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 1Evonik
04 1Nuray Chemicals Private Limited
05 1HRV Global Life Sciences
06 1TAPI Technology & API Services
07 1Biotechnica DWC
08 1Cambrex Corporation
09 1Centaur Pharmaceuticals
10 1Cipla
11 1F.I.S. Fabbrica Italiana Sintetici
12 1Formil Quimica Ltd
13 1Global Calcium
14 1IIQUIAP
15 1Kalintis Healthcare
16 1Lake Chemicals
17 1Nishchem International Pvt. Ltd
18 3R L Fine Chem
19 1RANBAXY LABORATORIES LIMITED
20 1Sandoz B2B
21 1Srini Pharmaceuticals
22 1Blank
01 1Algeria
02 1Brazil
03 1Germany
04 14India
05 1Israel
06 1Italy
07 1Mexico
08 1Switzerland
09 2U.S.A
10 1Blank
01 7Active
02 5Inactive
03 12Blank
01 6Valid
02 18Blank
01 1217MF10849
02 1218MF10781
03 22Blank
01 1WC-0093
02 1WC-0101
03 1WC-0107
04 1WC-0139
05 1WC-0445A2
06 1WC-0445A3
07 18Blank
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23247
Submission : 2009-11-05
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 : 57218-950
Start Marketing Date : 2009-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5041
Submission : 1983-07-09
Status : Active
Type : II
Certificate Number : R1-CEP 2008-142 - Rev 04
Issue Date : 2021-03-30
Type : Chemical
Substance Number : 1121
Status : Valid
NDC Package Code : 52696-0002
Start Marketing Date : 1983-07-09
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
NDC Package Code : 58159-103
Start Marketing Date : 2024-08-20
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (35kg/35kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19268
Submission : 2006-03-21
Status : Inactive
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-01-17
Pay. Date : 2023-01-13
DMF Number : 19006
Submission : 2005-11-28
Status : Active
Type : II
Certificate Number : CEP 2010-217 - Rev 03
Issue Date : 2024-01-25
Type : Chemical
Substance Number : 1121
Status : Valid
Date of Issue : 2020-03-31
Valid Till : 2022-07-28
Written Confirmation Number : WC-0445A3
Address of the Firm :
NDC Package Code : 71554-009
Start Marketing Date : 2019-04-27
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-01-29
Pay. Date : 2020-12-08
DMF Number : 35299
Submission : 2020-12-11
Status : Active
Type : II
NDC Package Code : 72166-001
Start Marketing Date : 2018-04-09
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 : 15156
Submission : 2000-11-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5747
Submission : 1985-03-13
Status : Inactive
Type : II
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