Gland B2B Business Model and Growth Strategy
...Supported by Proven Regulatory Capabilities
Product Development Capabilities Supported by Regulatory Expertise and Track Record in Filing and
Approval of Large Number of Product Registrations
28
Established Expertise
Broad Range of Filings
Successful track record and pipeline
Constantly engaged with regulators including the USFDA
Geographic Breakdown
(FY21)
Total 284 ANDAS (1)
Different jurisdictions
☐ Diverse dosage forms
■ ANDA filings for sterile
injectables (204), oncology
(53), ophthalmics (27)
50
284
20
234
30
170
150
60%
64%
84
36%
40%
114
RoW
16%
Approved
Pending
Total
Australia
0.5%
Owned Partner Owned
Canada
2%
Revenue
Supportive filings to drive
sustainability
■ Undertaking CBE filings for
site and line changes
■Timely filing of applications
like CBE/PAS for alternate
APIs and components
Global Platform of Approved and Filed Registrations
Extensive experience in regulatory requirements of key markets to
facilitate new product registrations
Total 1,478 Product Registrations Globally1
1043
Europe
4%
from
operations
India
16%
*34bn
US
61%
389
US, Canada,
Europe, Australia
Note: (1) Information in relation to the product filings and registration is as on March 31, 2021
69
India
RoW
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