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Unichem Labs gets tentative US FDA approval for Sitagliptin Tablets USP
expresspharma
July 12, 2021
Sitagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
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Unichem Labs gets USFDA approval for Guanfacine Tablets
expresspharma
March 05, 2021
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.
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Unichem Laboratories gets USFDA approval for Apremilast Tablets
expresspharma
February 20, 2021
Unichem Laboratories has received ANDA approval for its Apremilast Tablets, 10 mg, 20 mg and 30 mg from the United States Food and Drug Administration (USFDA) to market a generic version of Amgen’s Otezla (apremilast) Tablets, 10 mg, 20 mg, and 30 mg.
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Unichem gets USFDA approval for Zonisamide Capsules
expresspharma
January 28, 2021
They are indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.
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Unichem gets US FDA approval for Tolterodine Tartrate tablets
expresspharma
August 07, 2020
These tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
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Unichem, Lupin voluntarily recall hypertension medicines in the US
expresspharma
June 22, 2020
Unichem is recalling 1,90,992 bottles of Clonodine Hydrochloride tablets while Lupin is recalling 4,224 bottles of Lisinopril tablets.
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Unichem recalls 96,876 bottles of Bisoprolol Fumarate tabs
expressbpd
October 27, 2017
Unichem Laboratories is recalling 96,876 bottles of Bisoprolol Fumarate tablets used for the treatment of hypertension from the US market.
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Unichem gets EIR from US FDA for Goa plant
financialexpress
July 03, 2017
The receipt indicates successful closure of the inspection and queries raised during the audit
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Unichem gets EIR from US FDA for Goa plant
expressbpd
July 03, 2017
The receipt indicates successful closure of the inspection and queries raised during the audit
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Unichem Laboratories gets EIR for Ghaziabad formulation unit
expressbpd
June 08, 2017
The receipt indicates the successful closure of the inspection and the queries raised during the audit