Shilpa Medicare has received United States Food and Drug Administration (USFDA) s tentative approval for its abbreviated new drug application (ANDA), apremilast tablets, 10 mg, 20 mg, and 30 mg.
The ANDA was filed as First to File submission on NCE -1 date to seek eligibility for 180 days exclusivity.
Apremilast tablets, 10 mg, 20 mg, and 30 mg is a generic equivalent of reference listed drug (RLD) OTEZLA of Celgene, used in the treatment of psoriatic arthritis as recommended in the label approved by FDA.
According to IQVIA MAT Q2 2020 data, the US market for apremilast tablets, 10 mg, 20 mg, and 30 mg is approximately US $2.4 billion.
Shilpa Medicare is a global brand in manufacturing and supplying of affordable API and formulation globally in different regulated markets.
Read more about Wipro, Heranba Industries, Unichem Laboratories in focus on Business Standard. Wipro announced that it has signed an agreement to acquire Capco, a global management and technology consultancy providing digital, consulting and technology services to financial institutions in the Americas, Europe and the Asia Pacific. The
Baboró International Arts Festival for Children, Druid, and the Galway International Arts Festival have been shortlisted for the prestigious Business to Arts Awards.
Vivimed Labs announced that its FDF manufacturing facility located in Jeedimetla, near Hyderabad inspected in August 2017 by the Ukraine ministry of Health, has been approved and accredited with GMP Certification effective September 2017 and same has been renewed upto 04 February 2022 on 10 February 2021.
Ukraine is a member Country of PICS, whose members include many European Countries.
The GMP approval extension also includes 5 new product registrations.
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Unichem Laboratories has received ANDA approval
for its Guanfacine Tablets, USP 1 mg and 2 mg from the United States Food and Drug
Administration (USFDA) to market a generic version of TENEX (Guanfacine) Tablets 1
mg and 2 mg of Promius Pharma LLC.
Guanfacine Tablets are indicated in the management of hypertension.
The product will
be commercialized from Unichem s Ghaziabad Plant.
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(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.) Dear Reader,
Business Standard has always strived hard to provide up-to-date information and commentary on developments that are of interest to you and have wider political and economic implications for the country and the world. Your encouragement and constant feedback on how to improve our offering have only made our resolve and commitment to these ideals stronger. Even during these difficult times arising out of Covid-19, we continue to remain commi