Pipeline and approval signals
Search agency notices, approvals, recalls, and regulatory updates from global authorities.
1,100 of 1,100 tracked regulatory updates from 40 agencies and publishers, page 21 of 22.
M/s. Apex Healthcare Limited โ Carbamide Peroxide USP and 20 itemsCDSCO IndiaM/s. Asence Pharma Pvt. Ltd, โ Fluconazole EPCDSCO IndiaM/s. Alkaloids Bioactives Private Limited โ Colchicine BP/Ph.Eur./USP and 3 itemsCDSCO IndiaM/s. Aalidhra Pharmachem Pvt. Ltd. โ Bosentan Monohydrate IH and 8 itemsCDSCO IndiaM/s. Alivus Life Sciences Limited โ Aprepitant EP and 72 itemsCDSCO IndiaIndiscriminate use of painkillers (NSAIDs), antibiotics and associated risk of Chronic Kidney DiseaseCDSCO IndiaM/s. Reine Lifescience โ Pregabalin BP/EP and 5 itemsCDSCO IndiaM/s. Valencia Life Sciences โ Lidocaine BP/EP/USP and Lidocaine Hydrochloride BP/EP/USPCDSCO IndiaM/s Olon Active Pharmaceutical Ingredients India Private Limited, โ Rifampicin Ph.Eur/ BP and 13 itemsCDSCO IndiaM/s. Amoli Organics โ Solifenacin Succinate IH and 29 itemsCDSCO IndiaM/s. Hetero Drugs Limited (Unit-IX) โ Gabapentin USP/Ph.Eur. and 42 itemsCDSCO IndiaM/s. Herbert Brown Pharma. & Research Lab. โ Methyl Nicotinate Ph. Eur/BP and Benzyl Nicotinate DAรยCDSCO IndiaM/s. MSN Organics Private Limited โ Asenapine Maleate Iรย and 20 itemsCDSCO IndiaClarification on the submission of applications for grant of Permission to Import and Market New Drugs not approved anywhere in the world, wherein phase III Global Clinical Trials (GCT) are ongoing or completed with participation of Indian subjects under the New Drugs and Clinical Trials Rules, 2019CDSCO IndiaM/s. SUNMOON PHARMACEUTICALS PVT. LTD. โ Isoxsuprine Hydrochloride USP and 3 itemsCDSCO IndiaM/s. Dr. Reddy's Laboratories Limited. โ Abemaciclib IH and 37 itemsCDSCO IndiaM/s. Suleshvari Pharma Pvt Ltd โ Famotidine BP and 13 itemsCDSCO IndiaM/s. Nuray Chemicals Private Limited, โ Ketoconazole Ph.Eur. and 58 itemsCDSCO IndiaM/s. Lokhith Healthcare Pvt. Ltd. โ Guaifenesin USPCDSCO IndiaM/s. Anuh Pharma Limited (Public Limited), โ Gliclazide Ph.Eur and 14 itemsCDSCO IndiaM/s. Unimax Chemicals Pvt. Ltd. (Private Limited) โ Erythromycin Base BP/USP/EP and 2 itemsCDSCO IndiaVigilance on imported cosmetics products sold in the domestic market without valid lmport Registration certificateCDSCO IndiaClarification regarding submission of applications under Rule 4 of the Drugs and Cosmetics (Compounding of Offences) Rules, 2025.CDSCO IndiaM/s. Nira Life Sciences Pvt. Ltd. โ Clonixin Lysinate Iรย and 4 itemsCDSCO IndiaM/s. Endoc Biotech Private Limited โ Mupirocin IP/BP/EP/USPCDSCO IndiaM/s. Shodhana Laboratories Private Limited, โ Etofenamate Ph.Eur. and 16 itemsCDSCO IndiaM/s. Lewens Labs Pvt. Ltd. โ Levodropropizine EP and 3 itemsCDSCO IndiaM/s. Ravi Biolife Private Limited, โ Methotrexate Disodium IH and 8 itemsCDSCO IndiaM/s. Honour Lab Limited, โ Tedizolid Phosphate IHCDSCO IndiaGuidance document on Medical Device Software under MDR-2017CDSCO IndiaM/s. Megafine Pharma (P) Ltd. โ Donepezil Hydrochloride Monohydrate Ph. Eur. and 4 itemsCDSCO IndiaM/s. Hetero Labs Limited, Unit-IX โ Abacavir Sulphate USP and 12 itemsCDSCO IndiaM/s. Elixir Pharma Chem Private Limited, โ Glibenclamide BP and 2 itemsCDSCO IndiaM/s. Kadamb Pharmachem, โ Valproic Acid BP/IP and 2 itemsCDSCO IndiaM/s. Titan Pharmaplus Pvt Ltd. โ Carbocisteine Ph. Eur. and Eltrombopag Olamine IHCDSCO IndiaM/s. Atul Bioscience Ltd. โ Fluconazole BP/รยร and 14 itemsCDSCO IndiaM/s. Kevy's Generics Private Limited โ Escitalopram Oxalate IP/EP/USP and Carvedilol IP/EP/USPCDSCO IndiaM/s. Haleos Labs Limited โ Cimetidine USP and 11 itemsCDSCO IndiaM/s. Lifecare Laboratories Private Limited โ Biperiden Hydrochloride Ph.EurCDSCO IndiaM/s. Andhra Organics Limited โ Sulfadiazine BP/ Ph.Eur /USP and 3 itemsCDSCO IndiaInviting comments on consideration of the proposal regarding Issue of use of brand name extensions by the pharmaceutical firmsCDSCO IndiaM/s. Bal Pharma Ltd, โ Ebastine BP/EP and Gliclazide BP/EPCDSCO IndiaM/s. Melody Healthcare Pvt. Ltd. โ Perindopril Arginine IH and 20 itemsCDSCO IndiaM/s. Neuland Laboratories Ltd, Unit-I, โ Rotigotine Ph.Eur and 27 itemsCDSCO IndiaM/s. Optimus Drugs Private Limited. โ Apixaban IHS and 19 itemsCDSCO IndiaM/s Zentiva Private Limited โ Trimecaine Hydrochloride IH and 9 itemsCDSCO IndiaList of new drugs approved in the year 2001CDSCO Indiam/s. Alivus Life Sciences Limited โ Olopatadine Hydrochloride USP and 56 itemsCDSCO IndiaM/s. Valens Molecules Private Limited โ Sulfamethizole BP/Ph.Eur. and Sulfasalazine BP/USP/Ph.EurCDSCO IndiaSale of In-Vitro Fertilization media, reagents and related consumables used in Assisted Reproductive Technology proceduresCDSCO India