Schedule H drugs are prescription medicines regulated under the Drugs and Cosmetics Rules, 1945, and they are sold only on the prescription of a Registered Medical Practitioner. For pharmaceutical manufacturers, marketers, distributors, pharmacies, and compliance teams, understanding Schedule H rules…
Liquid filling machine validation parameters are one of the most critical activities in pharmaceutical manufacturing because it directly determines the correct dose, sterility (for injectables), and consistency of every unit released to patients. Inadequate validation of liquid filling machine parameters…
Alu Alu packing (cold-form foil blister) is a high‑barrier blister format where both forming web and lidding are aluminium‑based films, typically OPA/Al/PVC laminate plus aluminium lidding foil. It provides near‑absolute protection against moisture, oxygen and light, making it ideal for…
A USFDA Warning Letter (WL) is the single most serious regulatory escalation a USFDA-regulated company can receive, confirming significant violations of the Federal Food, Drug, and Cosmetic (FD&C) Act, most often related to Current Good Manufacturing Practice (CGMP). Unlike a…
Granulation and drying are core unit operations in solid oral dosage manufacturing, directly impacting flowability, compressibility, content uniformity, and stability of tablets and capsules. Equipment selection at these stages is a major determinant of batch robustness, cycle time, and regulatory…
Acquiring an existing pharmaceutical manufacturing facility can accelerate market entry, add capacity, and diversify dosage forms, but it also imports the seller’s technical and compliance legacy. Robust current good manufacturing practice (cGMP) expectations from agencies such as the FDA, EMA,…
For an Indian formulation plant, “USFDA approval roadmap” essentially means that both your facility and your products meet United States Food and Drug Administration requirements for quality, safety, and compliance with current Good Manufacturing Practice (cGMP) under 21 CFR Parts…
This page provides a consolidated and continuously updated overview of FDA novel drug approvals in 2026, covering pharmaceutical products that receive first-time approval in the United States during the calendar year. Unlike the official FDA listing, which presents approvals in…
The National Pharmaceutical Pricing Authority (NPPA) has revised ceiling prices of scheduled formulations for 2026 based on an annual Wholesale Price Index (WPI) increase of 0.64956% for calendar year 2025 over 2024, effective from 1 April 2026. This post provides…
Overview Wegovy (semaglutide) is a long‑acting GLP‑1 receptor agonist available as a once‑weekly subcutaneous injection and a once‑daily high‑dose oral tablet. It is approved to reduce major adverse cardiovascular events in adults with established cardiovascular disease and obesity or overweight,…