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- Latest API's ,Pharma Intermediates, New Molecules , Formulations, Custom Synthesis, DMFs/Dossiers Preparation from Nivon Pharma (India)

Nivon Specialties (India) specializes in marketing wide range of Latest Active Pharmaceutical Ingredients API, sourcing new molecules, Formulation, Custom Synthesis, Contract manufacturing, Pharma Intermediates , Dossier/DMF preparation to the worldwide market, manufactured in GMP approved plants.
We offer from W.H.O. G.M.P. manufacturing facilities matching International standards. Our policy of strict adherence to demanding delivery schedules is complemented with high degree of innovation, high quality products and excellent service.
We are very strong in the following APIs and its formulations and can support you with DMF / Dossiers , Manufacturing License (Form 25 and Form 28) / WHO GMP Certificate / Free Sales Certificate /FDA Product Permission / COPP / ISO / COA
We also have BA/BE studies ready for 55 products and more are to be added shortly.

API’s :
Alendronate, Adapalene, Atorvastatin, Amlodipine , Ambroxol, Amodiaquine, Ambazone, Allantoin, Ascorbyl palmitate, AmylMetaCresol, Allopurinol, Atenolol, Artemether,Bromhexine, Bifonazole, Budesonide, Betamethasone, Cefexime, Cetirizine, Carvedilol, Cyproheptadiene, Clopidogrel, Cefuroxime, Cyclandelate, Cetrimide, Cilostazol, Capecitabine, Calcitriol, Chlorzoxazone, Cilazapril, Cinitapride, Domperidone, Desloratadine, Doxylamine, Dorzolamide, Diacerein , Donepezil, Diphenhydramine, Esomeprazole, Eprosartan, Ezetimibe, Erythromycin, Ebastine, Ethopabate, Fluticasone, Fluconazole, Fexofenadine, Furosemide, Formoterol, Fenoprofen, Felodipine, Fosinopril, Fluocinolone, Glibenclamide, Gemcitabine, Glimepiride, Granisetron, Glipizide, Gabapentin, Glycopyrrolate, Glucosamine,Gefitinib, Galantamine, Halquinol, Hydralazine, Itopride, Itraconazole, Isoxsuprine, Ibuprofen, Isosorbide, Ivermectin, Irbesartan, Ipratropium , Irinotecan , Imatinib , Ketoconazole, Loperamide , Lansoprazole, Lisinopril. Lamotrigine, Loratadine, Losartan, Levosalbutamol, lercanidipine, Levocetirizine, Lumefantrine, Lacosamide , Latanoprost‏, lenalidomide, Lovastatin, Meloxicam, Mometasone, Montelukast, Mebeverine, Metoprolol , Miconazole, Moxifloxacin, Methocarbamol, Metoclopramide, Mebendazole, Metformin, Mefenamic, Nebivolol, Niclosamide, Nevirapine, Nateglinide, Nalidixic, Orlistat, Omeprazole, Ondansetron, Ornidazole, Oxyclozanide, Olmesartan, Pioglitazone, Pantoprazole, Pregabalin, Phenylepherine, Pamidronate, Perindopril, Prasugrel, Piroxicam, Proguanil, Quinine, Ramipril, Rabeprazole, Rosiglitazone, Rosuvastatin, Rafoxanide, Rizatriptan, Rocuronium,Sildenafil, Salbutamol, Salmeterol, Sumatriptan, Simvastatin, Sodium Cromoglycate, Simethicone , Solifenacin, Sitagliptin, Terbinafine, Trimetazidine Triprolidine, Tadalafil, Timolol , Trioxsalen, Tamsulosin, Telmisartan, Tamoxifen, Trandolapril, Tazarotene, Tenoxicam, Temozolomide, Tolnaftate, Terbutaline, Triamcinolone, Voriconazole, Valsartan, Valacyclovir, Vinblastine, Vincristine, Vardenafil, Warfarin,

Intermediate’s:

