About us
India-sourced pharmaceutical trade, globally distributed
SPK Pharma India is a Mumbai-based B2B pharmaceutical trading and distribution company. We source generic APIs, finished dosage forms, intermediates, and clinical trial materials from a partner manufacturing network in India, and supply licensed distributors, manufacturers, hospital procurement, and institutional buyers across 40+ destination countries.
Service lines
What we trade
Generic API Supply
Off-patent active pharmaceutical ingredients manufactured under WHO-GMP. Drug license verification required for every shipment.
Finished Dosage Forms
Tablets, capsules, injectables, and other finished formulations for licensed distributors, hospital procurement, and institutional buyers.
Orphan & Specialty Medicine Sourcing
Rare-disease and specialty medicines sourced globally for named-patient supply, compassionate use, and parallel-import licensing.
Clinical Trial Material Supply
Comparator drugs, rescue medications, co-medications, and investigational product supply with full documentation and global shipping.
Contract Manufacturing Coordination
Coordination with WHO-GMP, US-FDA, and UK-MHRA approved manufacturing facilities for branded generics, vaccines, and neutral-label products.
Parallel Import & Named-Patient Supply
Cross-border sourcing for unmet medical need, parallel import licensing, and named-patient programmes in 40+ destination countries.
Government & Institutional Tenders
Tender participation for government procurement, public health programmes, and institutional buyers. RCMC and IEC documentation maintained.
How we operate
Source
We work with a partner manufacturing network in India operating to WHO-GMP aligned production standards for generic APIs, finished dosage forms, and clinical trial materials. Sourcing decisions follow the Drugs and Cosmetics Act 1940 and Rules 1945, including Schedule T for Indian GMP.
Verify
Every batch ships with a lot-matched Certificate of Analysis documenting identity, purity, and contamination control. Pharmacopoeial compliance to USP / EP / BP / IH as applicable. MSDS supplied with every shipment. Third-party verification on representative samples per lot.
Ship
Validated cold-chain packaging, customs documentation pre-prepared (Certificate of Origin via Pharmexcil, commercial invoice, packing list, IEC-cleared shipment), and tracked transit to 40+ countries. Our trade desk coordinates with the buyer's import broker where required.
Regulatory framework
All transactions are governed by the Indian pharmaceutical trade framework. We operate under the following:
- •Drugs and Cosmetics Act 1940 and Rules 1945 — the principal Indian legislation governing the import, manufacture, distribution, and sale of drugs and cosmetics. State FDA licenses issued under this Act authorise wholesale trade within India.
- •DGFT (Directorate General of Foreign Trade) — Import Export Code (IEC) is the mandatory 10-digit code for any entity engaged in international trade in India. Issued under the Foreign Trade (Development and Regulation) Act, 1992.
- •Pharmexcil (Pharmaceuticals Export Promotion Council of India) — statutory export promotion body set up by the Ministry of Commerce. RCMC (Registration Cum Membership Certificate) is the standard credential for Indian pharmaceutical exporters.
- •WHO-GDP (Good Distribution Practice) — WHO guidelines for the proper distribution of pharmaceutical products, covering storage, transportation, and traceability.
- •Schedule T / WHO-GMP — Indian and WHO Good Manufacturing Practice standards applied across our partner manufacturing network.
Buyers are responsible for compliance with all applicable laws and regulations in their destination jurisdiction, including but not limited to import licensing, controlled substance regulations, prescription requirements, and end-user record-keeping.
B2B only — no consumer sales
SPK Pharma India sells exclusively to qualified trade buyers: licensed pharmaceutical distributors, registered manufacturers, formulation laboratories, hospital procurement, and research institutions. Every product in our catalogue is sold with explicit regulatory positioning appropriate to its legal status — patented innovator molecules as clinical trial supply, off-patent molecules as generic APIs, approved drugs against valid prescription, and research compounds as laboratory reference materials.
We do not sell to consumers. We do not market to end users. We do not make therapeutic, clinical, or dosing claims. Our business is B2B-only.