APIs & Bulk Drugs Supplier in United States
Active pharmaceutical ingredients and bulk drugs sourced from Indian manufacturers, with COA, pharmacopoeial specs and regulatory documents on request. Formulation and generic manufacturers in United States source APIs from us with batch COAs and, where the producing site holds them, DMF or CEP support.
APIs & Bulk Drugs for United States
The APIs and bulk drugs division supplies active pharmaceutical ingredients across major therapeutic classes, including anti-infectives, cardiovascular, antidiabetic, analgesic, gastrointestinal and CNS molecules. India is one of the world's largest API producing countries, and we source from manufacturers in established clusters such as Hyderabad, Vizag, Gujarat and Maharashtra.
Materials are offered to IP, BP, USP or Ph. Eur. monographs, or to in-house specifications where no monograph exists. Every shipment carries the manufacturer's batch COA and a GHS SDS. Depending on the product and the producing site, supporting documents such as a DMF letter of access, CEP, GMP certificate, EU written confirmation, TSE/BSE and residual solvent statements may be available. Availability is confirmed per product before you order, never assumed. We also help buyers assemble sample quantities for pre-qualification testing before a commercial order is placed.
Formulation manufacturers, generic companies developing dossiers, compounding and veterinary producers, and research groups needing reference quantities are the main buyers. Import of APIs is regulated in almost every market, so importers should confirm local licence, registration and site-approval requirements. We provide documents in the format the buyer's regulatory team requests where the manufacturer allows it.
Grades available
Compliance in United States
Regulator: FDA (CDER)
Chemical substances imported into the US must comply with the Toxic Substances Control Act, and the importer files a TSCA positive or negative certification at entry. Substances must be on the TSCA Inventory or exempt. APIs for human drugs are FDA-regulated, typically supported by a Drug Master File and cGMP manufacturing, and are subject to FDA entry review (FSVP applies to food, not chemicals). List I and List II chemicals require DEA import registration and declarations, and ocean shipments need an ISF 10+2 filing with CBP before loading.
Shipping lanes
- New York / New Jersey
- Houston
- Savannah
- New York JFK (JFK)
- Chicago O'Hare (ORD)
Typical buyers: Finished dosage formulators, Generic dossier developers, Veterinary drug manufacturers, Nutraceutical and compounding companies, Pharma distributors and importers, R&D and pilot-scale labs.
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FAQs — APIs & Bulk Drugs in United States
Do you supply APIs & Bulk Drugs to United States?
Yes. We export APIs & Bulk Drugs to United States by sea freight to New York / New Jersey or Houston, by air cargo, or by express courier for small R&D packs. Every shipment includes a COA and a GHS SDS.
How long does delivery to United States take?
Typical sea transit from India to United States is 28–40 days and air freight 3–6 days, plus production/packing lead time and customs clearance.
Can you provide a DMF or CEP for an API?
It depends on the product and the manufacturing site. Where the manufacturer holds a US DMF, CEP or other filing, a letter of access or copy can often be arranged. We confirm availability per product before quoting.
Which pharmacopoeial standards do your APIs meet?
APIs are offered to IP, BP, USP or Ph. Eur. monographs as stated on the quotation and COA, and to manufacturer specifications where no monograph applies.
Do I need an import licence to buy APIs?
In most countries yes. Importers typically need a drug import or wholesale licence and sometimes site registration of the manufacturer. Please check requirements with your local regulator before ordering.
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APIs & Bulk Drugs quote — United States
We reply within one business day with price, pack options, lead time and documentation.