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Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
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01 2Nuray Chemicals Private Limited
02 1Biophore India Pharmaceuticals Pvt Ltd
03 1Dasami Lab
04 1Emmennar Pharma
05 1MSN Laboratories
01 1PITOLISANT
02 2PITOLISANT HYDROCHLORIDE
03 1PITOLISANT HYDROCHLORIDE SD
04 1PITOLISANT HYDROCHLORIDE SOLID DISPERSION
05 1Pitolisant Hydrochloride
01 6India
01 6Active
01 6Complete
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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