Pharma Ingredients & CDMO · United States
Importing APIs, excipients, intermediates and contract manufacture from India to the United States
Active pharmaceutical ingredients, excipients and pharmaceutical intermediates sold as bulk material against a specification, plus CDMO and CMO contract-manufacturing capability sold as access to a site and a process. Finished dosage forms bound for the United States are explicitly excluded: a finished drug product needs an ANDA or NDA holder of record, state-level wholesale distributor licensing and DSCSA serialization at the unit level, none of which Indiasay holds or arranges. What a buyer qualifies here is the substance and the site, not a brand.
HS classification
HS Chapter 29 (organic chemicals) for most bulk actives, intermediates and synthetic excipients; HS Chapter 28 for some inorganic actives. HS 3003/3004 (formulated, dosed medicaments) does not apply to anything in this category — see the exclusion below.
Documentation for United States
- FDA drug establishment registration and product listing (21 CFR Part 207) for the manufacturing site, filed through FURLS — required before an API or excipient manufactured there enters US commerce
- A Type II Drug Master File (DMF) filed with FDA for the API — a confidential reference file a US formulator cites in their own ANDA/NDA; filing it does not itself constitute FDA approval or review, and the DMF's status (active/inactive) is separate from whether any formulator has referenced it
- GDUFA facility fee, where the site is identified in an approved or pending ANDA that references it
- Certificate of Analysis per batch, and a Safety Data Sheet in GHS format
A DMF number existing is not the same fact as the DMF being active, and neither is the same fact as the site having passed a US FDA inspection — this platform states each of the three separately, with a date, rather than inferring one from another.
Certifications that matter
Order volume and shipping
Courier for regulatory/development-quantity samples; air freight for early qualification lots; ocean freight (drums, fibre drums, IBC totes) for commercial-scale API and excipient volumes. CDMO/CMO capability has no shipping mode of its own — output ships under whichever mode its finished output requires.
Indiasay listings are built to be orderable from a single sample unit — MOQ and lead time are set per product, not per category, so test before committing to volume.
Order sizes we serve
Sample
from $200
E-commerce restock
200–500 units
Pallet
distribution volume
Container
full load
The fastest-growing buyer for APIs, excipients, intermediates and contract manufacture landed in the United States is an Amazon FBA, Shopify, Etsy or TikTok Shop seller restocking 200–500 units at a time, not a distributor buying by the pallet — landed cost is quoted per unit, in USD, so it can be checked directly against a marketplace listing price. Amazon FBA prep — labelling, polybagging and carton marking to the destination fulfilment centre's requirements — is arranged per order; confirm the exact prep specification for your listing before dispatch, since it varies by product and by Amazon's own current requirements.
Listings
No APIs, excipients, intermediates and contract manufacture suppliers are listed yet.List yours first →
Looking for a specific product, or a supplier not listed yet?
Request accessPharma Ingredients & CDMO — United States FAQ
What HS code does APIs, excipients, intermediates and contract manufacture fall under when exporting from India?+
APIs, excipients, intermediates and contract manufacture typically falls under: HS Chapter 29 (organic chemicals) for most bulk actives, intermediates and synthetic excipients; HS Chapter 28 for some inorganic actives. HS 3003/3004 (formulated, dosed medicaments) does not apply to anything in this category — see the exclusion below..
What documentation is required to import APIs, excipients, intermediates and contract manufacture from India into the United States?+
Importing APIs, excipients, intermediates and contract manufacture into the United States requires: FDA drug establishment registration and product listing (21 CFR Part 207) for the manufacturing site, filed through FURLS — required before an API or excipient manufactured there enters US commerce; A Type II Drug Master File (DMF) filed with FDA for the API — a confidential reference file a US formulator cites in their own ANDA/NDA; filing it does not itself constitute FDA approval or review, and the DMF's status (active/inactive) is separate from whether any formulator has referenced it; GDUFA facility fee, where the site is identified in an approved or pending ANDA that references it; Certificate of Analysis per batch, and a Safety Data Sheet in GHS format.
What certifications matter when importing APIs, excipients, intermediates and contract manufacture from India to the United States?+
The certifications that matter are: US FDA site inspection outcome (NAI/VAI/OAI) where the site has been inspected, CEP / EDQM Certificate of Suitability, where filed, though this is a European instrument, not a US requirement, cGMP manufacturing (21 CFR Parts 210/211).
Is APIs, excipients, intermediates and contract manufacture regulated as a food, a drug, or something else in the United States?+
A DMF number existing is not the same fact as the DMF being active, and neither is the same fact as the site having passed a US FDA inspection — this platform states each of the three separately, with a date, rather than inferring one from another.
How is APIs, excipients, intermediates and contract manufacture shipped from India?+
Courier for regulatory/development-quantity samples; air freight for early qualification lots; ocean freight (drums, fibre drums, IBC totes) for commercial-scale API and excipient volumes. CDMO/CMO capability has no shipping mode of its own — output ships under whichever mode its finished output requires.
Can I order a sample of APIs, excipients, intermediates and contract manufacture before committing to a full container?+
Indiasay listings are built to be orderable from a single sample unit or a small mixed set from USD 200, at the supplier's wholesale rate — MOQ and lead time are set per product, not per category, so a buyer can test before committing to pallet or container volume.