IndiaUnbox connects you with audited formulation plants, API/intermediate manufacturers, sterile facilities, IVD makers, and medical-device lines across India’s life-sciences belts—delivering private-label SKUs, components, and finished products with cGMP discipline, cleanroom control, and export-ready documentation.

What we make

• APIs & Intermediates
  Small-molecule APIs, KSMs, advanced intermediates; regulated & semi-regulated markets; impurity profiles and CFR-ready DMF support (where available).
  
• Finished Dosage Forms (FDF)
  OSD (tabs/caps/ODT), liquids/suspensions, sterile & lyophilized injectables, ophthalmics/otic, semisolids (creams/ointments/gels), transdermals; nutraceuticals, herbal/AYUSH (market-allowable).
  
• Medical Devices & Disposables
  Syringes, IV sets, catheters, infusion components, wound-care dressings, surgical drapes/gowns, orthotics/braces, hospital furniture & trolleys; device sub-assemblies (PCBA, plastics, tubing, valves).
  
• Diagnostics (IVD)
  Rapid tests (lateral flow), ELISA kits, PCR assays & master mixes, specimen collection/transport media, lab plastics (tubes, tips, plates) with cleanroom molding.
  
• Biotech & Lab Reagents
  Cell-culture media & buffers, enzymes, columns, lab consumables; OEM white-label options.
  
• Packaging & Components
  Sterile barrier systems (Tyvek®/medical paper), blister & strip packs, vials/ampoules, stoppers & seals, child-resistant closures, cartons & IFUs—validated to ship.
  

Where we build (key Indian hubs)

• Hyderabad Genome Valley / Bollaram / Pashamylaram (TS) – APIs, formulations, biologics
  
• AMTZ – Visakhapatnam (AP) – med-tech park (devices/IVD/sterilization)
  
• Baddi / Nalagarh (HP) & Sikkim – formulations & consumer health
  
• Ahmedabad / Vadodara / Ankleshwar / Vapi (GJ) – APIs, intermediates, injectables
  
• Mumbai / Navi Mumbai (MH) – formulations, devices, diagnostics
  
• Bengaluru (KA) – biotech, diagnostics, cleanroom molding
  
• Chennai / Sriperumbudur / Trichy (TN) – devices, disposables, packaging
  
• Noida / Manesar (NCR) – devices, hospital furniture, IVD assembly
  

Quality & compliance (we manage, you approve)

• Systems: cGMP (21 CFR 210/211) for drugs; ISO 13485 for devices; ISO 9001/14001/45001; data integrity (ALCOA+).
  
• Devices/IVD: EU MDR 2017/745, IVDR 2017/746, UDI, Risk Mgmt ISO 14971, Usability IEC 62366, Software IEC 62304, Electrical Safety/EMC IEC 60601-1/-1-2 (where applicable).
  
• Sterilization: EtO (ISO 11135), Gamma/E-beam (ISO 11137), Steam (ISO 17665); ISO 11607 sterile-pack validation; routine bioburden & sterility assurance (SAL 10⁻⁶).
  
• Labs & testing: NABL/ISO 17025 partners; microbiology, endotoxin (USP <85> LAL), particulate (USP <788>), extractables/leachables, dissolution, assay/RS, stability (ICH Q1A).
  
• India: CDSCO/MD Rules 2017, BIS where applicable; WHO-GMP; AYUSH licensing for herbal lines.
  

Cleanrooms, validation & controls

• Classified areas: ISO 14644 Class 5/7/8 (as required) with environmental monitoring (viable/non-viable), pressure differentials & temperature/RH logs.
  
• Qualification & validation: IQ/OQ/PQ for equipment & processes; cleaning validation; aseptic media fills; process capability & hold-time studies; packaging validation (transport/ISTA as needed).
  
• QbD & risk: ICH Q8/Q9/Q10 principles; FMEA-based controls for CTQs; change control & deviation/CAPA governance.
  

Customisation & development

• Formulation: target dosage, dissolution profile, taste-masking, viscosity, preservative systems; blinding/over-encapsulation (for trials).
  
• Devices/IVD: DfM/DfX, mold/tool design for components, BOM risk & obsolescence plans; label/IFU localization; shelf-life & stability protocols.
  
• Branding: IFU/leaflet creation, UDI/GS1 barcodes, carton & label compliance panels for target markets (US/EU/UK/GCC/ANZ/LatAm).
  

