India Pharma ExportTrusted Medicines. Healthier Tomorrow.
NOC / ConditionalHospital / Professional Use

Rare Disease, Orphan & Specialty Biologics

India is becoming a serious source of affordable enzyme replacement and orphan therapies.

HS Code: 3002 / 3004.90Markets: Gulf, Latin America, SE Asia, named-patient supplyMolecules Tracked: 48

What This Class Covers

Enzyme replacement therapy and orphan-disease biologics, offered largely as named-patient or compassionate-use supply — precisely the case an Export NOC exists for. Expect purchase-order-specific quantities and a heavier documentation load than standard generics.

Export Status Notes

Much of this trade moves as named-patient or compassionate-use supply — expect purchase-order-specific quantities and heavy documentation.

Prescription Status Notes

Not retail-dispensed.

Full Molecule List

Agalsidase alfa

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Agalsidase beta

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Alglucosidase alfa

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Asfotase alfa

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Ataluren

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Betaine anhydrous

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Burosumab

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C1-esterase inhibitor

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Carglumic acid

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Chenodeoxycholic acid

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Cysteamine

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Deflazacort (DMD)

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Eculizumab

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Edaravone

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Elapegademase

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Eliglustat

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Elosulfase alfa

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Eteplersen

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Hydroxocobalamin (MMA)

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Icatibant

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Idursulfase

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Imiglucerase

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Inotersen

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Lanadelumab

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Laronidase

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Levocarnitine

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Metreleptin

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Migalastat

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Miglustat

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Nitisinone

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Nusinersen

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Patisiran

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Pegvaliase

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Ravulizumab

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Riluzole

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Risdiplam

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Sapropterin

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Sebelipase alfa

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Sodium benzoate

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Sodium phenylbutyrate

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Tafamidis

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Taliglucerase alfa

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Teduglutide

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Trientine

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Ursodeoxycholic acid

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Velaglucerase alfa

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Vosoritide

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Zinc acetate (Wilson disease)

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Showing 48 of 48 molecules tracked in this class. Contact us for a specific molecule not listed here.

Export and prescription status vary by molecule, strength, pack size and destination. Verify current requirements with the relevant authority before shipment.
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