registration Number : 219MF10128
Registrant's Address : Koivu-Mankkaan tie 6A, FI-02200 Espoo, Finland
Initial Date of Registration : 2007-04-18
Latest Date of Registration : --
NDC Package Code : 12780-4630
Start Marketing Date : 1991-04-04
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 : 18075
Submission : 2005-02-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18214
Submission : 2005-03-30
Status : Active
Type : II
Date of Issue : 2022-06-22
Valid Till : 2025-07-28
Written Confirmation Number : WC-0117
Address of the Firm :
NDC Package Code : 65015-634
Start Marketing Date : 2015-01-20
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 : 8060
Submission : 1989-05-06
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21828
Submission : 2008-07-10
Status : Inactive
Type : II
Certificate Number : R1-CEP 2008-229 - Rev 03
Issue Date : 2023-05-04
Type : Chemical
Substance Number : 1065
Status : Valid
Date of Issue : 2019-10-07
Valid Till : 2022-07-02
Written Confirmation Number : WC-0101
Address of the Firm :
Registrant Name : Unimed Pharmaceutical Co., Ltd.
Registration Date : 2021-12-03
Registration Number : 20210518-209-J-715(1)
Manufacturer Name : Lake Chemicals Pvt Ltd
Manufacturer Address : No. 21M, Attibele Industrial Area, Anekal Taluk Bangalore-562 107, India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8860
Submission : 1990-11-26
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 : 9128
Submission : 1991-05-20
Status : Inactive
Type : II
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