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Strides Pharma Science announced that its step-down wholly owned subsidiary, Strides Pharma Global, Singapore, received tentative approval for Diclofenac Potassium softgel capsules, 25 mg from the United States Food & Drug Administration (USFDA).
The product is a generic version of Zipsor Capsules, 25 mg, of Assertio Therapeutics, Inc. It is a nonsteroidal anti-inflammatory drug used to relieve pain and swelling from various mild to moderate painful conditions. It is used to treat muscle aches, backaches, dental pain, menstrual cramps, and sports injuries.
According to IOVIA MAT data, the US market for Diclofenac Potassium softgel capsules, 25 mg is approximately $30 million. Strides can launch the product earliest by September 2022 based on terms of settlement. On receiving full approval, the product will be manufactured at the companys oral dosage facility at Bangalore and marketed by Strides Pharma Inc in the US market.
The company has 102 cumulative ANDA filings with USFDA of which 67 ANDAs have been approved and 35 are pending approval.
Strides now has a large portfolio of softgel products which comprises of 11 approved products for the US markets along with a strong product pipeline cutting across several therapeutic segments. The announcement was made during market hours today, 4 December 2019.
On a consolidated basis, the drug maker reported a net profit of Rs 142.72 crore in Q2 September 2019 as against a net loss of Rs 12.01 crore in Q2 September 2018. Net sales rose 37.6% to Rs 715.09 crore in Q2 September 2019 over Q2 September 2018.
On the technical front, the stocks RSI (relative strength index) stood 47.78. The RSI oscillates between zero and 100. Traditionally the RSI is considered overbought when above 70 and oversold when below 30.
The stock was trading above its 50-day placed at Rs 364.73 but below its 200-day moving average (DMA) placed at Rs 406.10.
Strides Pharma Science is a global pharmaceutical company.
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