Modified-release dosage forms / Compendial nomenclature Prolonged Release vs Sustained Release: What the Pharmacopoeias Actually Say Nearly every article on this topic invents a technical difference between the two terms. No pharmacopoeia and no regulator defines one. Here is what…
Montek-LC Tablet combines Montelukast 10 mg (a leukotriene receptor antagonist) and Levocetirizine 5 mg (a second-generation antihistamine). It is prescribed for allergic rhinitis, chronic urticaria, and asthma maintenance in adults and children over 12. One tablet is taken orally once…
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…
Live regulatory tracker · CDER novel approvals FDA New Drug List 2026: Novel Drug Approvals and Key Insights Every new molecular entity and new therapeutic biologic cleared by FDA’s Center for Drug Evaluation and Research in 2026, with sponsor, modality,…
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…