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EU CTD Dossiers

EU Dossiers with BE studies whereever applicable can be made available , subject to conditions of supply. Products are manufactured in accordance with EU directives for GMP Complaince. Finished Product Manufactuirng is done either in India or in Europe.

Product Strength Presentation Dossier Format Status
5-Fluorouracil 250, 500, 1000, 5000mg Solution for injection EU CTD Ready
Acarbose 50mg / 100mg tablets EU CTD Ready
Aceclofencac 100mg tablets EU CTD Ready
Acetylcysteine 200mg, 600mg Effervescent tabs EU CTD Ready
Aciclovir 800 mg tabl. EU CTD Ready
Aciclovir 5% cream, gel EU CTD Ready
Aciclovir 250 mg inj. EU CTD Ready
Alendronate 70mg tablets EU CTD Ready
Allopurinol 100 mg, 300mg tabl. EU CTD Ready
Amlodipine 5-10 mg Capsules, tablets EU CTD ready
Amlodipine besylate 5 mg,10mg tabl. EU CTD Ready
Amlodipine maleate 5 mg, 10mg tabl. EU CTD Ready
Amorolfine 125mg Bottles EU CTD Ready
Amoxicillin  250,500 mg Capsules EU CTD Ready
Amoxicillin-Clavulanic Acid (ratio 8:1) 500mg-62.5mg tablets EU CTD Ready
Anastrazole 1mg Tablets EU CTD Ready
Aripiprazole  5,10,15,30 mg Tablets EU CTD  Jul-08
Atenolol 25mg, 50mg, 100mg Tablets EU CTD Ready
Atorvastatin 10mg,20mg,40mg,80mg tablets EU CTD Ready
Azithromycin 250mg, 500mg Dispersible tabs / CelDis EU CTD Ready
Azithromycin 500mg injectables EU CTD Ready
Azithromycin Dihydrate 250mg, 500mg Tablets EU CTD Ready
Azithromycin Dihydrate 200mg / 100ml Suspension EU CTD Ready
Becaplermin  15g  tubes with 0.01% gel EU CTD Ready
Betaxolol 0.5% w/v 5ml PL 15872 / 0007 eye drops EU CTD Ready
Biclutamide 50 mg, 100mg, 150mg tabl. EU CTD Ready
Bisoprolol 1.25 mg, 2.5mg, 3.75mg,5mg, 10mg tabl. EU CTD Ready
Bromazepam 3,6 mg  sustained release tablets EU CTD Ready
Calciumfolinate 50, 100, 200, 400, 500, 800, 1000mg Solution for injection EU CTD Ready
Captopril 25mg / 50mg tablets EU CTD Ready
Carboplatin 50mg, 150 mg , 450mg lyophilized EU CTD Ready
Carvedilol 6.25mg / 25mg tablets EU CTD Ready
Cefaclor 250 mg, 500mg caps. EU CTD Ready
Cefazolin  1 g Powder for Inj EU CTD Ready
Cefotaxime 250, 500mg , 1g , 2 g Powder for Inj EU CTD Ready
Cefpodoxime Proxetil 100mg tablets EU CTD Ready
Ceftazidime  250, 500mg , 1g , 2 g Powder for Inj EU CTD Ready
Ceftriaxone sodium 500 mg, 1 gm Powder for Inj EU CTD Ready
Cefuroxime Axetil  125mg, 250mg, 500mg tablets EU CTD Ready
Cefuroxime sodium  750 mg, 1.5 g Powder for Inj EU CTD Ready
Cephalexin  250*, 500 mg Capsules EU CTD Ready
Ceterizine & Pseudoefedrin 5mg & 120mg Capsules EU CTD Ready
Cetirizine 10 mg tabl. EU CTD Ready
Cetrizine 10 mg Tablets EU CTD Ready
Chlormadinone-Ethinylestradiol 2mg - 0.030mg tablets EU CTD Ready
Cilazapril 0.5, 1, 2.5, 5mg tablets EU CTD under development
Cimetidine 200mg, 400mg, 800mg Film coated tablets EU CTD Ready
Cinnarizine 75mg, 150mg sustained release tablets EU CTD Ready
