Indoco files DMF with USFDA and set for US Opthal market

Indoco files DMF with USFDA and set for US Opthal market. Indoco Remedies Limited, a global pharmaceutical company, is set for the US Opthal market, filing its first Ophthalmic Drug Master File (DMF) with USFDA for Brimonidine, an anti-glaucoma drug.
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Dec 11, 2008, 04.47 PM | Source: Moneycontrol.com

Indoco files DMF with USFDA and set for US Opthal market

Indoco files DMF with USFDA and set for US Opthal market. Indoco Remedies Limited, a global pharmaceutical company, is set for the US Opthal market, filing its first Ophthalmic Drug Master File (DMF) with USFDA for Brimonidine, an anti-glaucoma drug.

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Indoco files DMF with USFDA and set for US Opthal market

Indoco files DMF with USFDA and set for US Opthal market. Indoco Remedies Limited, a global pharmaceutical company, is set for the US Opthal market, filing its first Ophthalmic Drug Master File (DMF) with USFDA for Brimonidine, an anti-glaucoma drug.

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Indoco Remedies Limited, a global pharmaceutical company, is set for the US Opthal market, filing its first Ophthalmic Drug Master File (DMF) with USFDA for Brimonidine, an anti-glaucoma drug. Indoco intends to file a total of five DMFs in the Ophthalmology space with USFDA over the next few quarters thereby translating into a huge step forward towards targeting the US Opthal market. This is the fifth DMF filed by Indoco in the current year.

 

Commenting on the DMF filing, Ms. Aditi Kare Panandikar, Executive Director, Indoco Remedies Limited, said that “Opthal has been a focus area for Indoco while it looks at US generic market and filing this DMF therefore becomes the first concrete step. It is imperative to be vertically integrated when you submit US ANDAs. Indoco is steadfast in its aggressive program to increase the number of Opthalmic products in its generic division.”

 

USFDA inspection at Indoco’s Rabale, kilo manufacturing facility is expected to be completed before the end of this financial year. The previous four DMF’s filed this year in US and Europe were for anti-diabetics, NSAID, anti-biotic and anti-spasmodic.

 

Sourced From: Indoco Remedies Ltd

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Indoco files DMF with USFDA and set for US Opthal market
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