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API Product List
 
Drug Master File (DMF)

























Active Pharmaceutical Ingredients


Sr. No. Current Product List Therapeutic uses USDMF CANADIAN DMF EDMF COS JAPANESE DMF
1 Amlodipine Besylate Anti Hypertensive *
2 Amlodipine Maleate Anti Hypertensive        
3 Bendroflumethiazide Anti Hypertensive, Diuretic    
4 Bisoprolol Hemifumarate B-Blocker    
5 Brimonidine Tartrate Anti Glucoma        
6 Buprenorphine Hydrochloride Post Operative Analgesic          
7 Clonidine Hydrochloride Anti Hypertensive      
8 Hydrochlorothiazide Anti Hypertensive,Diuretic    
9 Leflunomide Immunomodulator, Antirheumatic        
10 Meloxicam COX II Inhibitor     *
11 Metronidazole Anti Protozoal / Anti Amoebic    
12 Sertraline Hydrochloride Anti Depressant     *    
13 Telmisartan Anti Hypertensive          
14 Tizanidine Hydrochloride Muscle Relaxant      
* Under completion            
Note :Products protected by valid patents are not offered for sale in countries where the sale of such products constitutes a patent infringements.Also the onus of patent applicability shall remain with importer only.All above products would confirm to EP/BP/USP/JP(as applicable) or in-house specifications for non-pharmacopoeial products.



Active Pharmaceutical Ingredients
Ready for commercialisation
Sr. No. Product List Therapeutic uses USDMF CANADIAN DMF EDMF COS JAPANESE DMF
1 Aripiprazole Antipsychotic **   **    
2 Eprosartan Mesylate Anti Hypertensive **   **    
3 Escitalopram Anti Depressant **   **    
4 Lamotrigine Anti Epileptic **   **    
5 Levetiracetam Anticonvulsant **   **    
6 Losartan Potassium Anti Hypertensive **   **    
7 Pantoprazole Sodium Anti Ulcerative **   **    
8 Rosuvastatin HMG-CoA Reductase Inhibitor **   **    
9 Zafirlukast Anti Asthmatic **   **    
Under Development
1 Alfuzosin Alphablocker          
2 Amiodarone Anti Arrhythmic          
3 Erdosteine Mucolytic          
4 Eszopiclone Anti Insomnia          
5 Quetiapine Hydrochloride Anti Psychotic          
6 Ranolazine Anti Anginal          
7 Venlafaxine Anti Depressant          
** Proposed in the near future            
Note :Products protected by valid patents are not offered for sale in countries where the sale of such products constitutes patent infringement.Also the onus of patent applicability shall remain with importer only.All above products would confirm to EP/BP/USP/JP(as applicable) or in-house specifications for non-pharmacopoeial products.


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Drug Master Files (DMFs)

Product Country Document Status
Amlodipine Besylate EDQM COS Applied
Amlodipine Besylate USA DMF TYPE II Registered
Amlodipine Maleate EU EDMF Submitted
Bendroflumethiazide UK EDMF Submitted
Bendroflumethiazide USA DMF TYPE II Registered
Bendroflumethiazide EDQM COS Approved
Bisoprolol Fumarate EU EDMF Submitted
Bisoprolol Fumarate USA DMF TYPE II Registered
Clonidine HCl UK EDMF Submitted
Clonidine HCl USA DMF TYPE II Applied
Hydrochlorothiazide EDQM COS Approved
Hydrochlorothiazide EU EDMF Submitted
Hydrochlorothiazide USA DMF TYPE II Registered
Flutamide EDQM COS Approved
Flutamide EU EDMF Submitted
Leflunomide USA DMF TYPE II Registered
Meloxicam EU EDMF Submitted
Meloxicam USA DMF TYPE II Registered
Metronidazole EU EDMF Submitted
Metronidazole EDQM COS Approved
Metronidazole USA DMF TYPE II Registered
Phenyl Ephrine Hcl   COS Under compilation
Secnidazole   DMF Under compilation
Tizanidine Hcl USA DMF TYPE II Registered
Tizanidine Hcl EU EDMF Ready for submission
Vanlafaxine Hcl USA DMF Under compilation


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