Amlodipine Intermediate ( Phthaloyl Amlodipine )
Bromo Compound ( 2-Acetoxy-5-(2-Bromoacetyl)-1-Benzylacetate) / Bromobenzene
Clopidogrel sulfate intermediates.
Chelating Agent : (p-Toluenesulfonic acid (PTSA) / p-Toluenesulfonyl Chloride (TOSYL
CHLORIDE) / Ethyl Para Toulene Sulfonate.)
Carvedilol Intermediate : (CAS 51997-51-4 / CAS 1836-62-0 )
Domperidone Intermediate ( N Carbethoxy-4-Piperidone / Domperidone Base)
Eprosartan ( Thiophene-2-Aldehyde)
Fexofenadine Intermediate (CAS NO: )
Fluconazole Intermediate.
Formoterol Intermediates (Benzyl Formoterol / CAS# 43229-01-2 / CAS# 43229-65-8 )
Imatinib Intermediate ( N-(2-Methyl-5-aminophenyl)-4-(3-Pyridyl)-2-Pyrimidine /
4-(4-methyl-1-piperazinyl)methyl benzoic acid dihydrochloride )
Isoxsuprine Hcl Intermediate (4- Hydroxy Propiophenone / 4- Benzyloxy
Propiophenone / 4’-Benzyloxy-2-Bromo-Propiophenone.)
Gefitinib Intermediate
Loratadine Intermediate ( Methyl Loratadine / 8-Chloro-5,6-dihydro-11H-
benzo[5,6]cyclohepta[1,2-b]pyridin-11-one
Lamotrigine Intermediate (Schiff Base, DCBN, 2,3 Dichloro Benzoyl Nitrile)
Lansoprazole Intermediates
Losartan Intermediate (Trityl Losartan )
N Methyl-4-piperidone & Piperdione derivatives
Mono Chloro Acetic Acid 99% min
Microcrystalline Cellulose PH 101
Montelukast Intermediates
Methyl Iodide
Miconazole Base
Nebivolol Intermediate ( 6 Fluorocarboxylic Acid)
N,N,DiethylBenzamide (Mosquito repellent)
Pioglitazone Intermediates (5-Ethyl Pyridine-2-Ethanol / 2,4-Thiazolidinedione)
Piperazine Citrate
Rabeprazole Intermediate ( 2-Mercapto Benzimidazole / 2,3-dimethyl-4-nitropyridine N-oxide /
Methyl Mercapto Benzimidazole,2Mercapto-5-
MethoxyBenzimidazole)
Ritodrine Hcl ( 1-(4-Benzyloxyphenyl)-2-(4-hydroxy phenethylamino) Propanone HCL )
Salmeterol Xinafoate Intermediate: 4-Phenyl-1-Butanol /4-(6-Bromohexyloxy)butylbenzen/N-
Benzyl-6-(4 Benzyl butoxy) hexylamine./ 1-phenylpiperazine /
Salmeterol Base).
Salbutamol Intermediate (Salbutamol Base, O-Benzyl Salbutamol )
Sildenafil Intermediate (4-Amino-1-methyl-3-propylpyrazole-5-carboxamide HCL )
Strontium Ranelate
Stannous Oxide / Stannic Oxide
Tributyl tin oxide / Dibutyl tin oxide
Telmisartan Intermediate : (Methyl 4(bromomethyl) (1,1biphenyl)-2-Carboxylate] .
Triethyl Amine Hcl ( Pharma Intermediate)
Timolol Maleate Intermediate : (3-Chloro-4-Morpholino-1,2,5-Thiadiazole / Tosyl Chloride /
PTSA, Timolol Base )


Formulation :
Alendronate Sodium 70 mg / Atorvastatin Calcium 10 mg / Albendazole Tabs / Ascorbic acid tab( vitamin c) Chewable / Amoxicillin 250 mg + combinations / Azithromycin / Atenolol tabs / Amlodipine Besilate Tabs / Ceftriaxone 250mg & 1000 mg Inj / Cefuroxime susp , vial / Cefotaxime 125mg & 1000 mg Inj./ Ciprofloxacin Tabs / Carvedilol Tabs / Clopidogrel Bisulphate tabs / Clarithromycin tab / Desloratadine Tabs / Drotaverin 40 mg / Dapoxetine 60 mg tab / Dextrose 5% + Sodium Chloride 0.18% /Fluconazole caps / Glucosamin HCL 500mg + Chondroitin sulphate 400mg / Granisetron Inj Isotretinoin Capsules / Metformin 500 mg + Gliclazide 80 mg / Multivitamin + mineral + amino acids tabs / Moxifloxacin 400 mg / Orlistat 120 mg caps / ORS (oral rehydration solutions/salts) / Omeprazole 20 mg caps / Pantoprazole 40 mg / Pioglitazone 15/30/45 mg./ Paclitaxel inj / Sildenafil 100/150 mg tabs / sildenafil 100mg + Dapoxetine 60mg / Sildenafil Jelly / Tadalafil 20 mg/40 mg tabs / Tadalafil 20mg + Dapoxetin 60 mg / Trimetazidine 35 mg tabs / Vardenafil 20 mg tabs + Dapoxetine 60 mg
We have following dossiers in CTD format ready and can also make on your required products with timelines.
We also have UKMHRA formulation unit form where we can supply finished formulation.
CTD list
1.Levofloxacin tab 250 mg/500 mg/750 mg.
2.Azithromycin tab 250 mg/500 mg.
3.Esomeprazole cap 20 mg.
BA/BE list
1.Rosuvastatin 20 mg tab
2.Trimetazidine MR 35 mg tab
3.Cotrimoxazole 400 mg tab
4.Clopidogrel 75 mg tab
5.Cetrizine 10 mg cap
6.Attorvastatin 10 mg tab
7.Lansoprazole delayed release 30 mg cap


(For compiled & Complete list , check our website )

Direct Compressible (DC) Grade Material:
Tadalafil DC Grade / Sildenafil DC Grade


From China:

Albendazole

From Ukraine:


Dioxidine,Nifuratel,Potassium orotate,Nitrazol,Miramistin,Mebhydrolin napadisylate,Luminol sodium,N-Acridone acetic acid, Chinoxidine


Impurity / Reference standards / working standards can be provided


All freelancers / Indenting agents/ Commission agents are requested to contact us, we will cover their interest and will also provide customer protection agreement

Pellets :
Esomepraole mg pellets / Orlistat pellets 50% / Tamsulosin Pellets / Mebeverine Hcl Pellets 40% upto 70% / Omeprazole pellets 7.5% , 8.5% / Pantoprazole pellets 22.5% / Lansoprazole Pellets /

Dossiers Preparation: CTD format Dossier for Regulated and Semi-Regulated Market

Custom Synthesis & Contract Mfg:

Reactions which can be carried at Dombivali Plant:

Fridel craft reactions/ Cyclizations / Condensations / Saponification /Oxidation /Esterfication/High Vacuum Distillation/Amidation

Patents:

a) 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 buyers risk.
b) Products currently covered by valid U.S patents. are offered for R & D use in accordance with 35 USC 271(e) + A13( 1)
c) Product list is covered under “Bolar Provision” and only non commercial samples for R & D are available.

M/s Nivon Specialties (India)
=========================
(API's, Pharma Int., New Molecules,Formulation & Custom Synthesis)
(Established Since 1999 in Mumbai & Reg. with Trademark Authorities)
Vashi, Navi Mumbai, Maharashtra.
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