DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 1Dr. Reddy's Laboratories
02 1Zeon Pharma Industries India Pvt Ltd
03 2Chromo Laboratories
04 1Hetero Drugs
05 1Synergene Active Ingredients Pvt Ltd
06 1Unipex
07 1Zhejiang Ausun Pharmaceutical
01 1China
02 1France
03 6India
01 3Active
02 5Blank
01 8Blank
01 8Blank
01 1WC-0066
02 1WC-0067
03 1WC-0317
04 5Blank
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Date of Issue : 2022-06-17
Valid Till : 2025-07-07
Written Confirmation Number : WC-0067
Address of the Firm :
NDC Package Code : 55111-886
Start Marketing Date : 2008-02-06
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-12-20
Pay. Date : 2018-12-18
DMF Number : 26359
Submission : 2012-09-28
Status : Active
Type : II
Date of Issue : 2022-02-02
Valid Till : 2024-06-07
Written Confirmation Number : WC-0317
Address of the Firm :
NDC Package Code : 52562-800
Start Marketing Date : 2012-08-08
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 : 31869
Submission : 2017-08-18
Status : Active
Type : II
NDC Package Code : 52562-800
Start Marketing Date : 2012-08-08
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-03-13
Pay. Date : 2018-01-11
DMF Number : 32415
Submission : 2018-02-12
Status : Active
Type : II
Date of Issue : 2019-08-09
Valid Till : 2025-08-08
Written Confirmation Number : WC-0066
Address of the Firm :
NDC Package Code : 65977-0113
Start Marketing Date : 1999-09-17
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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