Why India: the world’s deepest bench of Ayurvedic botanicals (ashwagandha, turmeric/curcumin, boswellia, amla, tulsi) + a mature extraction and contract-manufacturing base. India exported ~US$1.03 billion of vegetable saps & extracts (HS 1302) in 2023—much of it nutraceutical actives—led by shipments to the US (~US$430 M), Russia, and Germany. Separately, Ayush & herbal product exports were ~US$651 M in FY 2023–24.
What we can build for you (illustrative)
- Capsules & tablets: single-herb (e.g., ashwagandha, boswellia), standardised actives (curcuminoids %, withanolides %), multi-vitamin + botanicals within RDA caps.
- Powders & sachets: greens/moringa blends, collagen + herb stacks*, protein + botanicals*, instant kadha/infusion mixes (*formulation feasibility depends on destination rules).
- Herbal extracts: water/ethanolic CO₂ extracts; full-spectrum and marker-standardised (HPTLC/HPLC); oleoresins where relevant.
Positioning choices: food-grade nutraceuticals (FSSAI/US/EU supplement rules) or Ayurvedic medicines (licensed under AYUSH & Schedule-T GMP). We help you pick the right route per market.
Compliance you can rely on (India • US • EU)
- India (FSSAI nutraceuticals): We formulate and label to the Food Safety & Standards (Health Supplements, Nutraceuticals, FSMP/FF/Novel Food) Regulations, 2022, using ICMR-NIN RDA-2020 limits. Pack copy, claim wording, and ingredient lists are red-lined before print.
- US dietary supplements: We build Supplement Facts panels per 21 CFR 101.36 and manufacture under 21 CFR 111 dietary-supplement cGMP. Structure/function claim and disclaimer formatting included.
- EU food supplements: We align to Directive 2002/46/EC (vitamins/minerals lists), Reg. 1924/2006 (nutrition/health-claims—evidence required), and check Novel Foods Reg. 2015/2283 where a botanical/prep may be novel in the EU.
- AYUSH medicines (if you choose the drug route): We source from plants following Schedule-T GMP; for export credibility we can add QCI AYUSH Standard/Premium Mark certification.
Quality & safety we lock before you launch
- Identity & potency: marker assays (e.g., withanolides, curcuminoids, boswellic acids) by HPTLC/HPLC; assay specs agreed per SKU.
- Contaminants: pesticide and heavy-metal panels, aflatoxins (for botanicals), microbiology (TPC/yeast-mould/pathogens); residual-solvent checks on extracts.
- Stability & format: real-time/accelerated studies; capsule shell compatibility; desiccant selection for sachets/bottles.
- Documentation pack: CoA per lot; ingredient DoCs; cGMP/FSMS (e.g., FSSC 22000/BRCGS) certificates; claim substantiation file (EU/US label logic).
How IndiaUnbox makes it easy (end-to-end)
- Brief → regulatory route: Decide “FSSAI nutraceutical” vs “AYUSH medicine” vs export-only supplement; map allowed ingredients/levels and claim language per destination.
- Supplier shortlisting: Curate extractors and contract manufacturers with export track records (HS 1302 focus) and the right certifications (FSSC/BRCGS; 21 CFR 111 familiarity; Schedule-T for AYUSH).
- Prototype & lab: lock sensory/flowability, capsule disintegration, marker potency; run full contaminant panels and stability.
- Label & claims check: FSSAI RDA-2020 mapping for India; Supplement Facts (US); EU claims/novel-food screening; multilingual packs and e-com copy.
- Price & timing: benchmark to extract prices and freight; tie buys to harvest windows; negotiate passes when HS 1302 indices soften.
- Packaging & logistics: HDPE/PET with induction seals, desiccants; blister/strip where needed; ISTA-tested shipper cartons; export paperwork.
Typical MOQs & lead times (guide)
- Capsules/tablets: 50k–200k caps per SKU • 45–70 days post-approval
- Powders/sachets: 1,000–10,000 canisters or 50k–300k sachets • 45–70 days
- Bulk extracts: 100–1,000 kg lots • 30–50 days
Suggested stat badges for the webpage
- US$1.03 B India exports of vegetable saps & extracts (HS 1302, 2023) • Top buyer: USA.
- US$651 M Ayush & herbal products exports (FY 2023–24).
- FSSAI Nutraceutical Rules 2022 + RDA-2020 limits applied.
- US 21 CFR 111 cGMP • 21 CFR 101.36 Supplement Facts • EU 2002/46/EC & 1924/2006 claims checks • EU 2015/2283 novel food screen.
- AYUSH route: Schedule-T GMP + optional QCI AYUSH Premium Mark.