Chirogate is a professional Prostaglandin manufacturer.
01 1Chirogate International
02 1Nuray Chemicals Private Limited
03 1ChemWerth Inc
04 1Dr. Reddy's Laboratories
05 1HRV Global Life Sciences
06 1Apotex Pharmachem
07 1Everlight Chemical
08 2MSN Laboratories
09 1TIEN (Tianjin) Pharmaceutical
10 1Viatris
01 1Canada
02 1China
03 5India
04 2Taiwan
05 2U.S.A
01 6Active
02 5Blank
01 11Blank
01 11Blank
01 1WC-0416
02 10Blank
NDC Package Code : 68245-0010
Start Marketing Date : 2010-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
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 : 2017-03-17
Pay. Date : 2017-02-13
DMF Number : 31385
Submission : 2017-02-28
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 : 58159-036
Start Marketing Date : 2019-10-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (35kg/35kg)
Marketing Category : BULK INGREDIENT
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-01-08
Pay. Date : 2015-12-14
DMF Number : 30000
Submission : 2015-12-06
Status : Active
Type : II
NDC Package Code : 14501-0029
Start Marketing Date : 2015-02-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-03-09
Pay. Date : 2017-09-27
DMF Number : 32086
Submission : 2017-10-05
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-11-18
Pay. Date : 2016-06-16
DMF Number : 30535
Submission : 2016-04-28
Status : Active
Type : II
NDC Package Code : 65035-149
Start Marketing Date : 2016-08-16
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (10g/10g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31524
Submission : 2017-12-06
Status : Active
Type : II
NDC Package Code : 69870-108
Start Marketing Date : 2018-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (10g/10g)
Marketing Category : BULK INGREDIENT
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