Ciprofloxacin 250mg / 500mg tablets EU CTD Ready
Ciprofloxacin 2mg/ml [bottles with 100ml and 200ml injectables EU CTD Ready
Citalopram 10, 20, 30, 40mg tablets EU CTD Ready
Clarithromycin 250, 500mg tablets EU CTD Ready
Clarithromycin 500 mg inj. EU CTD Ready
Clindamycin 75 mg, 150mg,300mg caps. EU CTD Ready
Clopidogrel 75mg tablets EU CTD Q3 / 08
Co-Amoxiclav 600 mg, 1.2 g Powder for Inj EU CTD Ready
Cyproterone - Ethinylestradiol 2mg - 0.030mg tablets EU CTD Ready
Dacarbazine 100mg, 200mg lyophilized EU CTD Ready
Desogestrel 0.075mg tablets EU CTD Ready
Docetaxel 20mg - 80mg Bottles EU CTD Ready
Docetaxel 20mg, 80mg lyophilized EU CTD Ready
Domperidone 10 mg tabl.  EU CTD Ready
Donepezil 5mg and 10mg film.coat.tabl. EU CTD Ready
Doxorubicin 10mg, 50mg, 150mg Powder for injection EU CTD Ready
Doxycycline 50 mg, 100mg caps. EU CTD Ready
Ebastine 10,20mg tablets EU CTD Ready
Enalapril 5,20mg tablets EU CTD Ready
Enoxaparin 20mg, 40mg, 60mg, 80mg prefilled syringe EU CTD Ready
Epirubicin 10, 20, 50, 100, 200mg Solution for injection EU CTD Ready
Escitalopram 10, 20mg tablets EU CTD Ready
Etoposide 100mg, 500mg, 1000mg Concentrate for infusion EU CTD Ready
Felodipine 2.5 mg, 5mg, 10mg tabl. EU CTD Ready
Fexofenadine 120 mg, 180mg tabl. EU CTD Ready
Filgrastim 300mcg  solution in prefilled syringe EU CTD Ready
Finasteride 5mg Film coated tablets EU CTD Ready
Fluconazole 50mg,150mg,200mg PL 15872/0011-0001 Capsules EU CTD Ready
Fluconazole 50, 100, 150, 200mg Capsules EU CTD Ready
Fluconazole 2mg / ml, 200mg / 5ml Solution for injection EU CTD Ready
Fluconazole  vial 100mg, 200mg, 400mg injectables solution EU CTD Ready
Fluoxetine 20mg Capsules EU CTD Ready
Gabapentin 100mg / 300mg / 400mg capsules EU CTD Ready
Gabapentin 600mg / 800mg tablets EU CTD Ready
Gelatin sponge haemostatic sponge EU CTD Ready
Gemcitabine injectable solution EU CTD under development
Gemcitabine 200mg, 1gr lyophilized EU CTD Ready
Gemcitabine 200mg, 1000mg Trokensubstanz EU CTD Ready
Glibenclamide 1.25 mg, 2.5 mg, 5mg tabl. EU CTD Ready
Gliclazide  80mg tablets EU CTD Ready
Glimepiride 1-2-3-4 mg Tablets EU CTD ready
Glucosamine 1.5mg tablets EU CTD Ready
Granisentron inf. Sol. Syrup EU CTD under development
Granisetron 1mg, 2mg Tablets EU CTD Ready
Hypromellose  10ml & 5x6x0.5ml PL 15872/0005 eye drops EU CTD Ready
Ibuprofen  200,400,600 mg Tablets EU CTD Ready
Interferon Alfa 2a 3,4,5,9 MIU lyophilized EU CTD Ready
Interferon Alfa 2b 3,5 MIU  lyophilized EU CTD Ready
Irbesartan 75 mg, 150mg, 300mg tabl. EU CTD Ready
Irinotecan 100mg solution for injection EU CTD Ready
Irinotecan 40mg, 100mg Solution for infusion EU CTD Ready
Iron (protein acetyl aspartilate) 800 mg  drinkable vials EU CTD Ready
Iron succrose 20 mg / ml inj. EU CTD Ready
Isoflavone 100mg Capsules EU CTD Ready
Itraconazole 100 mg caps. EU CTD Ready
