Staphyt’s Post

On 19 May, you may have noticed in our PPP & PNP Regulatory overview that the list of unacceptable co-formulants was updated on 1 April; and in a previous breaking news, that the Regulation (EU) 2026/1120 had been implemented on 26 May. Last 26 June, ANSES released a note on how to implement the new Regulation in France. For authorisation requests submitted before 16/06/2026, and currently under instruction, requests for non-significant changes in composition must be submitted as soon as possible and no later than 16/12/2026. And more urgently, no later than 31/07/2026, holders of plant protection products, adjuvants, and mixed products containing one or more co-formulants newly added to Annex III are invited to declare them to ANSES via email. Our team in Staphyt will be happy to guide you and support you in the preparation of your dossiers. As a reminder, these new forbidden co-formulants are: Acetaldehyde  Propylene oxide  Cumene Dodecamethylcyclohexasiloxane; (D6)  Decamethylcyclopentasiloxane; (D5)  Octamethylcyclotetrasiloxane; (D4)  2-(2'-hydroxy-3'-tert-buty-5'- methylphenyl)-5-chlorobenzotriazole Distillates (petroleum) solvent-dewaxed light paraffinic with a content of ≥ 3,0 % DMSO-extract (measured by IP 346)  3,5,7-Triaza-1-azoniatricyclo[3.3.1.1 3,7] decane,1-(3-chloro-2-propen-1-yl)-, chloride  Phosphinic acid, bis(perfluoroC6-12-alkyl) derivatives 1,4-dioxane  2-(4-tert-butylbenzyl)propionaldehyde  Would you be struggling to find suitable alternatives to these compounds, we can also support this aspect thanks to Staphyt collaboration with Stepan, Advanced Formulation Service. We are here to help ! #Staphyt #PPP #coformulants #ANSES Romain Galy Geoffroy Moulin Elena Campagnoli Asha Hoque Evelyne Güsken

Make sure you have your plans ready to manage these withdrawals. For all alternatives search, a joint work can be operated with Stepan Agricultural Solutions Advanced Formulation Service Laure Canal

Already marketing a tetracycline product internationally or planning a new registration in the US or another regulated market? 🌍 For established APIs such as Tetracycline Hydrochloride, compliance requirements continue to evolve. Nitrosamine control, comprehensive regulatory documentation and long-term supply reliability are now central to product continuity and future submissions. At Suanfarma, we manufacture Tetracycline Hydrochloride API in Europe, in compliance with USP and Ph. Eur. requirements, with robust nitrosamine control, a granted CEP, an active US DMF and a reliable long-term supply framework. Read the full article on our blog: https://lnkd.in/g4cm82Np 🔬 For further information about Tetracycline Hydrochloride API, please contact Emanuele Butturi. #TetracyclineHydrochloride #API #EuropeanManufacturing #RegulatoryAffairs #PharmaceuticalIndustry

🔬 Promethazine hydrochloride ✨ Explore how you can assemble promethazine hydrochloride using three straightforward, low‑cost operations that fit any standard lab. These steps streamline production, cutting reagents and time while delivering a pharmaceutically relevant antihistamine at a fraction of conventional costs. ✓ 🧪 Dissolve phenothiazine (10 g) and potassium carbonate (2 equiv) in ethanol, stir at room temperature. ✓ 🔥 Add 2‑chloro‑N,N‑dimethylethylamine (1.2 equiv), reflux 4 hours, allowing alkylation to form promethazine base. ✓ ❄️ Cool, acidify with hydrochloric acid, filter precipitated promethazine·HCl, wash, and recrystallize from ethanol. 🟢 What challenges have you faced when scaling simple alkylations for active pharmaceutical ingredients? #MedicinalChemistry #Promethazine #SyntheticEfficiency #CostEffective #PharmaInnovation

