DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 1Dr. Reddy's Laboratories
02 1Polpharma
03 2Biocon
04 1Hikal
05 1Zhejiang Jingsheng Pharmaceutical
01 2SITAGLIPTIN HYDROCHLORIDE
02 1SITAGLIPTIN HYDROCHLORIDE (ENZYMATIC)
03 1SITAGLIPTIN HYDROCHLORIDE (MONOHYDRATE)
04 1SITAGLIPTIN HYDROCHLORIDE (PROCESS B)
05 1SITAGLIPTIN HYDROCHLORIDE MONOHYDRATE
01 1China
02 4India
03 1Poland
01 6Active
01 3Complete
02 3Blank
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2020-12-18
Pay. Date : 2020-09-16
DMF Number : 34400
Submission : 2019-12-30
Status : Active
Type : II
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36129
Submission : 2021-07-19
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-04-11
Pay. Date : 2024-03-21
DMF Number : 37684
Submission : 2024-03-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-03-02
Pay. Date : 2022-01-20
DMF Number : 36558
Submission : 2022-02-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37288
Submission : 2022-06-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39440
Submission : 2024-01-27
Status : Active
Type : II
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