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Capabilities & infrastructure

One facility. Every step.

Formulation, sterile fill-finish, clinical bioequivalence and regulatory market access — all delivered end-to-end from one WHO-GMP facility at MEPZ-SEZ Chennai.

The four pillars

End-to-end, under one roof.

Vertical integration isn't a slogan — it's how we control quality, cost and timelines on every batch. Formulation through filing, lab through launch, all on one campus.

Pillar / 01

Formulation

Stable parenteral formulations developed by container-closure format — preservative system, isotonicity, buffering and protein-stability profile engineered per molecule and route of administration.

  • Three 50 L formulation vessels for buffer prep and bulk solution
  • Excipient compatibility and protein-stability studies in-house
  • Container-closure qualification for vials, cartridges, PFS & pens
  • Lyophilisation capability for sensitive injectables
Pillar / 02

Sterile Fill-Finish

30,000 sq ft purpose-built sterile facility at MEPZ-SEZ Chennai. Combi line handles three primary container types from one floor.

  • 3,600 units / hour combi-line throughput
  • Vials · cartridges · pre-filled syringes in a single line
  • Class A / B cleanrooms with continuous environmental monitoring
  • Isolator-based aseptic filling for sensitive molecules
Pillar / 03

Clinical & Bioequivalence

Comparative bioequivalence and PK/PD studies executed against innovator reference products per ICH E6 (GCP) — supporting biosimilar approval pathways across regulated markets.

  • Phase I / III BE study design and execution
  • CRO partnerships for healthy volunteer trials
  • Pharmacokinetic / pharmacodynamic end-point analysis
  • Reference-product procurement across global suppliers
Pillar / 04

Regulatory & Market Access

Dossier preparation, country registration and lifecycle management — covering CDSCO India plus active export markets across four regions.

  • CTD / eCTD dossier compilation and submission
  • CDSCO India filings, MA & manufacturing licences
  • Country registrations across CIS, LATAM, Africa, SEA, ME
  • Post-marketing surveillance and pharmacovigilance
Delivery formats

Built for every patient.

From standard vials for hospital use to disposable pens for home administration — we manufacture across the full range of sterile injectable presentations.

3 mL, 5 mL and 10 mL clear glass injection vials with aluminum crimp caps
Format 01

Vials

Sterile injectable vials for hospital and clinic administration.

  • GlassType I borosilicate, tubular
  • Sizes3 mL · 5 mL · 10 mL
  • ClosureBromobutyl stopper · Al flip-off seal
  • ComplianceUSP <660> · Ph. Eur. 3.2.1
3 mL pen-fill glass cartridges for reusable insulin pens
Format 02

Cartridges

Pen-fill cartridges for reusable insulin and GLP-1 injector systems.

  • GlassType I borosilicate, siliconized
  • Volume3 mL pen-fill
  • ClosureBromobutyl plunger · Al crimp ring
  • ProfileLow-tungsten · low-extractables
Pre-filled syringes with stainless-steel needles for single-dose administration
Format 03

Pre-Filled Syringes

Ready-to-administer single-dose syringes for biosimilars and anticoagulants.

  • GlassType I borosilicate, siliconized
  • Needle27G staked · rigid needle shield
  • ProfileLatex-free · tungsten-controlled
  • ComplianceISO 11040
Disposable insulin pen injectors with built-in cartridge reservoir
Format 04

Disposable Pens

Pre-assembled single-use injectors for at-home self-administration.

  • ReservoirIntegrated 3 mL Type I cartridge
  • Dosing1 IU increments · dose memory
  • FeedbackAudible click on dial
  • NeedlesUniversal pen-needle compatible
Quality framework

Certified at every level.

Regulatory readiness woven into operations — WHO-GMP at the global level, DCGI for India, Schedule M for the latest Indian standards, and ALCOA+ governing every data entry.

WHO-GMP

World Health Organisation
Good Manufacturing Practice

DCGI

Drug Controller General
of India

Schedule M

Latest Indian GMP
standard (2024)

ALCOA+

Data integrity standards
across the value chain

Coming online · 2026

New capacity, online by Q3 2026.

Active capacity expansion across formulation, filling and air-handling — adding new equipment that significantly expands batch size, line capacity and clean-air coverage. Commissioning concludes with full media fill validation.

Formulation

350 L Process Vessel

Significantly larger batch capacity for biosimilar formulation — a 7× step-up from the existing 50 L vessels.

  • Magnetic mixer drive
  • Vibro-mixer for sensitive proteins
  • Full IQ / OQ qualification
Fill-Finish

New Filling Lines

Dedicated filling capacity across two parallel lines — adding throughput across primary container formats.

  • Cartridge filling machine
  • Z-axis vial filling & stoppering machine
  • Cleanroom-grade installation & PQ
Clean Air

HVAC & LAF Upgrade

Expanded clean-air coverage across manufacturing and filtration zones — full HEPA / ACPH / NVPC qualification.

  • Two upgraded AHU systems
  • Two new laminar air flow (LAF) units
  • Static & dynamic PQ studies
Why it matters

Vertical integration is the moat.

Most biosimilar companies outsource at least one critical step — formulation, fill, clinical or regulatory. Every handoff adds time, cost and quality risk.

Regenix delivers all five under one roof. One quality system, one project timeline, one team accountable from concept to commercial launch.

01

Formulation

Bench & pilot · 50 L–350 L vessels

02

Sterile Fill-Finish

Combi line · 3,600 units/hour

03

Bioequivalence

Phase I / III vs innovator

04

Regulatory Filing

CTD / eCTD · 40+ markets

05

Commercial Launch

Country-by-country roll-out

Partner on capacity, dossiers or development.

Out-licensing, in-licensing, contract manufacturing, dossier transfer — tell us what you need and we'll send a tailored proposal within 48 hours.

Partnership models → Contact business development