Direct answer What Montek-LC actually is Montek-LC is a prescription-only tablet from Sun Pharmaceutical Industries containing montelukast 10 mg and levocetirizine 5 mg. It is taken once daily in the evening for allergic rhinitis, chronic urticaria and as add-on therapy…
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…
Short answer · updated 22 Sep 2026 What a pharma plant acquisition checklist must cover A pharma plant acquisition checklist tests whether a plant can legally keep running under new ownership and reliably make compliant product. In India, clear four…
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: All 46 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…
In force since 1 April 2026 The 2026 DPCO ceiling prices, in one paragraph NPPA’s office memorandum of 25 March 2026 fixed the annual Wholesale Price Index movement at +0.64956% for calendar year 2025 over 2024, using data from the…
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,…
Short answer. Under Ph. Eur. 2.9.5 a powder for parenteral administration with an average mass above 40 mg is tested by weighing 20 containers: not more than 2 may deviate from the average by more than 10%, and none by more…
Laamox CV dry syrup is an oral antibiotic suspension containing amoxicillin and potassium clavulanate, used mainly in children to treat bacterial infections such as ear, sinus, throat, chest, skin and urinary‑tract infections[1–3] It combines a penicillin‑class antibiotic with a beta‑lactamase…