Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
01 2Metrochem API Private Limited
02 1Cohance Lifesciences
03 1Dr. Reddy's Laboratories
04 1Neuland Laboratories
05 1ALP Pharm
06 1Apotex Pharmachem
07 2Biocon
08 4BrightGene Bio-Medical Technology Co.,Ltd
09 1HONOUR LAB LTD
10 1Jiangsu Hansyn Pharmaceutical Co Ltd
11 3MSN Laboratories
12 1Olon S.p.A
13 1Quimica Sintetica
14 1Shandong Jincheng Pharm.&Chem. Co., Ltd.
15 1Solara Active Pharma Sciences
16 3WUHAN ZY PHARMACEUTICAL CO LTD
17 1Zhejiang Ausun Pharmaceutical
01 1POSA-12 (POSACONAZOLE INTERMEDIATE)
02 12POSACONAZOLE
03 1POSACONAZOLE FOMR I
04 1POSACONAZOLE (FORM I)
05 1POSACONAZOLE (FORM-I)
06 1POSACONAZOLE (FORM-I) [ROUTE CODE - "PJ1"]
07 1POSACONAZOLE (NON STERILE API)
08 1POSACONAZOLE AMORPHOUS (PROCESS-2) [ROUTE CODE - "PKA"]
09 1POSACONAZOLE AMORPHOUS [ROUTE CODE PKA]
10 1POSACONAZOLE CRYSTALLINE I (NON-STERILE, API)
11 1POSACONAZOLE CRYSTALLINE III
12 1POSACONAZOLE FORM 1
13 2POSACONAZOLE FORM I
14 1POSACONAZOLE FORM-1
01 1Canada
02 11China
03 12India
04 1Italy
05 1Spain
01 26Active
01 19Complete
02 7Blank
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 : 35517
Submission : 2021-01-11
Status : Active
Type : II
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2020-08-06
Pay. Date : 2020-03-05
DMF Number : 34451
Submission : 2019-12-24
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 : 2018-03-20
Pay. Date : 2018-02-26
DMF Number : 32098
Submission : 2017-09-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-12-27
Pay. Date : 2019-12-05
DMF Number : 28826
Submission : 2018-05-03
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 : Complete
Rev. Date : 2024-08-23
Pay. Date : 2024-08-02
DMF Number : 36969
Submission : 2022-06-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28223
Submission : 2017-01-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-26
Pay. Date : 2014-06-06
DMF Number : 28314
Submission : 2014-06-10
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-03-03
Pay. Date : 2015-09-23
DMF Number : 27720
Submission : 2013-11-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-04-28
Pay. Date : 2014-10-08
DMF Number : 27614
Submission : 2013-10-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24346
Submission : 2010-11-05
Status : Active
Type : II
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