MSN has well Qualified RA team who supports various customers throughout the World by providing Regulatory Guidance and Documents required for Regulatory Submission. RA has a vast exposure to various International Regulatory Guidelines, regulations and pharmacopoeias and committed to stay at the forefront of the evolving regulations by working closely with regulatory agencies and industry association groups.
The Major Activities of the RA includes
•
Interactions with various Regulatory Bodies
•
Preparation and filing of DMF’s of MSN API’s and address to queries from Regulatory Bodies
•
Assisting Regulatory Authorities during Audits
•
Chemistry, manufacturing, and control documentation to support IND, NDA’s and ANDA’s
MSN Regulatory Filings
Product
Tech
Pack
DMF
Indian Patent
PCT
Therapeutic Category
Open
Part
EU
US
CEP
KOREA
Agomelatine
Anti Depressant
Alfuzosin Hydrochloride
Benign Prostatic Hyperplasia(BPH)
Aliskiren Hemifumarate
Anti Hypertensive
Almotriptan Maleate
Anti Migraine
Ambrisentan
*
Pulmonary Arterial Hypertension(PAH)
Apixaban*
Anti Coagulant
Aprepitant
*
Anti Emetics
Arformoterol
*
Anti Asthmatic
Ariplprazole
Anti Psychotic
Armodafinil
CNS Stimulant
Asenapine
Anti Psychotic
Atorvastatin Calcium(Amorphous)
Anti Hyper Lipoproteinemic
Atorvastatin Calcium(Form-I)
Azelastine
*
Anti Histaminic
Azilsartan Medoxomil*
Anti Hypertensive
Bazedoxifene Acetate*
*
Osteoporosis
Boceprevir
Hepatitis C
Bosentan
PAH
Carbinoxamine Maleate
Anti Histaminic
Carmoterol*
*
Anti Asthamatic
Cinacalcet
Anti Hyperthyroidism
Clevidipine
Anti Hypertensive
Clopidogrel Besylate
Clopidogrel Bisulfate Form I
*
Anti Thrombotic
Clopidogrel Bisulfate Form II
Dabigatran
Anti Coagulant
Dapoxetine
Premature Ejaculation
Darifenacin Hydrobromide
Anti Spasmodic
Darunavir Ethanolate
*
Anti Viral
Deferasirox
*
Iron Chelator
Desvenlafaxine
Anti Depressant
Dexlansoprazole AH/SH
Anti Ulcerative
Dronedarone
Anti Arrhythmic
Duloxetine Hydrochloride
Anti Depressant
Dutasteride
BPH
Eplerenone
Anti Hypertensive
Eprosartan
Eslicarbazepine Acetate
*
Anti Epileptic
Esmolol Hydrochloride
Anti Arrhythmic
Ezetimibe
Anti Hyper Lipoproteinemic
Febuxostat
*
Hyperuricemia and Gout
Fesoterodine*
*
Anti Muscarinic
Finasteride
BPH
Fingolimod Hyrochloride
Multiple Sclerosis
Formoterol
*
Anti Asthmatic
Fosaprepitant Dimeglumine
*
Anti Emetic
Gemifloxacin
Anti Bacterial
Ibudilast*
Anti Inflammatory
Iioperidone
Anti Psychotic
Ketorolac Tromethamine
Anti Inflammatory
Lacosamide
*
Anti Epileptic
Linagliptin
Anti Diabetic
Lurasidone
*
Anti Psychotic
Memantine Hydrochloride
Anti Prakinsonian
Milnacipran
*
Anti Depressant
Montelukast Sodium
Anti Asthmatic
Moxifloxacin Hydrochloride AH
*
Anti Bacterial
Moxifloxacin Hydrochloride MH
Nebivolol
Anti Hypertensive
Olmesartan Medoxomil
Olopatadine
Anti Histaminic
Oseltamivir Phosphate
*
Anti Viral
Paliperidone
Anti Psychotic
Paliperidone Palmitate
Palonosetron Hydrochloride*
Anti Emetic
Pantoprazole Sodium
Anti Ulcerative
Perindopril Erbumine
Anti Hypertensive
Pioglitazone
Anti Diabetic
Pitavastatin Calcium
*
Anti Hyper Lipoproteinemic
Posaconazole
Anti Fungal
Pramipexole
*
Anti Parkinsonian
Prasugrel
*
Anti Thombotic
Prazosin
Anti Hypertensive
Pregabalin
Anti Convulsant
Ramelteon
Insomnia
Ranolazine
**
Anti Hypertensive
Rivaroxaban*
*
Anti Thrombotic
Rivastigmine
Anti Alzheimer's
Roflumilast
Anti Asthmatic
Rosiglitazone Maleate/Succinate
Anti Diabetic
Rosuvastatin Calcium
Anti Hyper Lipoproteinemic
Rufinamide
Anti Convulsant
Salmeterol Xinofoate
*
Anti Asthmatic
Saxagliptin HCL MH*
*
Anti Diabetic
Sildenalil Citrate
Erectile Dysfunction/PAH
Silodosin
BPH
Sitagliptin Phosphate
Anti Diabetic
Solifenacin Succinate
Anti Spasmodic
Sumatriptan Succinate
Anti Migraine
Tadalafil
Erectile Dysfunction/PAH
Tapentadol
Analgesic
Teleprevir*
Hepatitis C
Telmisartan
Anti Hypertensive
Terbinafine Hydrochloride
Anti Fungal
Ticagrelor*
*
Anti Thrombotic
Tofacitinib*
Rheumatoid Arthritis
Tolterodine Taratrate
BPH
Tolvaptan
Inappropriate ADH Syndrome
Topiramate
*
*
Anti Convulsant
Trandolapril
Anti Hypertensive
Trospium Chloride
*
BPH
Vigabatrin*
*
Anti Epileptic
Vilazodone
*
Anti Depressant
Vildagliptin
*
Anti Diabetic
Voriconazole
Anti Fungal
Zileuton
Anti Asthmatic
Note: Above products will NOT be supplied to countries in which these could be in conflict with existing patents and the above products
will only be offered to the extent that they will be used to obtain marketing approval and not for any commercial use. However, the final responsibility lies exclusively with the buyer.
