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02 1Dr. Reddy\'s Laboratories
03 1Apothecon Pharmaceuticals
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07 1Harman Finochem
08 1Hikma Pharmaceuticals
09 1Hunan Huateng Pharmaceutical Co ltd
10 1Kalintis Healthcare
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GDUFA
DMF Review : Reviewed
Rev. Date : 2012-10-25
Pay. Date : 2012-12-19
DMF Number : 6914
Submission : 1987-04-09
Status : Active
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-04-02
Pay. Date : 2021-03-30
DMF Number : 7033
Submission : 1987-06-18
Status : Active
Type : II
NDC Package Code : 30007-817
Start Marketing Date : 2010-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-11-06
Pay. Date : 2018-09-28
DMF Number : 33126
Submission : 2018-09-30
Status : Active
Type : II
NDC Package Code : 66064-1023
Start Marketing Date : 2017-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-02-24
Pay. Date : 2013-10-22
DMF Number : 23719
Submission : 2010-06-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33480
Submission : 2019-01-10
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-12-29
Pay. Date : 2018-10-11
DMF Number : 32136
Submission : 2018-02-09
Status : Active
Type : II
NDC Package Code : 76339-138
Start Marketing Date : 2019-09-06
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (4.999kg/4.999kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28840
Submission : 2015-12-03
Status : Active
Type : II
NDC Package Code : 64181-0088
Start Marketing Date : 1996-12-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (100g/100g)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-08-21
Pay. Date : 2020-07-29
DMF Number : 34964
Submission : 2020-07-29
Status : Active
Type : II
NDC Package Code : 72166-005
Start Marketing Date : 2018-04-09
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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