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Tag Archives: usfda

Lupin’s Nagpur facility receives EIR from USFDA

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 ... Read More »

USFDA conducts inspection at Biocon’s Bengaluru facility

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 ... Read More »

Cipla gets approval from USFDA for Valganciclovir Tablets

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 ... Read More »

Solara Active gets EIR from USFDA for Mangalore facility

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 ... Read More »

JB Chemicals gets USFDA’s nod for Midodrine Hydrochloride Tablets

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 ... Read More »

Zydus Cadila gets final approval from USFDA for Clobazam Tablets

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 ... Read More »

Lupin receives USFDA’s approval for generic Triamcinolone Acetonide Ointment

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%. ... Read More »

Alembic Pharmaceuticals’ JV clears first USFDA inspection at its Gujarat facility

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 ... Read More »

Strides’ arm receives USFDA’s approval for Gabapentin Capsules

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 ... Read More »

USFDA issues four minor observations to JB Chemicals’ Gujarat facility

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 ... Read More »

Zydus Cadila receives approval from USFDA for Colchicine Tablets

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 ... Read More »