Ketoconazole 2% shampoo EU CTD Ready
Ketorolac 10mg sublingual tablet EU CTD Ready
Leflunomide 10mg / 20mg / 100mg coated tablets EU CTD Q3 / 08
Letrozole 2.5mg tablets EU CTD Ready
Levetiracetam 250mg / 500mg / 750mg / 1000mg coated tablets EU CTD Ready
Levoctrizine 5 mg Tablets EU CTD  Ready
Levodopa / Carbidopa 200 / 50 mg ER tabl. EU CTD Ready
Levofloxacin 250mg / 500mg tablets EU CTD Ready
Levofloxacin 5mg/ml injectables EU CTD Ready
Levonorgestrel 1.5mg tablets EU CTD Ready
Lisinopril 2.5 mg, 5mg, 10mg, 20mg tabl. EU CTD Ready
Lisinopril / HCT 10/12.5mg, 20/12.5mg Tablets EU CTD Ready
Loratadine 10mg Tablets EU CTD Ready
Loratadine 10mg syrup EU CTD Ready
Loratadine & Pseudofedrin 5mg & 120mg slow release capsule EU CTD Ready
Losartan 25, 50, 100mg tablets EU CTD Ready
Losartan + HCTZ  50mg + 12.5mg, 100 + 12.5mg,100mg + 25mg tablets EU CTD Ready
Mefenamic Acid 50 mg/ 5 ml susp. EU CTD Ready
Meloxicam 7.5 mg, 10mg tabl. EU CTD Ready
Melphalan 50 mg lyophilized EU CTD Ready
Memantine 10mg / 20mg / 100mg tablets EU CTD Q4 / 08
Meropenem 500 mg, 1000mg inj. EU CTD Ready
Metformin 500, 850mg Tablets EU CTD Ready
Methotrexate 25,50,100, 500,1000,5000mg Concentrate for infusion EU CTD Ready
Metoclopramid 10mg sublingual tablet EU CTD Ready
Metronidazol 400mg Tablets EU CTD Ready
Metronidazole 200 mg, 400mg tabl. EU CTD Ready
Mirtazapine 7.5mg, 15mg, 30mg, 45mg tablets EU CTD Ready
Mitomycin 2,5,10,20mg Powder for injection EU CTD Ready
Molgramostin 150mcg, 300mcg lyophilized EU CTD Ready
Mometasone Furoate 0.10% oint. EU CTD Ready
Mycophenolate Mofetil 250mg capsules EU CTD Q3 / 08
Nateglinide 60mg / 120mg / 180mg tablets EU CTD Q3 / 08
Nifedipine 30mg & 60mg sustained release tablets EU CTD Ready
Nimesulide 100mg, 200mg tablets EU CTD Ready
Olanzapine 5 / 7.5 / 10mg tablets EU CTD Ready
Olanzapine 2.5, 5, 7.5,10,15,20mg Tablets EU CTD Ready
Omeprazole 20, 40mg Capsules EU CTD Ready
Omeprazole 40 mg inj. EU CTD Ready
Ondansentron tablets, syrup, inj, s.o EU CTD Ready
Ondansetron 4mg, 8mg Film coated tablets EU CTD Ready
Ondansetron 4mg, 8mg Orodispersible tabs EU CTD Ready
Ondansetron  8mg / 4ml vial perfusion solution EU CTD Ready
Oseltamivir 75mg capsules EU CTD Ready
Oxaliplatin 50mg, 100mg Powder for injection EU CTD Ready
Oxcarbazepine 300, 600mg tablets EU CTD Ready
Oxybutynin 20mg, 30mg sustained release tablets EU CTD Ready
Paclitaxel 30, 100, 300mg Solution for injection EU CTD Ready
Pantoprazol 20mg, 40mg tablets EU CTD Ready
Pantoprazole 40 mg inj. EU CTD Ready
Paracetamol 1g Effervescent tablets EU CTD Ready
Paracetamol  500 mg caplets EU CTD Ready
Paracetamol + Tramadol 325 + 75 mg Tablets EU CTD  Ready
Paroxetine 20 mg, 30mg tabl. EU CTD Ready
Perindopril 2 mg, 4mg, 8mg tabl. EU CTD Ready
Pioglitazone 15, 30, 45mg tablets EU CTD Q4 / 08
Piracetam  EU CTD Ready
Pravastatin 10mg / 20mg / 40mg tablets EU CTD Ready
