Cadila Healthcare gets US FDA warning letter for Moraiya facility

Cadila Healthcare, one of India’s biggest pharmaceutical companies, said it has received a ‘warning letter’ from the US Food and Drug Administration relating to its Moraiya formulations facility in Gujarat. The Moraiya facility is the company’s largest plant that makes tablets and injectables and is estimated to contribute about 40-50% of its U.S. exports. Shares […]

Zydus Cadila’s manufacturing facilities in US receives 11 observations from FDA

Pharmaceutical manufacturer Zydus Cadila said that the United States Food and Drug Administration (USFDA) issued 11 observations after inspections at two of the manufacturing facilities of Nesher Pharmaceuticals, a subsidiary of Zydus’ US arm. Both the facilities are located at St Louis, United States. issuing of observations indicate that the inspectors did not find everything […]

Zydus Cadila gets USFDA nod for stomach infection drug

Pharmaceutical manufacturer Zydus Cadila said that it received final approval from the United States Food and Drug Administration (USFDA) for the sales of a generic equivalent of Nexium Delayed-Release capsules manufactured by Teva Pharmaceutical Industries. Esomeprazole, which belongs to a class of medicines called proton pump inhibitors, works by reducing the the amount of acid […]

Zydus Cadila gets USFDA approval for sales of hypertension drug

Pharmaceutical manufacturer Zydus Cadila said it received the final approval for sales of a generic equivalent of Pfizer’s Thalitone tablets. Chlorthalidone tablets are used for the treatment of high blood pressure or hypertension. It is also used to treat fluid retention or edema in people with congestive heart failure, cirrhosis of the liver or kidney […]

Zydus’ Ahmedabad plant gets 14 observations in USFDA inspection

Pharmaceutical manufacturer Zydus Cadila said that the United States Food and Drug Administration has issued 14 observations after an inspection at its manufacturing facility at Moraiya, Ahmedabad. Observations indicate that the inspectors did not find everything up to order, and want the company to make amendments to its procedures and process at the facility. Moraiya […]

Zydus Cadila gets USFDA nod for generic Syprine, Tracleer drugs

Pharmaceutical manufacturer Zydus Cadila said it received approval from the United States Food and Drug Administration for the sales of a generic version of Valeant Pharmaceuticals’ Syprine capsules and a generic version of Actelion Pharmaceuticals’ Tracleer tablets. Trientine Hydrochloride capsules are chelating agents used for the treatment of Wilson’s disease, a genetic metabolic defect that […]

Zydus Cadila Gets USFDA Nod For Sales Of Rheumatoid Arthritis Drugs

Pharmaceutical manufacturer Zydus Cadila said it received final approval from the United States Food and Drug Administration for sales of a generic version of Aventis Pharma’s Arava tablets. Leflunomide tablets, belonging to a class of medications called disease modifying anti-rheumatic drugs, is used of the treatment of rheumatoid arthritis. Zydus said that its tablets will […]

Zydus Cadila announces Phase-III trials of anemia drug Desidustat

Pharmaceutical manufacturer Zydus Cadila announced phase-III trials of the Desidustat, an investigational new drug and a Hypoxia-Inducible Factor (HIF) Prolyl Hydroxylase (PH) enzyme inhibitor used for the treatment of anemia and chronic kidney disease. HIF-PH inhibitors are a new class of agents for the treatment of anemia in chronic kidney disease patients. Chronic Kidney Disease […]

Zydus Cadila receives tentative USFDA nod for generic Vimpat tablets

Pharmaceutical manufacturer Zydus Cadila said that it received tentative approval from the US Food and Drug Administration for sales of a generic equivalent of UCB Inc’s Vimpat tablets. A tentative approval means that the company has to wait for all patent and other protections to expire before starting the sale of the drug. Lacosamide is […]

Zydus Cadila receives tentative USFDA nod for overactive bladder drug

Pharmaceutical manufacturer Zydus Cadila said that it has received tentative approval from the US Food and Drug Administration for sales of mirabegron extended-release tablets. A tentative approval means that the company has to wait for all patent and other protections to expire before starting the sale of the drug. The tablets, currently sold under the […]

Zydus Cadila receives US nod for generic version of Gilead Sciences’ Letairis

Pharmaceutical manufacturer Zydus Cadila said that it has received approval from the United States Food and Drug Administration for the sales of a generic equivalent of Gilead Sciences’ hypertension drug Letairis. Ambrisentan tablets had sales of $943 million in the US market in 2018, marking it among the bigger drugs in the market. Ambrisentan tablets […]

Lupin, Unichem, Alembic & Zydus okayed to sell generic Cialis in US

Indian pharmaceutical manufacturers Lupin, Unichem Laboratories and Alembic Pharmaceuticals said that they has received approval from the United States Food and Drug Administration to sell generic versions of Eli Lilly’s Cialis erectile dysfunction tablets, while rival Zydus Cadila said it has already begun selling the tablets on day 1. The patent for Cialis, owned by […]

Zydus Cadila gets USFDA approval for schizophrenia drug

Pharmaceutical manufacturer Zydus Cadila said it received final approval from the United States Food and Drug Administration for sales of a generic version of Sunovion Pharmaceuticals’ Latuda tablets. Lurasidone tablets are used to treat certain conditions associated with bipolar disorder such as schizophrenia and depression. It also helps to decrease hallucinations. The drug will be […]

Zydus Cadila gets USFDA nod for generic Zovirax ointment for herpes

Pharmaceutical manufacturer Zydus Cadila said that it received final approval from the United States Food and Drug Administration for the sale of a generic version of Valeant’s Zovirax ointment. Acyclovir, belonging to a class of medications called antivirals, is used to treat cold sores or fever blisters caused by herpes viruses. The ointment will be […]

Zydus Cadila gets USFDA nod for potassium chloride tablets

Pharmaceutical manufacturer Zydus Cadila said it received final approval from the US Food and Drug Administration for the sales of Potassium Chloride extended-release tablets for the treatment of various diseases such as prolonged diarrhoea and vomiting, hormone problems such as hyperaldosteronism and diuresis. The tablet, sold under the brand names Klor-Con, K-Dur and Micro-K, is […]

Zydus confirms Heinz India buy for Rs 4,595 cr; gets Complan, Glucon D

Zydus Wellness, the consumer healthcare arm of Zydus Cadila, said it has agreed to acquire Heinz India Private Ltd, the Indian unit of global FMCG major Kraft Heinz. The transaction, which will be carried out in association with Cadila Healthcare Ltd, values Heinz India at Rs 4595 cr, the company said. Heinz India’s business comprises the brands Complan, Glucon D, […]

Zydus Cadila gets USFDA approval for cholesterol, psychosis drugs

Zydus Cadila said it received the final approval from the USFDA to market cholesterol-lowering Gemfibrozil and antipsychotic Aripiprazole in the US. Gemfibrozil Tablets are used together with diet to treat very high cholesterol and triglyceride levels in people with pancreatitis. It is also used to lower the risk of stroke, heart attack or other heart […]