Sustainability & EHS

• ZLD/ETP declarations, solvent recovery %, energy KPIs; latex-free/nitrile options; recyclable packs; EPR support (India).
  
• Ethical sourcing: RMI-style declarations for metals in devices; no conflict minerals in electronics.
  

Typical MOQs & lead times (guidance)

• APIs/intermediates: 25–500 kg per lot; lead 4–8 weeks (route & RM dependent).
  
• OSD/Liquids/Semisolid: 50k–200k units/SKU; lead 4–8 weeks after artwork & stability plan.
  
• Sterile injectables/opthalmics: 10k–100k units/SKU; lead 8–12 weeks incl. media fills.
  
• Disposables/devices: 5k–50k pcs/SKU; lead 4–8 weeks (tooling adds 3–5 weeks).
  
• IVD kits: 5k–20k tests/SKU; lead 4–6 weeks post verification.
  (Cross-factory consolidation available under one QC/dispatch.)
  

Cold chain, packing & logistics

• Controlled temperatures: 2–8 °C / 15–25 °C / –20 °C lanes as required with calibrated data loggers & shipper qualification.
  
• Sterile barrier: validated pouches/rigid trays, EO-aeration or radiation-released lots; DHR/lot cards on every carton.
  
• Docs & shipping: MSDS/SDS, COA/COC, health certificates, Form-X as relevant; insurance & product liability options.
  

Our sourcing workflow (life-sciences edition)

1. Brief & NDA – product list/specs, target markets & approvals (FDA/CE/CDSCO), pack sizes, forecast.
   
2. Shortlist – plant capability matrix (licenses, cleanroom classes, sterilization, lab scope).
   
3. Samples/Exhibit – lab batches or engineering builds; method validation & verification plan.
   
4. Qualification – process validation, shelf-life/stability, sterilization validation, packaging validation; golden standard lock.
   
5. Production & QC – in-process & release testing, retain samples, DHR/BMR packs.
   
6. Ship – cold-chain and sterile-pack controls, destination paperwork, post-market support plan.
   

Risk controls we enforce

• Data integrity (ALCOA+), audit trails, restricted access; periodic internal audits.
  
• Sterility & bioburden gates before release; endotoxin limits for invasive use devices.
  
• Extractables/leachables and materials biocompatibility (ISO 10993) for device contact parts.
  
• UDI/label governance with version control & barcodes; IFU readability & language checks.
  
• Supplier qualification for critical RMs (stoppers, films, tubing, reagents) with CoA/CoC.
  
• Change control & regulatory impact assessment before any spec/process shift.
  

Documentation you receive

• DMF/ASMF references (where available), CoA & full BMR/BPR/DHR copies, validation reports (IQ/OQ/PQ, sterilization, cleaning, packaging), stability data, method validation, biocompatibility & E&L (where applicable), UDI/label proofs, calibration & environmental logs, loading supervision report, insurance & origin docs.
  

Case snapshots (illustrative)

• EU private-label wound care: island dressings & film drapes; EtO validated (ISO 11135), ISO 11607 pack; CE tech file prepared; complaint rate <0.6% over 12 months.
  
• US nutraceutical tablets: OSD line with FSSC 22000 + cGMP; dissolution matched to spec; child-resistant packs; FSVP dossier provided.
  
• GCC IVD brand: LFIA rapid tests with OEM branding; shelf-life 18–24 months; stability & verification reports; Arabic/English IFUs.
  

Micro-FAQ

• Can you support CE/FDA filings? We provide tech files, test reports, UDI/labels and liaise with labs; legal manufacturer/agent arrangements as per your strategy.
  
• Do you do sterile only? We handle both sterile and non-sterile; sterilization via EtO/Gamma/Steam with routine dose/aeration records.
  
• Biocompatibility/E&L? Managed through ISO 10993 panel and USP/E&L studies via accredited labs.
  
• Can I mix SKUs in one shipment? Yes—plant policy permitting; we also consolidate cross-factory under unified QC.
  
• IP protection? NDA, controlled access, segregated batch records and material custody.
  

Ready to brief? Share your target markets & approvals (FDA/CE/CDSCO), product list/specs, pack sizes, stability/sterility expectations, and first delivery window. We’ll revert with a plant shortlist, validation roadmap, and a clear timeline to shipment.