Strides Pharma Science announced that itsstep-down wholly owned subsidiary, Strides Pharma Global, Singapore, has receivedapproval for Ursodiol Capsules USP, 300 mg from the United States Food & Drug Administration(USFDA). The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug(RLD), Actigall® Capsules, 300 mg, of Allergan Sales, LLC.

According to IQVIA MAT November 2020 data, the US market for Ursodiol Capsules USP, 300 mg isapproximately US$ 45 Mn. The product will be manufactured at the company's facility at Bengaluru andwill be marketed by Strides Pharma Inc. in the US market.

The company has 127 cumulative ANDA filings with USFDA of which 96 ANDAs have been approvedand 31 are pending approval

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Strides Pharma Science on Monday announced that its step-down wholly owned subsidiary, Strides Pharma Global, Singapore has received approval for Ursodiol capsules from the United States Food & Drug Administration (USFDA).

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Actigall capsules of Allergan Sales. Ursodiol tablets are indicated for the treatment of patients with Primary Biliary Cirrhosis (PBC).

According to IQVIA MAT November 2020 data, the US market for Ursodiol capsules is approximately $45 million. The product will be manufactured at the company's facility at Bengaluru and will be marketed by Strides Pharma Inc. in the US market.

Strides Pharma Science is a global pharmaceutical company. It focuses on difficult to manufacture products that are sold in over 100 countries. The company has 127 cumulative ANDA filings with USFDA of which 94 ANDAs have been approved and 33 are pending approval.

Shares of Strides Pharma were trading 1.06% lower at Rs 838.75 on BSE. Meanwhile, the S&P BSE Sensex was down 30.71 points or 0.06% at 48,847.83.

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Strides Pharma Science announced that India Ratings and Research (Ind-Ra) vide its letter dated 21 January 2021 has upgraded company's Long-Term Issuer Rating to 'IND A+' with a Stable Outlook from 'IND A' previously.

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In a BSE filing made before market hours today, the company said that its wholly owned subsidiary, Strides Pharma Global, Singapore, has received approval for Emtricitabine and Tenofovir Disoproxil Fumarate tablets, 200 mg/300 mg from the United States Food & Drug Administration (US FDA).

The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Truvada tablets, 200 mg/300 mg, of Gilead Sciences. The product will be manufactured at the company's facility at Bengaluru and will be marketed by Strides Pharma Inc. in the US market.

According to IQVIA MAT November 2020 data, the US market for Emtricitabine and Tenofovir Disoproxil Fumarate tablets, 200 mg/300 mg is approximately $2.4 billion.

Emtricitabine and tenofovir belongs to class of medications called nucleoside and nucleotide reverse transcriptase inhibitors. The combination of Emtricitabine and Tenofovir slows down the spread of HIV in the body and is used along with other medications to treat HIV in adults and children.

Strides Pharma Science is a global pharmaceutical company. It focuses on difficult to manufacture products that are sold in over 100 countries. The company has 127 cumulative ANDA filings with USFDA of which 94 ANDAs have been approved and 33 are pending approval.

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