Neuland Laboratories- A dedicated 100% API provider.
01 1Neuland Laboratories
02 2Dr. Reddy's Laboratories
03 1Minakem (formerly Delmar Chemicals)
04 1Metrochem API Private Limited
05 1Cohance Lifesciences
06 1Hubei Gedian Humanwell Pharmaceutical
07 1Amoli Organics
08 1Aurobindo Pharma Limited
09 1Biocon
10 1CHEMO SMS ENTERPRISE SL
11 1Cipla
12 1Glenmark Life Sciences
13 1Hangzhou Huadong Medicine Group Kangrun Pharmaceutical
14 1Hetero Drugs
15 1Jiangxi Synergy Pharmaceutical
16 1Jubilant Generics
17 1Lupin Ltd
18 2MSN Laboratories
19 1Macleods Pharmaceuticals Limited
20 1Megafine Pharma (P) Limited
21 1Micro Labs Limited
22 2Optimus Pharma
23 1Piramal Pharma Solutions
24 1Solara Active Pharma Sciences
25 1Synthon Pharmaceuticals
26 1Unichem Laboratories Limited
27 1Vasudha Pharma Chem
28 1Viwit Pharmaceuticals Limited
29 1Zhejiang Huahai Pharmaceutical
30 1Zydus Lifesciences
01 1(1R)-2-[(2-(4-NITROPHENYL) ETHYL] AMINO] -1- PHENYL ETHANOL. HCL (MIRABEGRON INTERMEDIATE)
02 1(R) -ALPHA-[[[2-(4-NITRO-PHENYL)-ETHYL]AMINO]METHYL]BENZENE METHANOL(MIRABEGRON INTERMEDIATE)
03 24MIRABEGRON
04 1MIRABEGRON (FORM-B)
05 1MIRABEGRON (a-FORM)
06 1MIRABEGRON DRUG SUBSTANCE
07 1MIRABEGRON IH
08 1MIRABEGRON [FORM - AMORPHOUS]
09 1MIRABEGRON [PRODUCT CODE: AEB]
10 1MIRABEGRON [ROUTE CODE "MG"]
01 1Canada
02 5China
03 24India
04 1Netherlands
05 1U.S.A
06 1Blank
01 33Active
01 21Complete
02 12Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38770
Submission : 2023-08-31
Status : Active
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2014-09-29
Pay. Date : 2014-07-14
DMF Number : 28392
Submission : 2014-06-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-12-03
Pay. Date : 2018-07-09
DMF Number : 32929
Submission : 2018-09-14
Status : Active
Type : II
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36973
Submission : 2022-04-27
Status : Active
Type : II
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33821
Submission : 2019-04-26
Status : Active
Type : II
Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2023-10-03
Pay. Date : 2023-08-23
DMF Number : 38156
Submission : 2023-03-24
Status : Active
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2015-05-19
Pay. Date : 2015-03-04
DMF Number : 29064
Submission : 2015-02-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-04-27
Pay. Date : 2015-09-28
DMF Number : 29734
Submission : 2015-09-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-12-17
Pay. Date : 2015-09-29
DMF Number : 28071
Submission : 2014-03-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28420
Submission : 2014-06-25
Status : Active
Type : II
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