| MANAGEMENT DISCUSSION AND ANALYSIS |
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| In all, across plants, 13 international approvals have been received including those from the USFDA and UKMHRA. |
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| At our Halol plant, over the years, regulatory approvals have been received from a number of agencies, such as the USFDA, UKMHRA, ANVISA, IMVIMA, South African MCC, to name a few. The USFDA approval last year of the injectable and spray areas points to the high level of quality compliance- at the time of writing, this is the only site in India with injectable approval. Our Dadra formulations plant is being prepared for submission to the USFDA this year. |
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| These approvals point to an accomplished quality team, which contributes to a product right from the process development stage, and a team that regularly updates its skills to ensure that the latest standards are complied with. |
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| The central quality team works closely with other partners such as vendors, suppliers of material, packaging and machinery to ensure that quality standards are met. All quality policies are duly detailed and upgraded periodically. Ongoing training programs ensure that these policies are understood across the manufacturing chain. A quick response system that updates quality procedures in line with changing regulatory requirements is in place. |
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