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The company said that it will be engaging with the agency and is fully committed in resolving this issue at the earliest. The firm added that it is committed in maintaining the highest standards of compliances and quality manufacturing across all its facilities.
Shilpa Medicare believes that the warning letter will have minimum impact of disruption of supplies and the existing revenues from operations of this facility.
The company currently has three manufacturing facilities approved by the US Food and Drug Administration (USFDA) - one formulation facility and two active pharmaceutical ingredient (API) facilities. None of these facilities except Jadcherla has any outstanding issues with the USFDA at this point of time.
The Jadcherla facility is designed for contract manufacturing and dosage developments of potent products (including oncology products) for various regulatory markets.
Shilpa Medicare is a global brand in manufacturing and supplying of affordable API and formulation globally in different regulated markets.
The drug maker's consolidated net profit surged 474.7% to Rs 85.98 crore on 38.4% jump in net sales to Rs 222.86 crore in Q1 June 2020 over Q1 June 2019.
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