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01 1ACETAZOLAMIDE
02 1APIXABAN
03 1APREMILAST
04 1ARIPIPRAZOLE
05 1ARIPIPRAZOLE MONOHYDRATE
06 1BACLOFEN
07 1BREXPIPRAZOLE
08 1CARBAMAZEPINE
09 1CARVEDILOL
10 1CARVEDILOL PHOSPHATE HEMIHYDRATE
11 1DAPAGLIFLOZIN
12 1DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE
13 1EMPAGLIFLOZIN
14 1ENZALUTAMIDE
15 1ETODOLAC
16 1HYDROCHLOROTHIAZIDE
17 1IBANDRONATE SODIUM MONOHYDRATE
18 1ISAVUCONAZONIUM SULFATE
19 1LAMOTRIGINE
20 1LINAGLIPTIN
21 1OXCARBAZEPINE
22 1PALBOCICLIB
23 1PENTOXIFYLLINE
24 1PIMAVANSERIN TARTRATE
25 1RIVAROXABAN
26 1SACUBITRIL/VALSARTAN COMPLEX
27 1SAFINAMIDE METHANESULFONATE
28 1SILDENAFIL CITRATE
29 1SITAGLIPTIN HYDROCHLORIDE MONOHYDRATE
30 1SODIUM ALENDRONATE
31 1SODIUM RISEDRONATE HEMI-PENTAHYDRATE
32 1SODIUM SALICYLATE
33 1TADALAFIL
34 1TICAGRELOR
35 1TOPIRAMATE
36 1TRAMETINIB DIMETHYL SULFOXIDE
37 1VARDENAFIL HYDROCHLORIDE TRIHYDRATE
38 1ZOLEDRONIC ACID MONOHYDRATE
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-30
Pay. Date : 2013-01-15
DMF Number : 10383
Submission : 1993-07-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-02-10
Pay. Date : 2016-12-20
DMF Number : 31166
Submission : 2016-11-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-04-07
Pay. Date : 2016-12-20
DMF Number : 31141
Submission : 2016-11-09
Status : Active
Type : II
KEY PRODUCTS
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
