Hydrocortisone API Supplier India | 3 Grades | Bulk Export

Aarise Pharmaceuticals supplies hydrocortisone, hydrocortisone acetate and hydrocortisone sodium succinate as bulk corticosteroid APIs from India.

Available Hydrocortisone Grades

Choosing the Right Grade

Hydrocortisone is cortisol, the reference glucocorticoid against which others are compared. The acetate ester is poorly soluble and is selected for topical preparations and injectable suspensions. The sodium succinate salt is freely water-soluble and is the form used where rapid intravenous availability is required.

Quality Documentation — What to Request

The three forms have materially different handling requirements. Request particle size distribution and polymorph confirmation for the acetate destined for topical use, and water content by Karl Fischer for the sodium succinate, which is hygroscopic and degrades on moisture uptake. Standard documentation across all forms covers assay by HPLC, related substances, loss on drying and sulphated ash.

Import, Licensing & Logistics

Hydrocortisone APIs are not controlled substances. Standard pharmaceutical import licensing applies. Confirm whether your market requires prior API source registration before commercial import.

Three Forms, Three Uses

Hydrocortisone base, acetate and sodium succinate are not interchangeable. The base appears in oral tablets, the acetate in topical preparations and injectable suspensions where prolonged local action is wanted, and the sodium succinate wherever rapid intravenous availability is required. The succinate is the most demanding to store, being both hygroscopic and prone to hydrolysis back to free hydrocortisone in the presence of moisture.

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 Hydrocortisone 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.