Capabilities / Lyophilization
Freeze-drying built for molecules that can't tolerate liquid form.
Oncology, anesthesia, and critical-care injectables that are unstable in solution are freeze-dried at the Tarapur facility — a capability the plant has carried since 2009 (date pending confirmation).
3.5M oncology lyophilized units/yr · 10M general lyophilized units/yr (capacity figures pending confirmation) · Tarapur, Maharashtra
Why freeze-dry
Some injectables don't survive as liquids
A number of oncology and critical-care molecules degrade in aqueous solution well before a usable shelf life is reached. Lyophilization — freezing a formulation and then drawing off the water under vacuum — leaves a stable, sterile cake that is reconstituted by the clinician immediately before use. It is a slower, more capital-intensive process than liquid filling, and it is the process this plant was built to run for exactly the molecules that require it.
The process
Four stages, one continuous sterile chain
- 1
Formulation & fill
The sterile bulk solution is compounded and filled into vials under Grade A conditions, partially stoppered ahead of drying.
- 2
Freezing
Vials are cooled on temperature-controlled shelves until the solution is fully solidified, the foundation step that determines cake structure.
- 3
Primary & secondary drying
Under vacuum, ice is sublimated directly from solid to vapor (primary drying), then residual bound moisture is driven off at a controlled temperature ramp (secondary drying) to reach the target moisture specification.
- 4
Stoppering, capping & inspection
Vials are fully seated under vacuum or inert gas, capped, and passed through in-line inspection before release testing. Cycle parameters are validated per product — a shared four-stage sequence, not a shared cycle.
Capacity
Purpose-built oncology capacity, plus general-injectable lyophilization
Installed lyophilization capacity at Tarapur is split across two lines: 3.5M oncology lyophilized units/yr and 10M general (non-oncology) lyophilized units/yr. These figures are carried over from company production records and are marked pending confirmation until re-verified against current output data.
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3.5 M
Oncology lyophilized units/yr
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10 M
General lyophilized units/yr
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30
Lyophilized SKUs in catalog (15 oncology)
Pending approval Capacity figures are carried from company production records and are pending confirmation.
30 lyophilized injectables in the current portfolio
Thirty products across the FDF catalog are formulated and released as lyophilized injections, fifteen of them in oncology. Each carries its own validated cycle, pharmacopoeial reference, and market-specific dossier status — filterable in the full product catalog.