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NEW DELHI: Morepen Laboratories has filed a US Drug Master File (DMF) for the new polymorphic form VI of Atorvastatin Calcium, a cholesterol-lowering drug, with the Food and Drug Administration (FDA). It is also in the process of submitting the same for the European markets.

Earlier it had filed a patent for this drug in the US, Canada, and 31 other European countries.

Atorvastatin Calcium (Pfizer's Lipitor) is the largest selling drug in the world today with a market size of $9 billion.

Morepen said that it has the proprietary technology to manufacture pure and stable crystalline polymorphic Form VI and amorphous forms of these drugs and also has full DMF for the same.

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