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 Active Pharmaceutical Ingredients - Regulatory
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
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Interactions with various Regulatory Bodies |
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Preparation and filing of DMF’s of MSN API’s and address to queries from Regulatory Bodies |
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Assisting Regulatory Authorities during Audits |
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Chemistry, manufacturing, and control documentation to support IND, NDA’s and ANDA’s |
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MSN Regulatory Filings
| Product |
USDMF Number |
EDMF Number |
CEP Number |
CEP Number |
Europe Regulatory Procedures |
| Alfuzosin Hydrochloride |
20867 |
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CEP 2006-208 / Granted |
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| Aprepitant |
Q4 – 2009 |
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| Atorvastatin Calcium (Amorphous) |
22785 |
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| Atorvastatin Calcium (Form-1) |
21892 |
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| Bosentan |
Q4 – 2009 |
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| Carbinoxamine Maleate |
21301 |
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| Clopidogrel Besylate |
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NA |
| Clopidogrel Bisulfate (Form-1) |
21309 |
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Q4 – 2009 |
NA |
| Darifenacin Hydrobromide |
22225 |
NA |
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| Duloxetine Hydrochloride |
20996 |
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| Dutasteride |
Q4 – 2009 |
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| Eplerenone |
Q4 – 2009 |
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| Ezetimibe |
21554 |
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DCP |
| Finasteride |
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CEP 2008-024 / Granted |
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NA & MRP |
| Finasteride USP |
21276 |
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| Ketorolac Trometamol |
21276 |
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CEP 2008-144 |
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| Ketorolac Tromethamine USP |
21693 |
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| Memantine Hydrochloride |
22112 |
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CEP 2008-144 |
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DCP & NA |
| Montelukast Sodium |
20580 / 22484 |
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CEP 2008-144 |
2008-142 |
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| Moxifloxacin |
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| Moxifloxacin HCl [Monohydrate] |
20755 |
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CEP 2007-355 / Granted |
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| Olmesartan Medoxomil |
Q4 – 2009 |
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| Paliperidone |
Q4 – 2009 |
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| Pantoprazole Sodium |
20850 |
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| Pitavastatin Calcium |
Q4 – 2009 |
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| Pregabalin |
22111 |
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2009-030 |
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| Ranolazine |
22350 |
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| Rosuvastatin Calcium |
20712 |
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2008-008 / 2009-040 |
DCP & NA |
| Solifenacin succinate |
Q4 – 2009 |
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| Sumatriptan Succinate |
22482 |
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CEP 2009-096 |
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| Telmisartan |
22731 |
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CEP 2009-108 |
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| Terbinafine Hydrochloride |
20413 |
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CEP 2006-157 / Granted |
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NA |
| Voriconazole |
21523 |
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2009-077 |
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