Progesterone API Supplier India | 2 Grades | Bulk Export

Aarise Pharmaceuticals supplies progesterone and hydroxyprogesterone caproate as bulk hormone APIs from India.

Available Progesterone Grades

Choosing the Right Grade

Progesterone is the natural progestogen and is poorly absorbed orally unless micronised, which is why micronised grades exist specifically for oral and vaginal formulation. Hydroxyprogesterone caproate is an esterified derivative formulated in oil for intramuscular administration with extended release.

Quality Documentation — What to Request

For progesterone intended for oral or vaginal use, particle size is the parameter that determines bioavailability, and a micronised grade should be specified explicitly rather than assumed. Request particle size distribution, assay by HPLC, related substances and loss on drying. For the caproate ester, free progesterone content and residual solvents are the figures to check.

Import, Licensing & Logistics

Progesterone APIs are not generally controlled substances but do attract pharmaceutical import licensing. Several markets require prior registration of the API source before commercial import.

Micronisation and Oral Bioavailability

Unmicronised progesterone is poorly absorbed orally, which is why micronised grades exist specifically for oral and vaginal formulation. Particle size is the parameter that determines bioavailability, and a micronised grade must be specified explicitly rather than assumed. Hydroxyprogesterone caproate, by contrast, is formulated in oil for intramuscular use and the relevant figure there is free progesterone content.

Stability, Storage & Retest

Steroid hormones are stable as dry powders but several are photosensitive and oxidise on prolonged air exposure. Micronised grades have a much larger surface area and degrade faster than unmicronised material, so a micronised grade should be used within a shorter retest interval and stored under nitrogen where the specification calls for it. Confirm the retest date on the Certificate of Analysis rather than assuming a standard shelf life.

Export Process & Lead Time

Hormone APIs are not generally scheduled as controlled substances, though a small number of progestogens attract additional documentation in specific markets. Standard pharmaceutical import licensing applies in most destinations. A growing number of markets, including Brazil, Russia and several Gulf states, require prior registration of the API manufacturing source before any commercial import is permitted, which is a process measured in months rather than weeks.

Incoming Goods Inspection

Incoming checks should cover appearance, identification, assay and particle size distribution where a micronised grade has been specified. For material going into transdermal or vaginal delivery systems, confirm the polymorphic form on receipt, since polymorph affects flux through the delivery matrix and a different form will change the release profile of a validated product.

Ordering Progesterone 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.