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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 |