DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 1Dr. Reddy's Laboratories
02 1Polpharma
03 1Ami Lifesciences Private Limited
04 1Alembic Pharmaceuticals Limited
05 1Amoli Organics
06 1Aurobindo Pharma Limited
07 1HONOUR LAB LTD
08 1Harman Finochem
09 2Jiangsu Lianhuan Pharmaceutical
10 1Laurus Labs
11 1Lupin Ltd
12 3MSN Laboratories
13 1Macleods Pharmaceuticals Limited
14 1Mankind Pharma
15 1TAPI Technology & API Services
16 1Viatris
17 1Wisdom Pharmaceutical
18 1Zhejiang Tianyu Pharmaceutical Co., Ltd
19 1Zhuhai Rundu Pharmaceutical
01 1SACUBITRIL AND VALSARTAN
02 1SACUBITRIL AND VALSARTAN (AMORPHOUS)
03 1SACUBITRIL AND VALSARTAN (FORM-S)
04 1SACUBITRIL VALSARTAN 3NA COMPLEX
05 3SACUBITRIL VALSARTAN SODIUM
06 1SACUBITRIL VALSARTAN SODIUM (INTERNAL CODE: LCZ696)
07 1SACUBITRIL VALSARTAN SODIUM ON COLLOIDAL SILICON DIOXIDE
08 1SACUBITRIL VALSARTAN TRISODIUM (AMORPHOUS)
09 1SACUBITRIL VALSARTAN TRISODIUM HEMIPENTAHYDRATE
10 1SACUBITRIL VALSARTAN TRISODIUM SALT HEMIPENTAHYDRATE
11 1SACUBITRIL-VALSARTAN PREMIX
12 7SACUBITRIL/VALSARTAN
13 2SACUBITRIL/VALSARTAN COMPLEX
01 5China
02 14India
03 1Israel
04 1Poland
05 1U.S.A
01 21Active
02 1Inactive
01 14Complete
02 8Blank
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2017-12-22
Pay. Date : 2017-11-08
DMF Number : 31574
Submission : 2017-08-29
Status : Active
Type : II
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : Complete
Rev. Date : 2018-09-04
Pay. Date : 2017-12-20
DMF Number : 32337
Submission : 2017-12-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37994
Submission : 2023-03-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-03-27
Pay. Date : 2019-02-05
DMF Number : 33452
Submission : 2019-02-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-03-08
Pay. Date : 2019-02-01
DMF Number : 33455
Submission : 2019-01-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32171
Submission : 2017-12-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-04-30
Pay. Date : 2019-04-15
DMF Number : 33398
Submission : 2018-12-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-02-19
Pay. Date : 2018-10-31
DMF Number : 32325
Submission : 2017-12-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-04-12
Pay. Date : 2018-12-20
DMF Number : 33457
Submission : 2019-02-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32254
Submission : 2017-12-07
Status : Active
Type : II
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