Formulation guide · India · Updated August 2026 Short answer: since 9 June 2026 there is no “best dry cough syrup you can buy” in India, because you can no longer buy one off the shelf. Notification G.S.R. 477(E) deleted…
Short answer · HPLC price in India There is no list price for a new pharma-grade HPLC in India — only quotes for a configuration Agilent, Waters, Shimadzu, Thermo Fisher and PerkinElmer do not publish Indian prices for their current…
MYQORZO (aficamten) represents a significant advancement in the management of obstructive hypertrophic cardiomyopathy (oHCM), a condition characterized by thickened heart muscle that obstructs blood flow out of the heart. Approved by the FDA in December 2025, it provides a targeted…
Short answer: what a pharma plant costs in India in 2026 The pharma manufacturing plant cost in India runs from roughly ₹5–15 crore for a small oral-solids unit, ₹50–80 crore for a mid-scale multi-formulation export-capable facility, and ₹170–355 crore for…
The short answer ALCOA is five data-integrity attributes — Attributable, Legible, Contemporaneous, Original, Accurate. ALCOA+ adds four more (Complete, Consistent, Enduring, Available) for nine. ALCOA++ adds a tenth, Traceable, and is the form the European Medicines Agency uses for clinical-trial…
On December 12, 2025, the U.S. Food and Drug Administration (FDA) approved Lerochol (lerodalcibep-liga), a novel third-generation proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor developed by LIB Therapeutics, Inc. Lerochol is approved as an adjunct to diet and exercise to…
HYRNUO® (sevabertinib), a reversible tyrosine kinase inhibitor targeting HER2 (ERBB2), received FDA approval on November 19, 2025, under the accelerated approval pathway for a molecularly defined population of lung cancer patients [Approval Letter, November 19, 2025, Reference ID: 5698585]. This approval…
This post provides a consolidated and structured overview of FDA novel drug approvals in 2025, covering pharmaceutical products that received first-time approval in the United States during the calendar year. Unlike the official listings published by the FDA, this page…
On November 25, 2025, the U.S. Food and Drug Administration (FDA) granted accelerated approval to VOYXACT (sibeprenlimab-szsi), a novel biologic therapy for adults with primary immunoglobulin A nephropathy (IgAN)[3]. Developed by Otsuka Pharmaceutical Company, Ltd., this approval marks a significant…
In pharmaceutical manufacturing, selecting a tablet compression machine that meets USFDA and EU GMP standards ensures consistent tablet quality, high throughput, and seamless regulatory compliance. These top five models—Fette Compacting FE55, Korsch AG XL 400 (4th Generation), GEA NexGen Press…