Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
01 1Nuray Chemicals Private Limited
02 1FARMAK, a.s
03 1Biophore India Pharmaceuticals Pvt Ltd
04 1Dr. Reddy's Laboratories
05 1Neuland Laboratories
06 1Aurobindo Pharma Limited
07 1Aurore Life Sciences
08 1Glenmark Life Sciences
09 1HONOUR LAB LTD
10 1MSN Laboratories
11 1Navinta
12 1Optimus Pharma
13 1Saptagir Laboratories
01 12TAFAMIDIS MEGLUMINE
02 1TAFAMIDIS MEGLUMINE (NON-MICRONIZED)
01 1Czech Republic
02 11India
03 1U.S.A
01 13Active
01 3Complete
02 10Blank
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 : 2020-09-15
Pay. Date : 2020-08-03
DMF Number : 35066
Submission : 2020-08-05
Status : Active
Type : II
Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38912
Submission : 2023-09-26
Status : Active
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37205
Submission : 2022-06-24
Status : Active
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37979
Submission : 2023-02-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36341
Submission : 2021-11-03
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-10-04
Pay. Date : 2022-09-07
DMF Number : 37492
Submission : 2022-09-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37152
Submission : 2022-06-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37026
Submission : 2022-03-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34696
Submission : 2020-03-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37177
Submission : 2022-08-16
Status : Active
Type : II
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