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API Products

Product name Polymorph form CAS No. EU DMF US DMF No. CEP Other
Acenocumarol*
152-72-7 v


Acetazolamide [inj.] Form II 59-66-5 v 10383 v
Alendronate sodium Trihydrate 121268-17-5 v 16962 v Japanese DMF
Aniracetam Monoclinic form 72432-10-1 v


Aripiprazole [inj.] Type I 129722-12-9 v 23314 v
Avanafil Crystalline, none 330784-47-9 v Q4 2015

Baclofen [inj.] Form B 1134-47-0 v 18014 v Japanese DMF
Bazedoxifene acetate Form A 198481-33-3 Q2 2016 Q2 2016

Carbamazepine Form III 298-46-4 v 26266 v
Carvedilol Form II 72956-09-3 v 17060 v
Carvedilol phosphate hemihydrate Form I 610309-89-2 v 20633

Clopamide*
636-54-4 v


Cyclobenzaprine hydrochloride Crystalline, none 6202-23-9 v 18317

Etodolac Crystalline racemate, none 41340-25-4 v 11405 v Japanese DMF
Hydrochlorothiazide Form I 58-93-5 v 17599 v Japanese DMF
Ibandronate sodium [inj.] Monohydrate 138926-19-9 v 25638

Lamotrigine Anhydrous monoclinic 84057-84-1 v 20548 v Chinese DMF - under registration
Magnesium aspartate Amorphous 28184-71-6 v


Metronidazole [inj.] Monoclinic crystal system with space group P21/c 443-48-1 v 9294

Nefopam HCl*
23327-57-3 v


Opipramol dihydrochloride Amorphous 909-39-7 v


Pentoxifylline [inj.] Form I 1677687 v 20976 v
Phenyl salicylate Crystalline orthorhombic form 118-55-8 v


Piracetam [inj.] Form II 7491-74-9 v
v
Prasugrel hydrochloride Form B2 389574-19-0 Q1 2016 Q1 2016
Technical File
Prasugrel maleate Form 1
Q1 2016 Q1 2016
Technical File
Repaglinide Form I 135062-02-1 v 21149 v
Risedronate sodium Form A 329003-65-8 v 20384 v Japanese DMF
Salicylamide Monoclinic form (space group I2/a) 65-45-2 v


Sildenafil base

v 28319

Sildenafil citrate Anhydrous Form 171599-83-0 v 23930 v Japanese DMF / Chinese DMF
Sodium salicylate Monoclinic form (space group P21/m) 54-21-7 v 26873

Tolterodine tartrate Form 1 124937-52-6 v 24345

Topiramate Orthorhombic
structure
97240-79-4 v 20581

Zoledronic acid [inj.] Monohydrate 165800-06-6 v 24306
Japanese DMF
Xylometazoline HCl*
1218-35-5 v


AP ASMF (Applicant’s Part): 111 | RP ASMF (Restricted Part): 96 | US DMF: 28 / JAPANESE DMF: 7 | CEP: 17

*Polfa Warsaw API Manufacturing Site

DISCLAIMER
Products protected by valid patents are not offered for 'commercial' sale in countries where the sale of such products constitutes
patent infringement but are offered solely for uses reasonably related to the development and submission of information under a law
regulating the manufacture, use or sale of drugs. It is within the buyer’s responsibility and liability to check the patent situation of the
product in the imported market(s)