HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
01 1HRV Global Life Sciences
02 2Nuray Chemicals Private Limited
03 1Biophore India Pharmaceuticals Pvt Ltd
04 1Dasami Lab
05 1Emnar Pharma
06 1MSN Laboratories
01 1PITOLISANT
02 2PITOLISANT HYDROCHLORIDE
03 1PITOLISANT HYDROCHLORIDE IN-HOUSE
04 1PITOLISANT HYDROCHLORIDE SD
05 1PITOLISANT HYDROCHLORIDE SOLID DISPERSION
06 1Pitolisant Hydrochloride
01 7India
01 7Active
01 6Complete
02 1Blank
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39721
Submission : 2024-04-01
Status : Active
Type : II
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
GDUFA
DMF Review : Complete
Rev. Date : 2023-03-31
Pay. Date : 2023-03-15
DMF Number : 36859
Submission : 2022-03-01
Status : Active
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2023-07-28
Pay. Date : 2023-07-06
DMF Number : 37753
Submission : 2022-12-31
Status : Active
Type : II
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
GDUFA
DMF Review : Complete
Rev. Date : 2023-05-19
Pay. Date : 2023-03-21
DMF Number : 38174
Submission : 2023-03-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-06-22
Pay. Date : 2023-04-21
DMF Number : 38307
Submission : 2023-05-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-08-22
Pay. Date : 2024-07-25
DMF Number : 39126
Submission : 2023-12-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-05-17
Pay. Date : 2023-04-25
DMF Number : 38131
Submission : 2023-03-27
Status : Active
Type : II
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