Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
01 1Malladi Drugs & Pharmaceuticals Limited
02 1EUROAPI
03 1LGM Pharma
04 1Transo-Pharm Handels GmbH
05 1Jai Radhe Sales
06 1Moehs Iberica
07 1Beijing Mesochem Technology
08 1Amuna Pharmaceuticals
09 1Anvitha Lifecare
10 1Beijing Fukangren Biopharmaceutical
11 2Cambrex Corporation
12 1ChemPacific Corp
13 1Curia
14 1Hameln rds
15 1Hanways Chempharm
16 1Harman Finochem
17 1Hunan Warrant Chiral Pharmaceutical
18 1Mac-Chem Products (India) Pvt.Ltd
19 1Medinex Laboratories
20 1Recipharm AB
21 1Shenzhen Oriental Pharmaceutical
22 1Sun Pharmaceutical Industries Limited
23 1Surajlok Chemicals
24 1Wuhan Wuyao Pharmaceutical
25 1Blank
01 6China
02 1France
03 1Germany
04 8India
05 1Slovakia
06 1Spain
07 1Sweden
08 6U.S.A
09 1Blank
01 6Active
02 2Inactive
03 18Blank
01 7Valid
02 1Withdrawn by EDQM Failure to CEP procedure
03 18Blank
01 26Blank
01 1WC-0044
02 1WC-0168
03 1WC-0279
04 1WC-0435a
05 22Blank
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
Certificate Number : R1-CEP 2004-312 - Rev 01
Issue Date : 2021-12-10
Type : Chemical
Substance Number : 285
Status : Valid
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-11-19
Pay. Date : 2019-09-19
DMF Number : 33127
Submission : 2018-09-30
Status : Active
Type : II
Certificate Number : R0-CEP 2022-253 - Rev 00
Issue Date : 2023-08-08
Type : Chemical
Substance Number : 285
Status : Valid
Date of Issue : 2022-06-06
Valid Till : 2025-07-21
Written Confirmation Number : WC-0044
Address of the Firm :
NDC Package Code : 66064-1025
Start Marketing Date : 2017-02-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (5kg/5kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-01-03
Pay. Date : 2013-12-20
DMF Number : 16344
Submission : 2002-12-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35184
Submission : 2021-02-22
Status : Active
Type : II
Date of Issue : 2022-08-08
Valid Till : 2025-07-14
Written Confirmation Number : WC-0168
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-09-04
Pay. Date : 2019-07-11
DMF Number : 34008
Submission : 2019-07-31
Status : Active
Type : II
Certificate Number : R0-CEP 2020-089 - Rev 00
Issue Date : 2021-06-08
Type : Chemical
Substance Number : 285
Status : Valid
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-12-23
Pay. Date : 2015-07-23
DMF Number : 29562
Submission : 2015-07-31
Status : Active
Type : II
NDC Package Code : 65392-2301
Start Marketing Date : 1950-07-13
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (2.5kg/2.5kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-09-21
Pay. Date : 2013-09-11
DMF Number : 12037
Submission : 1996-07-10
Status : Active
Type : II
Certificate Number : CEP 2009-006 - Rev 03
Issue Date : 2023-11-08
Type : Chemical
Substance Number : 285
Status : Valid
NDC Package Code : 12828-0064
Start Marketing Date : 2000-09-07
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2021-01-08
Registration Number : 20210108-210-J-818
Manufacturer Name : Cambrex Profarmaco Milano Srl@Cambrex, Karlskoga AB
Manufacturer Address : 20067, Via Curiel, 34, Paullo (MI), ITALY@Björkborns Industriområde Karlskoga, 691 85, Sweden
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15367
Submission : 2001-03-30
Status : Inactive
Type : II
Certificate Number : R1-CEP 2014-316 - Rev 01
Issue Date : 2022-07-15
Type : Chemical
Substance Number : 285
Status : Valid
NDC Package Code : 65832-0001
Start Marketing Date : 2011-12-23
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Hyons Co., Ltd.
Registration Date : 2022-06-08
Registration Number : 20210420-210-J-944(2)
Manufacturer Name : Wuhan Wuyao Pharmaceutical Co., LTD.
Manufacturer Address : No.18, Wangfen Road, Fuchi Town, Yangxin County, Huangshi City, Hubei Province, China
Date of Issue : 2019-01-21
Valid Till : 2022-01-20
Written Confirmation Number : WC-0435a
Address of the Firm :
Certificate Number : CEP 2023-090 - Rev 01
Issue Date : 2024-08-01
Type : Chemical
Substance Number : 285
Status : Valid
Certificate Number : CEP 2024-212 - Rev 00
Issue Date : 2024-09-25
Type : Chemical
Substance Number : 285
Status : Valid
NDC Package Code : 12828-0064
Start Marketing Date : 2000-09-07
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2021-01-08
Registration Number : 20210108-210-J-818
Manufacturer Name : Cambrex Profarmaco Milano Srl@Cambrex, Karlskoga AB
Manufacturer Address : 20067, Via Curiel, 34, Paullo (MI), ITALY@Björkborns Industriområde Karlskoga, 691 85, Sweden
Certificate Number : R0-CEP 2014-363 - Rev 00
Issue Date : 2017-01-09
Type : Chemical
Substance Number : 285
Status : Withdrawn by EDQM F...
Date of Issue : 2021-10-05
Valid Till : 2024-06-24
Written Confirmation Number : WC-0279
Address of the Firm :
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 : 8020
Submission : 1989-04-10
Status : Inactive
Type : II
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