Pharmaceutical API Supplier in India
Five-hundred-and-sixty active pharmaceutical ingredients, intermediates, peptides, and veterinary compounds — manufactured in Pune to WHO-GMP, ISO 9001:2015, US FDA DMF, and EDQM CEP standards, shipped to procurement teams in 50+ countries.
Who buys from Longshine Boi-Tech
We supply generic drug manufacturers, contract development & manufacturing organisations (CDMOs), research institutions, veterinary pharma houses, and regulated-market importers in the United States, Canada, Mexico, Brazil, the European Union, the United Kingdom, Japan, Australia, the Middle East, and South-East Asia.
Typical buyers reach us when they need:
- Replacement API source — when their current supplier loses CEP or gets an FDA Form-483 observation, and they need a qualified backup with an active DMF.
- Cost-down sourcing from Pune for a molecule currently bought from a higher-cost European or Japanese manufacturer.
- CDMO partner for custom synthesis, scale-up, or full contract manufacturing of a proprietary molecule.
- Audit-ready documentation — DMF reference letters, CEP certificates, GMP certificates, and per-SKU CoAs for regulatory submission.
Why buy from India — and specifically Pune
India produces roughly 40% of the world’s generic API supply, and Pune is one of India’s densest pharmaceutical clusters: it hosts more than 300 manufacturing units, three major API export estates, and direct rail and air links to the deep-water container terminal at JNPT, Mumbai (90 minutes by road).
For buyers, that translates into:
- Lower per-kilogram cost than China, EU, or Japan for most workhorse molecules, without the geopolitical risk currently attached to Chinese API supply.
- Faster CMC submissions, because most Pune manufacturers carry active DMFs, CEPs, and ASMFs ready for Letter of Authorization (LoA) at no extra fee.
- Mature regulatory relationship: India’s CDSCO licensing is recognised by FDA, EDQM, ANVISA, PMDA and TGA.
- English-language quality and regulatory documentation as a default.
Certifications & regulatory portfolio
- WHO Good Manufacturing Practice (WHO-GMP) — full Pune facility, renewed annually since 2014.
- ISO 9001:2015 — Quality Management System, continuous since 2011.
- US FDA Drug Master Files (Type II) — 60+ active DMFs covering APIs and key intermediates.
- EDQM Certificate of Suitability (CEP) — multiple molecules with active CEP dossiers.
- CDSCO manufacturing licence — Pune facility, valid through 2028.
- Pharmacopoeial compliance — USP, Ph. Eur., IP, JP — per-SKU release specs available.
The full certifications portfolio and downloadable quality system overview are public.
Explore the catalogue
Frequently asked questions
How long does first-shipment lead time take?
Most stocked APIs ship within 7-10 business days of a confirmed PO. Custom synthesis or new-molecule scale-up adds 4-8 weeks for process validation. Air freight to North America runs 4-5 days door-to-door; sea freight 18-25 days.
Will you sign an exclusivity / supply agreement?
Yes. We sign multi-year supply contracts with volume commitments, indexed pricing, and supply-failure penalties on a case-by-case basis. Typical agreement length is 24-36 months.
Can you supply a Letter of Authorization for your DMF / CEP?
Yes — once a supply agreement is in place, we issue LoAs at no charge for the customer’s regulatory filings. The LoA references the active DMF (FDA) or ASMF (EU) and grants the customer the right to cite our manufacturing process in their drug-product submission.
What payment terms do you offer?
New customers: 30% advance, 70% against shipping documents. Established customers: net-30 to net-90 against irrevocable LC or trade-credit-insured invoice. We accept USD, EUR, GBP, INR and stablecoin (USDT, USDC) payments.
Do you offer samples?
Yes — 1g to 50g samples ship within 5 business days of a sample request. Bulk QC samples (100g+) for customer qualification are also available against a sample agreement.
Talk to a sales engineer
First response within 4 business hours, Pune time (IST). We can also run a teams call inside your working hours — most weekday hours across the US, EU, LATAM and APAC are covered.