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Zydus Lifesciences
Drug firm Zydus Lifesciences is recalling over 55,000 bottles of generic medication in the US market due to failed impurities specifications. As per the latest enforcement report by the US Food and Drug Administration (USFDA), Zydus Pharmaceuticals (USA) Inc is recalling 21,936 (30 count) and 33,096 (100 count) bottles of Colchicine tablets, which are used to treat gout. The affected lot is manufactured by Ahmedabad-based Zydus Lifesciences and marketed in the US by New Jersey-based Zydus Pharmaceuticals (USA) Inc. USFDA said the company is recalling the product due to "failed impurities/ degradation specifications". An out-of-specification (OOS) result was observed during release testing of one lot for a related substance, i.e. Beta-lumicolchicine, it added. Zydus commenced the Class III recall on February 24 this year. As per the USFDA, a Class III recall is initiated in a "situation in which use of, or exposure to, a violative product is not likely to cause adverse health ...
Zydus Lifesciences Ltd on Friday said it has received final approval from the US health regulator for its generic doxepin hydrochloride capsules used in the treatment of depression and anxiety. The approval granted by the US Food and Drug Administration (USFDA) is for doxepin hydrochloride capsules of strength 150 mg, the company said in a regulatory filing. The drug will be manufactured at the group's formulation manufacturing facility in Moraiya, Ahmedabad, it added. Doxepin hydrochloride capsule is indicated to treat mental/mood problems such as depression and anxiety. It helps improve moods and feelings of well-being, relieves anxiety and tension, helps sleep better and increases the energy level, it added. The drug had annual sales of USD 2.11 million in the US, the company said citing IQVIA MAT January 2023 data.
Zydus Lifesciences on Tuesday said it has received approval from the US health regulator to market a generic medication to prevent and treat blood clots. The company has received approval from the US Food and Drug Administration (USFDA) to market Apixaban tablets in strengths of 2.5 and 5 mg, according to a regulatory filing. Apixaban blocks the activity of certain clotting substances in the blood. It is used to lower the risk of stroke or a blood clot in people with a heart rhythm disorder called atrial fibrillation. It is also used to reduce the risk of forming a blood clot in the legs and lungs of people who have just had hip or knee replacement surgery. The drug will be manufactured at the Zydus group's formulation manufacturing facility at Moraiya, Ahmedabad. As per IQVIA MAT December 2022 data, Apixaban tablets had annual sales of USD 18,876 million in the US.
Zydus Lifesciences on Monday said it has received approval from the US health regulator to market generic medicines in the American market. The company has received approval from the US Food and Drug Administration (USFDA) to market Gabapentin tablets which are indicated for the management of postherpetic neuralgia (PHN). As per IQVIA MAT data, the medication had annual sales of USD 90 million in the US. The company said it also has received approval from the US health regulator for diabetes drug Canagliflozin and Metformin Hydrochloride tablets. As per IQVIA MAT data, Canagliflozin and Metformin Hydrochloride tablets had annual sales of USD 49.4 million in the US. Shares of the company on Monday ended 1.36 per cent down at Rs 464.15 apiece on the BSE.
Zydus Lifesciences Ltd on Friday reported a 24.48 per cent rise in consolidated net profit at Rs 622.9 crore for the third quarter ended December 31, 2022. The company had posted a consolidated net profit of Rs 500.4 crore in the same period last fiscal, Zydus Lifesciences Ltd said in a regulatory filing. Consolidated total revenue from operations during the quarter under review stood at Rs 4,362.3 crore, as against Rs 3,639.8 crore in the year-ago period, it added. Total expenses in the third quarter were higher at Rs 3,620.7 crore, as compared to Rs 3,096.3 crore in the corresponding period last fiscal. In the third quarter, its business in India comprising formulations as well as consumer wellness registered revenues of Rs 1,643.6 crore, up 13 per cent, while the US formulations business registered revenues of Rs 1,925 crore, up 29 per cent from the year-ago period, the company said. Emerging markets formulations business registered revenues of Rs 307.8 crore, up 15 per cent an
Zydus Lifesciences on Friday said it has launched generic epilepsy treatment medication in the US market. Zydus Pharmaceuticals (USA) Inc, a unit of the company, has launched Topiramate extended-release capsules in the American market. The company had earlier received final approval from the US Food and Drug Administration (USFDA) to market the product in strengths of USP 25 mg, 50 mg, and 100 mg, Zydus Lifesciences said in a statement. Zydus is the first company to receive final approval and launch the medication in the above mentioned strengths, it added. Topiramate extended-release capsules are indicated for epilepsy: initial monotherapy in patients who are six years of age and older with partial onset or primary generalized tonic-clonic seizures. It is also indicated for prophylaxis of migraine in patients 12 years of age and older. As per IQVIA data, Topiramate extended-release capsule had annual sales of USD 488 million in the US.
Zydus Lifesciences Ltd on Friday said it has received final approval from the US health regulator to market its generic version of Triazolam tablets used on a short-term basis to treat insomnia. The approval granted by the US Food and Drug Administration (USFDA) is to market Triazolam tablets of strengths 0.125 mg and 0.25 mg, the company said in a regulatory filing. The medicine is used on a short-term basis to treat insomnia -- difficulty falling asleep or staying asleep. It works by slowing activity in the brain to allow sleep. It will be manufactured at the group's formulation manufacturing facility at Moraiya, Ahmedabad, the company said. Triazolam tablets had annual sales of USD 11.7 million in the US, the company said, citing IQVIA MAT September 2022 data.