Tag Archives: usfda

Zydus Cadila has received the final approval from the United States Food and Drug Administration (USFDA) to market Nystatin and Triamcinolone Acetonide Ointment USP, (US RLD -Mycolog-II Ointment), 100,000 units/gram and 1 mg/gram. It will be manufactured at the group’s Topical manufacturing facility at Ahmedabad. It is used to treat …

Lupin has received the Establishment Inspection report (EIR) post the completion of a Pre-Approval Inspection (PAI) for its Phenytoin Sodium Extended Release 100 mg capsules, carried out by The United States Food and Drug Administration (USFDA) at its Nagpur facility in Maharashtra. The inspection conducted in September 2018 concluded without …

United States Food and Drug Administration (USFDA) has conducted a pre-approval inspection of Biocon’s new Oral Solid Dosage Forms manufacturing facility at Bengaluru from November 05 to 09. The audit concluded without any observations and no Form 483 was issued. Biocon is India’s largest and Asia’s leading Biotechnology Company with …

Cipla has received final approval for its Abbreviated New Drug Application (ANDA) for Valganciclovir Tablets 450mg from the United States Food and Drug Administration (USFDA). The company’s Valganciclovir Tablets 450mg is AB-rated generic therapeutic equivalent version of Roche’s Valcyte. It is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated …

Solara Active Pharma Sciences has completed USFDA inspection at its multi-product API facility in Mangalore. As part of GMP compliance audit, the company has received Establishment Inspection Report (EIR) from USFDA, thereby confirming the closure of the inspection in July 2018. Solara Active Pharma Sciences is a young, dynamic, entrepreneurial …

JB Chemicals & Pharmaceuticals (JBCPL) has received an approval from the US Food and Drug Administration (USFDA) for Abbreviated New Drug Application (ANDA) for Midodrine Hydrochloride Tablets USP 2.5 mg, 5 mg and 10 mg. (for treatment of orthostatic hypotension). The company plans to commercialize this product in Q1 of …

Zydus Cadila has launched Vardenafil Hydrochloride Tablets (US RLD – LEVITRA Tablets), 2.5 mg, 5 mg, 10 mg and 20 mg in the US market upon receiving the final approval from the US Food and Drug Administration (USFDA). Manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad, the medication …

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) for Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil), a generic version of Derma-Smoothe/FS Topical Oil, 0.01% (Scalp Oil), of Hill Dermaceuticals, Inc. According to IQVIA sales data for the 12 month …

The US Food and Drug Administration (USFDA) has completed an inspection at Alembic Pharmaceuticals’ general oral solid formulation facility at Panelav, Gujarat, India. The facility was inspected from October 22, 2018 to October 26, 2018. At the end of the inspection, the US FDA issued a Form 483 with four …

Zydus Cadila has received the final approval from the US Food and Drug Administration (USFDA) to market Clobazam Tablets, (US RLD-ONFI Tablet), 10 mg and 20 mg. It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. Clobazam is used in combination with other medications to treat …

Lupin has received approval for its Triamcinolone Acetonide Ointment USP, 0.1% from the United States Food and Drug Administration (FDA) to market a generic version of Mylan Pharmaceuticals, Inc.’s (Mylan) Triamcinolone Acetonide Ointment, 0.1%. Lupin’s Triamcinolone Acetonide Ointment USP, 0.1% is the generic version of Mylan’s Triamcinolone Acetonide Ointment, 0.1%. …

Alembic Pharmaceuticals is currently trading at Rs. 616.05, up by 7.95 points or 1.31% from its previous closing of Rs. 608.10 on the BSE. The scrip opened at Rs. 619.35 and has touched a high and low of Rs. 621.00 and Rs. 614.00 respectively. So far 992 shares were traded …

Alembic Pharmaceuticals and Orbicular Pharmaceutical Technologies’ Joint Venture (JV) Company — Aleor Dermaceuticals has successfully cleared its first United States Food and Drugs Administration (USFDA) inspection of its new formulation manufacturing facility located at Karakhadi in the state of Gujarat; without any observations. The scheduled inspection was carried out between …

Strides Pharma Science’s step‐down wholly owned subsidiary, Strides Pharma Global Pte, has received approval for Gabapentin Capsules USP, 100 mg, 300 mg, and 400 mg from the United States Food and Drug Administration (USFDA). Gabapentin Capsules is a generic version of Neurontin Capsules of Pfizer. The product received approval in …

US Food and Drug Administration (USFDA) has issued four minor observations to JB Chemicals & Pharmaceuticals’ solid oral manufacturing facility at Panoli, Gujarat. The company proposes to address these observations within next 15 days. These observations will not have any impact on the current business and will facilitate ANDA of …

Zydus Cadila has received tentative approval from the US Food and Drug Administration (USFDA) to market Colchicine Tablets USP (US RLD – ColcyrsTM), 0.6 mg. It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. This medication is used to prevent or treat attacks of gout (also …

Zydus Cadila has received the final approval from the US Food and Drug Administration (USFDA) to market Clobetasol Propionate Cream, (USRLD Temovate Cream), 0.05%. It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. Clobetasol Propionate is a topical (for the skin) steroid used to treat inflammation …

Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Alogliptin Tablets, 6.25 mg, 12.5 mg and 25mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), NESINA Tablets, 6.25 mg, 12.5 mg and …

Lupin has received tentative approval for its Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg and 120 mg from the United States Food and Drug Administration (USFDA) to market a generic version of Sunovion Pharmaceuticals Inc.’s (Sunovion) Latuda Tablets, 20 mg, 40 mg, 60 mg, 80 mg …

Glenmark Pharmaceuticals’ subsidiary — Glenmark Pharmaceuticals Inc, USA has been granted final approval by the United States Food and Drug Administration (USFDA) for Hydrocortisone Valerate Cream USP, 0.2%, a generic version of Westcort Cream, 0.2%, of Sun Pharmaceutical Industries Inc. According to IQVIA sales data for the 12-month period ending …