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Strides Pharma gets USFDA nod to Butalbital, Acetaminophen, Caffeine tablets to treat headache

Ruchika SharmaWritten by Ruchika Sharma Published On 2020-09-23T12:45:18+05:30  |  Updated On 23 Sep 2020 7:15 AM GMT
Strides Pharma gets USFDA nod to Butalbital, Acetaminophen, Caffeine tablets to treat headache
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Bengaluru: Strides Pharma Science Limited has recently announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Butalbital, Acetaminophen, and Caffeine Tablets USP, 50 mg/325 mg/40 mg from the United States Food & Drug Administration (USFDA). The product is bioequivalent and therapeutically equivalent to the...

Bengaluru: Strides Pharma Science Limited has recently announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Butalbital, Acetaminophen, and Caffeine Tablets USP, 50 mg/325 mg/40 mg from the United States Food & Drug Administration (USFDA).

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Butalbital, Acetaminophen, and Caffeine Tablets USP, 50 mg/325 mg/40 mg, of Actavis Laboratories FL, Inc.

Butalbital, acetaminophen, and caffeine tablets USP is indicated for the relief of the symptom complex of tension (or muscle contraction) headache.

According to IQVIA MAT July 2020 data, the US market for Butalbital, Acetaminophen, and Caffeine Tablets USP, 50 mg/325 mg/40 mg is approximately US$ 40 Mn.

The product will be marketed by Strides Pharma Inc. in the US market.

The company has 126 cumulative ANDA filings with USFDA of which 91 ANDAs have been approved and 35 are pending approval.

Read also: Strides Pharma to buy 54 percent stake in SteriScience for Rs 135 crore

Strides is a global pharmaceutical company headquartered in Bangalore, India. The Company mainly operates in the regulated markets and has an "in Africa for Africa" strategy along with an institutional business to service donor‐funded markets.

The Company's global manufacturing sites are located in India‐ Bangalore (two locations), Pondicherry, and Chennai, Singapore, Italy‐ Milan, Kenya‐ Nairobi and United States‐Florida.

Read also: Strides Pharma anti-inflammatory drug Prednisone gets USFDA nod




strides pharmastrides pharma newsusfdabutalbitalacetaminophencaffeine tabletstension headachestrides pharma science
Ruchika Sharma
Ruchika Sharma

    M.Com

    Ruchika joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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