🔬 Promethazine hydrochloride ✨ Explore how you can assemble promethazine hydrochloride using three straightforward, low‑cost operations that fit any standard lab. These steps streamline production, cutting reagents and time while delivering a pharmaceutically relevant antihistamine at a fraction of conventional costs. ✓ 🧪 Dissolve phenothiazine (10 g) and potassium carbonate (2 equiv) in ethanol, stir at room temperature. ✓ 🔥 Add 2‑chloro‑N,N‑dimethylethylamine (1.2 equiv), reflux 4 hours, allowing alkylation to form promethazine base. ✓ ❄️ Cool, acidify with hydrochloric acid, filter precipitated promethazine·HCl, wash, and recrystallize from ethanol. 🟢 What challenges have you faced when scaling simple alkylations for active pharmaceutical ingredients? #MedicinalChemistry #Promethazine #SyntheticEfficiency #CostEffective #PharmaInnovation

🔬 Promethazine hydrochloride ✨ Explore how you can assemble promethazine hydrochloride using three straightforward, low‑cost operations that fit any standard lab. These steps streamline production, cutting reagents and time while delivering a pharmaceutically relevant antihistamine at a fraction of conventional costs. ✓ 🧪 Dissolve phenothiazine (10 g) and potassium carbonate (2 equiv) in ethanol, stir at room temperature. ✓ 🔥 Add 2‑chloro‑N,N‑dimethylethylamine (1.2 equiv), reflux 4 hours, allowing alkylation to form promethazine base. ✓ ❄️ Cool, acidify with hydrochloric acid, filter precipitated promethazine·HCl, wash, and recrystallize from ethanol. 🟢 What challenges have you faced when scaling simple alkylations for active pharmaceutical ingredients? #MedicinalChemistry #Promethazine #SyntheticEfficiency #CostEffective #PharmaInnovation

7 TC molecules. One ZLD-compliant plant. Pymetrozine, Pretilachlor, Paclobutrazol, Pyriproxyfen, Pyroxasulfone, Metribuzin, Dinotefuran — plus formulation capability and toll manufacturing on request. Built for formulators who need supply reliability, not just a price sheet. #TechnicalGradePesticides #Agrochemicals #B2B #SafeAgrochemicals

Polymeric Ferric Sulfate (PFS) in Pharmaceutical Wastewater Treatment | High-Efficiency Phosphorus & COD Removal Solution 💧 Pharmaceutical wastewater contains high levels of organic pollutants, antibiotic residues, heavy metals, and phosphates, making treatment highly challenging. Aierfuke Chemical’s Polymeric Ferric Sulfate (PFS) delivers a stable and efficient solution for complex wastewater treatment. ⚗️ In phosphorus removal, PFS reacts with phosphate ions (PO₄³⁻) to form insoluble ferric phosphate precipitates, enabling rapid and effective dephosphorization. Meanwhile, hydrolysis products such as Fe(OH)⁺ enhance coagulation and adsorption, significantly reducing COD and capturing organic contaminants and heavy metals. 🌍 With advantages such as wide pH adaptability, fast-settling dense flocs, high treatment efficiency, and low operating cost, PFS is widely used in pharmaceutical, textile, and electroplating wastewater treatment applications. 🔗 Learn more about Aierfuke Chemical water treatment solutions: https://lnkd.in/gFYRxQBc #WastewaterTreatment #IndustrialWastewater #Coagulant #Flocculant #PFS #PolymericFerricSulfate #IndustrialWaterTreatment #AierfukeChemical

Water based manufacturing isn't just cleaner. It's a competitive advantage. At Farmson, our Paracetamol API is produced entirely through a water-based process, with zero organic solvents. That means a lower environmental footprint, safer conditions for our people and communities, and consistent, reliable quality batch after batch. Combined with our position as a global leader in Paracetamol and Acetaminophen production, indigenous raw material sourcing with no dependency on China, a dedicated facility carrying all major global accreditations, and a complete value proposition for drug substance, we help pharma partners build supply chains they can actually count on. Sustainable chemistry and supply security, in the same package. www.farmson.com #Paracetamol #Acetaminophen #API #PharmaManufacturing #GreenChemistry #SupplyChainResilience #Sustainability #PharmaceuticalIndustry #Farmson

Discover how Neusilin® S2 helps overcome Pitavastatin formulation challenges through optimal pH control, moisture protection, and reduced lactone formation.   Explore Fuji Chemical Industries’ latest technical newsletter for practical stabilization insights and comparative data. https://lnkd.in/dvpsHMU7 #Neusilin #Pitavastatin #PharmaceuticalFormulation #DrugStability #Excipients #FujiChemicalIndustries