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
07 1Virchow Group
01 8India
01 7Active
02 1Blank
01 8Blank
01 8Blank
01 1WC-0416
02 7Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39721
Submission : 2024-04-01
Status : Active
Type : II
Available Reg Filing : AU |
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-03-31
Pay. Date : 2023-03-15
DMF Number : 36859
Submission : 2022-03-01
Status : Active
Type : II
Date of Issue : 2024-02-20
Valid Till : 2026-12-06
Written Confirmation Number : WC-0416
Address of the Firm :
NDC Package Code : 58159-084
Start Marketing Date : 2021-06-10
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (35kg/35kg)
Marketing Category : BULK INGREDIENT
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-07-28
Pay. Date : 2023-07-06
DMF Number : 37753
Submission : 2022-12-31
Status : Active
Type : II
NDC Package Code : 73435-034
Start Marketing Date : 2023-12-20
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-05-19
Pay. Date : 2023-03-21
DMF Number : 38174
Submission : 2023-03-30
Status : Active
Type : II
NDC Package Code : 58159-084
Start Marketing Date : 2021-06-10
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (35kg/35kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-06-22
Pay. Date : 2023-04-21
DMF Number : 38307
Submission : 2023-05-09
Status : Active
Type : II
NDC Package Code : 70966-0038
Start Marketing Date : 2019-08-14
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-08-22
Pay. Date : 2024-07-25
DMF Number : 39126
Submission : 2023-12-05
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-05-17
Pay. Date : 2023-04-25
DMF Number : 38131
Submission : 2023-03-27
Status : Active
Type : II
NDC Package Code : 14501-0114
Start Marketing Date : 2023-03-27
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
A Pitolisant manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pitolisant, including repackagers and relabelers. The FDA regulates Pitolisant manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pitolisant API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Pitolisant manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pitolisant supplier is an individual or a company that provides Pitolisant active pharmaceutical ingredient (API) or Pitolisant finished formulations upon request. The Pitolisant suppliers may include Pitolisant API manufacturers, exporters, distributors and traders.
click here to find a list of Pitolisant suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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