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 1Biotechnica DWC
07 1Cambrex Corporation
08 1Centaur Pharmaceuticals
09 1Cipla
10 1F.I.S. Fabbrica Italiana Sintetici
11 1Formil Quimica Ltd
12 1Global Calcium
13 1IIQUIAP
14 1Kalintis Healthcare
15 1Lake Chemicals
16 1Nishchem International Pvt. Ltd
17 3R L Fine Chem
18 1RANBAXY LABORATORIES LIMITED
19 1Sandoz B2B
20 1Srini Pharmaceuticals
21 1Teva API
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 : Reviewed
Rev. Date : 2014-06-27
Pay. Date : 2014-06-20
DMF Number : 5027
Submission : 1983-05-17
Status : Active
Type : II
Certificate Number : R1-CEP 2016-243 - Rev 00
Issue Date : 2022-12-16
Type : Chemical
Substance Number : 1121
Status : Valid
Registration Number : 217MF10849
Registrant's Address : Viale Milano 26 36075 Montecchio Maggiore Vicenza, Italy
Initial Date of Registration : 2005-11-01
Latest Date of Registration : --
NDC Package Code : 48087-0076
Start Marketing Date : 2010-04-09
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 : Reviewed
Rev. Date : 2020-09-25
Pay. Date : 2020-09-21
DMF Number : 4517
Submission : 1982-05-04
Status : Active
Type : II
Certificate Number : R1-CEP 2008-049 - Rev 02
Issue Date : 2022-04-19
Type : Chemical
Substance Number : 1121
Status : Valid
Registration Number : 218MF10781
Registrant's Address : Via Curiel 34, 20067 Paulo, Milano, ITALY
Initial Date of Registration : 2006-09-22
Latest Date of Registration : --
NDC Package Code : 12828-0025
Start Marketing Date : 1987-03-12
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-09-29
Pay. Date : 2013-09-23
DMF Number : 22460
Submission : 2009-01-23
Status : Active
Type : II
Certificate Number : CEP 2009-056 - Rev 03
Issue Date : 2023-10-19
Type : Chemical
Substance Number : 1121
Status : Valid
Date of Issue : 2022-06-08
Valid Till : 2025-06-25
Written Confirmation Number : WC-0107
Address of the Firm :
NDC Package Code : 64330-020
Start Marketing Date : 2003-01-23
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 : 4795
Submission : 1983-02-09
Status : Inactive
Type : II
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