Addressing US FDA challenges in Indian sterile drug manufacturing – Part 2
In this second part, Manish Bhatkar, Founder & CEO, RedLotus Pharmtech continues the discussion on FDA expectations, with…
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Browsing Tag
USFDA
What the new drug rules mean for quality control in Pharma: From lab to license
Dr Saurabh Arora, Managing Director, Auriga Research, explains how prioritising integrity, infrastructure, digital systems, and…
Alembic gains USFDA final approval for Amlodipine & Atorvastatin Tablets USP, 2.5 mg/10 mg, 2.5…
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Caduet Tablets, of Pharmacia and…
Indoco Remedies gains USFDA final approval for Allopurinol Tablets USP 200 mg
Allopurinol prevents or lowers high uric acid levels caused by cancer medicines or in patients with kidney stones
Lupin gains USFDA approval for Rivaroxaban Tablets USP, 10 mg, 15 mg, and 20 mg
Rivaroxaban Tablets are bioequivalent to Xarelto Tablets, 10 mg, 15 mg, and 20 mg, of Janssen Pharmaceuticals
Lupin launches Tolvaptan Tablets in the US
Lupin holds the exclusive first-to-file status for this product and will have 180-day generic drug exclusivity
Lupin gains USFDA nod for Raltegravir Tablets USP, 600 mg
Being the exclusive first-to-file, Lupin is eligible for 180-day generic exclusivity
FDA approves trial to advance treatment for Hereditary Spastic Paraplegia (HSP)
The trial will be conducted in the United States at Boston Children’s Hospital and will assess the safety, tolerability, and…
Strides Pharma receives USFDA approval for Celecoxib Capsules in multiple strengths
Approval from USFDA allows Strides Pharma to market Celecoxib Capsules 100 mg, 200 mg, and 400 mg in the United States
SPARC announces submission of IND application for SBO-154 to USFDA
SBO-154 set to enter global Phase 1 clinical trial for treatment of advanced solid tumours