Gland B2B Business Model and Growth Strategy
Generic Injectables: Market Entry Barriers
2
Manufacturing Complexities to Meet
Stringent Quality Standards
Complexities involving sterilisation, packaging,
sterile fill/finish, with stability assessment at each
stage, among others
3
High Level of Compliance and
Regulatory Requirements
High level of regulatory enforcement of cGMP
standards
1
Significant Capital Investments
Injectable plants require 1.3x - 1.5x more capex
vs oral solids plants due to requirements of
sterilisation and/or aseptic manufacturing
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4
Stringent Quality Requirements
c.62% of drugs in shortage are associated with
manufacturing or product quality problems
For the US Generic Injectables Market, c.70% of the Market by Value has
Less than Half the Number of Manufacturers Compared to the Oral Solids Segment
Source: IQVIA Report.
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