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01 1Jai Radhe Sales
02 1HRV Global Life Sciences
03 1Zeon Pharma Industries India Pvt Ltd
04 1Bazayan & Co
05 1Cadila Pharmaceuticals
06 1Divis Laboratories
07 1EASTMAN KODAK
08 1ERREDUE S.P.A. IT 24040 Isso
09 1HELM Portugal
10 2Harman Finochem
11 1JPN Pharma
12 1KUNSHAN ORIENTAL PHARMACEUTICAL CO LTD
13 1Katwijk Chemie
14 1Kreative Organics
15 1Orchid Pharma
16 1Pfizer Inc
17 2Recordati
18 1Sinbiotik
19 1Swati Spentose
20 1Unichem Laboratories Limited
21 1Zim Laboratories
01 1China
02 14India
03 3Italy
04 1Mexico
05 1Netherlands
06 1Portugal
07 2U.S.A
01 8Active
02 4Inactive
03 11Blank
01 2Valid
02 21Blank
01 23Blank
01 1WC-0044
02 1WC-0045nA2
03 1WC-0062
04 1WC-0165
05 19Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-10-14
Pay. Date : 2015-09-30
DMF Number : 17862
Submission : 2004-12-02
Status : Active
Type : II
Certificate Number : R1-CEP 2016-038 - Rev 00
Issue Date : 2023-01-11
Type : Chemical
Substance Number : 521
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 : 66064-6001
Start Marketing Date : 2004-11-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20453
Submission : 2007-04-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20433
Submission : 2007-03-25
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-05-31
Pay. Date : 2018-03-27
DMF Number : 32676
Submission : 2018-03-29
Status : Active
Type : II
Date of Issue : 2022-06-17
Valid Till : 2025-07-21
Written Confirmation Number : WC-0062
Address of the Firm :
NDC Package Code : 53747-082
Start Marketing Date : 2018-03-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-09-28
Pay. Date : 2015-09-15
DMF Number : 5384
Submission : 1984-06-06
Status : Active
Type : II
Certificate Number : R1-CEP 2015-151 - Rev 00
Issue Date : 2020-10-14
Type : Chemical
Substance Number : 521
Status : Valid
NDC Package Code : 17349-0004
Start Marketing Date : 1984-06-06
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4531
Submission : 1982-04-07
Status : Active
Type : II
NDC Package Code : 12711-4466
Start Marketing Date : 1969-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-10-18
Pay. Date : 2024-10-15
DMF Number : 4538
Submission : 1982-04-07
Status : Active
Type : II
NDC Package Code : 12711-4466
Start Marketing Date : 1969-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16301
Submission : 2002-12-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7348
Submission : 1988-02-25
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7304
Submission : 1988-01-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15848
Submission : 2002-01-31
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7229
Submission : 1987-11-20
Status : Inactive
Type : II
NDC Package Code : 0009-0087
Start Marketing Date : 2013-12-13
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2019-07-08
Valid Till : 2022-07-08
Written Confirmation Number : WC-0165
Address of the Firm :
NDC Package Code : 52119-006
Start Marketing Date : 2012-08-20
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2022-06-08
Valid Till : 2025-07-21
Written Confirmation Number : WC-0045nA2
Address of the Firm :
NDC Package Code : 66064-6001
Start Marketing Date : 2004-11-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
A Dilantin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dilantin, including repackagers and relabelers. The FDA regulates Dilantin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dilantin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Dilantin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dilantin supplier is an individual or a company that provides Dilantin active pharmaceutical ingredient (API) or Dilantin finished formulations upon request. The Dilantin suppliers may include Dilantin API manufacturers, exporters, distributors and traders.
click here to find a list of Dilantin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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