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Strides Pharma receives USFDA approval for Ursodiol Capsules

Strides Pharma Science announced that its
step-down wholly owned subsidiary, Strides Pharma Global, Singapore, has received
approval 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 is
approximately US$ 45 Mn. The product will be manufactured at the company s facility at Bengaluru and
will 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 approved ....

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Alembic Pharmaceuticals receives USFDA approval for Asenapine Sublingual Tablets

Alembic Pharmaceuticals announced it has received approval
from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Asenapine Sublingual Tablets, 5 mg and 10 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Saphris Sublingual Tablets, 5 mg and 10 mg, of Allergan Sales, LLC (Allergan).
Asenapine is an atypical antipsychotic indicated for bipolar I disorder as adjunctive treatment to
lithium or valproate in adults.
Alembic had previously received tentative approval for this ANDA. Alembic was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification and hence is eligible for 180 days of shared exclusivity. ....

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Alembic Pharma gains after USFDA approval for asenapine sublingual tablets

Alembic Pharmaceuticals rose 1.32% to Rs 1,074.30 after the company announced that it received approval from the US drug regulator for its Abbreviated New Drug Application (ANDA) Asenapine Sublingual Tablets.The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Saphris Sublingual Tablets, 5 mg and 10 mg, of Allergan Sales, LLC (Allergan).
Asenapine is an atypical antipsychotic indicated for bipolar I disorder as adjunctive treatment to lithium or valproate in adults. Alembic had previously received tentative approval for this ANDA.
Alembic was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification and hence is eligible for 180 days of shared exclusivity. ....

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Alembic Pharmaceuticals announces USFDA Final Approval for Asenapine Sublingual Tablets, 5 mg and 10 mg

Alembic Pharmaceuticals announces USFDA Final Approval for Asenapine Sublingual Tablets, 5 mg and 10 mg
equitybulls.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from equitybulls.com Daily Mail and Mail on Sunday newspapers.

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Shares turn range bound; PSU stocks rally

Shares turn range bound; PSU stocks rally
business-standard.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from business-standard.com Daily Mail and Mail on Sunday newspapers.

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