Fluticasone API Supplier India | 2 Grades | Bulk Export

Aarise Pharmaceuticals supplies fluticasone and fluticasone propionate as bulk corticosteroid APIs from India.

Available Fluticasone Grades

Choosing the Right Grade

Fluticasone propionate is a trifluorinated corticosteroid with a carbothioate ester at position 17. The extensive fluorination gives very high topical potency combined with rapid hepatic inactivation, which is the property that makes it suitable for inhaled delivery.

Quality Documentation — What to Request

Fluticasone propionate for inhalation requires tightly controlled aerodynamic particle size, typically micronised to a defined distribution. State the delivery route at enquiry, as material suitable for a topical cream is not interchangeable with inhalation grade. Request particle size distribution, assay by HPLC, related substances and residual solvents.

Import, Licensing & Logistics

Fluticasone APIs are not controlled substances. Standard pharmaceutical import licensing applies. Inhalation-grade material may attract additional documentation requirements at customs.

Inhalation Grade & Fluorination

Fluticasone propionate carries three fluorine substitutions and a carbothioate ester at position 17, which together give very high topical potency with rapid hepatic inactivation. For inhaled products the controlling parameter is aerodynamic particle size distribution measured by cascade impaction, not laser diffraction, and the two methods do not give comparable numbers. Confirm which method the supplied data uses before accepting a certificate.

Stability, Storage & Retest

Corticosteroids are photosensitive to varying degrees and several oxidise at the 11-hydroxyl or 21-hydroxyl positions on exposure to air and light. Store in the original sealed container protected from light. Soluble salt forms such as sodium phosphate and sodium succinate are hygroscopic and degrade on moisture uptake, so water content by Karl Fischer should be checked on receipt rather than relied on from the certificate if the consignment has been in transit through humid conditions.

Export Process & Lead Time

Corticosteroid APIs are not scheduled as controlled substances in most markets, which makes the export process considerably simpler than for anabolic compounds. A country of origin certificate and commercial invoice are usually sufficient. Several destinations, including a number of EU member states and Brazil, additionally require a manufacturer GMP certificate or a Certificate of Pharmaceutical Product at customs clearance, so confirm your national requirement before despatch.

Incoming Goods Inspection

Incoming checks should cover appearance, identification by IR against a reference standard, assay, and water content for the soluble salts. For material destined for topical or inhaled preparations, particle size distribution should be verified on receipt rather than accepted from the certificate, because micronised grades can agglomerate in transit and the finished product will not perform as expected.

Ordering Fluticasone API

Packaging runs from 250 g sealed aluminium bags to 5 kg drums, with larger commercial quantities quoted on request. Specify the grade, quantity and destination at enquiry so the quotation reflects the correct MOQ and documentation set. Mixed consignments across grades in this range ship as a single shipment.