The USFDA has completed an inspection of the facility of Granules Pharmaceuticals, Inc., a wholly-owned foreign subsidiary of Granules India located in Chantilly, Virginia, the USA on July 22, 2022 with six observations. Granules Pharmaceuticals, Inc. will respond to these observations within the stipulated time period. Granules India is manufacturer and supplier of pharmaceutical products. … Read more
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 fungal skin infections. This product … Read more
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 any observations. Lupin’s Nagpur facility … Read more
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 a strategic focus on biopharmaceuticals … Read more
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 for use in the treatment … Read more
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 and customer oriented API manufacturer. … Read more
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 next financial year and is … Read more
