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 […]
Mumbai-based chemicals firm, Omkar Speciality Chemicals, said it received a process patent from the Government of India for its process to manufacture artificial sweetener sodium saccharin. Under a process patent, exclusivity is granted for a particular manufacturing process, and not for the product itself. Others can produce the same product through a different process, modifying […]
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 […]
Mumbai-based pharmaceutical firm Glenmark Pharmaceuticals said it received approval from the Russian Health Ministry for the sales of Momate Rhino, also called Mometasone Furoate metered nasal spray, as an over-the-counter (OTC) drug. Over-the-counter drugs are medicines sold directly to a consumer without prescription from a healthcare professional, as opposed to prescription drugs, which may be […]
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 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 […]
Alembic Pharmaceuticals said it has received approval from the US Food & Drug Administration (USFDA) to sell an equivalent drug of Lumigan eye drops of Allergan. Bimatoprost Ophthalmic Solution 0.03% has an estimated US market size of $ 76 million. It is indicated for the reduction of elevated intraocular pressure in patients with open angle […]
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 […]