Quetiapine 25,100,200,300mg Film coated tablets EU CTD Ready
Raloxifene 60mg   tablets EU CTD Q4 / 08
Ramipril 1.25,2.5,10 mg tablets EU CTD under development
Ranitidine 150mg / 300mg tablets EU CTD Ready
Ribavirin 200 mg tabl. EU CTD Ready
Risedronate 35 mg coat. tabl. EU CTD Ready
Risperidone 0.25 mg, 0.5mg, 1mg, 2mg, 3mg, 4mg, 6mg tabl. EU CTD Ready
Ropinirole 0.25mg / 0.5mg / 1mg / 2mg / 5mg tablets EU CTD Q4 / 08
Roxithromycin 150 mg, 300mg film.coat.tabl. EU CTD Ready
Secnidazole 750mg bitterless suspension EU CTD Ready
Sertraline  25mg, 50mg, 100mg Capsules EU CTD Ready
Sertraline  50mg / 100mg tablets EU CTD Ready
Sibutramine  10mg / 15mg capsules EU CTD Q2 / 08
Sildenafil Citrate 25, 50, 100mg tablets EU CTD Ready
Simvastatin 5 mg, 10mg, 20mg, 40mg film.coat.tabl. EU CTD Ready
Sodium Cromoglicate 2% w/v 13.5ml eye drops EU CTD Ready
Spiramycin Metronidazole Bi 1.5MIU-250mg tablets EU CTD Ready
Spironolactone 50mg, 100mg Tablets EU CTD Ready
Sulodexide 250 uls soft gel caps. EU CTD Ready
Sulodexide 600 uls - 2 ml inj. EU CTD Ready
Sulphasalazine  500 mg Tablets EU CTD Ready
Sumatriptan succinate 50 mg, 100mg tabl. EU CTD Ready
Tamoxifen 10,20,30,40mg Tablets EU CTD Ready
Tamsulosin 0.4mg Capsules EU CTD Ready
Terazosin 2mg, 5mg Tablets EU CTD Ready
Terbinafine 250mg tablets EU CTD Ready
Timolol 0.25% w/v 5ml PL 15872/001-0018 eye drops EU CTD Ready
Timolol 0.50% w/v 5ml PL 15872/002-0018 eye drops EU CTD Ready
Tolperison  EU CTD Ready
Topiramate 25mg / 50mg / 100mg / 200mg tablets EU CTD Ready
Tramadol 100 mg, 150mg, 200mg PR tabl. EU CTD Ready
Triflusal 300mg Capsules EU CTD Ready
Trimebutine 300mg Slow release tablet EU CTD Ready
Valaciclovir  500 mg, 1000mg tabl. EU CTD Ready
Valsartan 40mg / 80mg / 160mg tablets EU CTD Ready
Valsartan + HCTZ  80mg+12.5mg / 160mg+12.5mg / 160mg+25mg tablets EU CTD Q3 / 08
Venlafaxine SR 75, 150mg Capsules EU CTD Ready
Vinorelbine 10-50 mg / vial inectable solution EU CTD Ready
Zaleplon 5 mg, 10mg caps. EU CTD Ready
Zolendronic acid 4 mg inj. EU CTD Ready

Products are not offered for sale in countries where Patent exisits. Buyers are completely responsible for patent evaluation before purhcase of the product. Products protected by valid patents are not offered for sale in countries where the sale of such products constitutes a patent infringement and its liability is at buyer's risk. . Products currently covered by valid US Patents are offered for R &D use in accordance with 35 USC 271 +A13(1) . Information provided above is on " as is basis " and cannot be considered valid, unless confirmed by the company. The products offered for sale are subject to various conditions of availability . To confirm availability and conditions of sale , kindly contact us. Products are availabe to sales subject to various conditions.

 
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