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 […]
Pharmaceutical major Cipla and its subsidiary Cipla USA announced the phased launch of a generic therapeutic equivalent version of Sensipar, a branded drug manufactured by Amgen Inc. The launch, however, is a subject of ongoing litigation, Cipla said in a regulatory filing. Amgen’s Sensipar generated US sales of $1.43 billion in 2018. Cinacalcet hydrochloride tablets […]
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 […]
Ahmedabad-based Torrent Pharmaceuticals said its manufacturing facility at Indrad in Gujarat was subject to certain ‘procedural observations’ by the United States Food and Drug Administration following a routine inspection. The pharma company did not quantify how many observations were made by the US health regulator. Procedural observations are referred to as deficiencies in standard operating […]
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 […]
Alembic Pharmaceuticals said it received approvals from the United States Food and Drug Administration (USFDA) for sales of a therapeutic equivalent of French pharma major Sanofi Aventis’ Aubagio tablets and for a therapeutic equivalent of Novartis Pharmaceuticals Corporation’s Tobrex Ophthalmic Solution. Teriflunomide pills are used to reduce flare-ups in people with relapsing multiple sclerosis (MS). […]
Pharmaceutical manufacturer Granules India Ltd said that it has received approval from the United States Food and Drug Administration to sell a bioequivalent version of Johnson & Johnson’s Tylenol tablets. Acetaminophen Extended Release tablets, also known as Paracetamol, are used primarily for temporary pain management, including arthritis relief. It will be sold in doses of […]
Pharmaceutical major Lupin said that it has launched a generic equivalent of AbbVie Inc’s AndroGel, a a day after it received approval for its sales from the United States Food and Drug Administration (USFDA). Testosterone Gel is used for hormone replacement in men who are not able to produce enough testosterone. The medication is absorbed […]
Pharmaceutical major Lupin said that it has received approval from the United States Food and Drug Administration for the sales of a generic equivalent of AbbVie Inc’s AndroGel. Testosterone Gel is used for hormone replacement in men who are not able to produce enough testosterone. The medication is absorbed through the skin, enters the bloodstream, […]
Pharmaceutical major Lupin said that it launched a generic equivalent of Alvogen Group Holdings’ psychiatric drug Fluoxetine. Fluoxetine tablets sold in 60 mg dose had annual sales of $41 million in the US market as of February 2019. Fluoxetine is also sold under the brand name Prozac as a treatment for depression and other mental […]
Indian pharmaceutical manufacturer Caplin Point Laboratories said that its wholly-owned subsidiary Caplin Sterlites Ltd signed a licence and supply agreement with US healthcare firm Baxter International for sales of five generic injectable drugs. Under the agreement, Caplin will be supplying its products to Baxter for sales. “All these ANDAs [generic drugs] have been developed in-house, […]
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 […]
Pharma major Lupin said that the inspection of the US Food and Drug Administration (USFDA) at its bioresearch facility in Pune has concluded without any observation. Conclusion of an inspection without any observation indicates that the facility was found to be up to the standards expected by the FDA. This is also the fifth time […]
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 […]
Pharma major Lupin said that the United States Food and Drug Administration has given it an Establishment Inspection Report (EIR) for its Pithampur facility, which was slapped with five observations in an inspection in October. The receipt of an EIR is considered good news as it means that the company can now use the facility […]
Pharmaceutical Strides Pharma Science Ltd said wholly owned subsidiary Vensun Pharmaceuticals and partner Pharmaceutics International received approval from the United States Food and Drug Administration to launch a generic equivalent of Merck’s potassium chloride extended-release tablets. The drug will be launched in the doses of 750 mg, 1,125 mg and 1,500 mg. Strides Pharma already […]
Pharmaceutical major Lupin said that it has launched the generic equivalent of Eli Lilly’s Cialis erectile dysfunction tablets. Lupin had received the approval from the United States Food and Drug Administration to sell the tablets along with its rivals Zydus Cadila, Unichem Laboratories and Alembic Pharmaceuticals on March 27. Tadalafil tablets are used to treat […]
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 […]
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 […]
Pharmaceutical major Strides Pharma Science Ltd said it received approval from the United States Food and Administration for its greenfield oral medication facility in Singapore, giving a boost to the company’s efforts to bid for US government contracts. The new unit will help the company supply its products to US government agencies as Singapore is […]
