Gland B2B Business Model and Growth Strategy
Business Overview (Cont'd)
17
Extensive Portfolio of Complex Products
Internal R&D & Regulatory Capabilities
Present in sterile injectables, oncology and ophthalmics, and focus
on complex injectables, NCE-1s, First-to-File products and
505(b)(2) filings
•
Delivery Systems:
Liquid vials
Lyophilized vials
•
Ampoules
Bags
•
Pre-filled syringes
•
Drops
Centralized R&D Laboratory located at Dundigal, Hyderabad
facility, with supporting personnel at each manufacturing facility
~268 personnel team including PhDs, pharmacy post
graduates and chemists
Plan to set up a new R&D building at Pashamylaram,
Hyderabad
R&D expertise supports regulatory filings globally
°
Anti-diabetic
•
Anti-infectives
Anti-malarials
Therapeutic Areas:
•
Neurological and Central
Nervous System
Ophthalmics and Otologicals
Pain, neuro-muscular
analgesics
Anti-neoplastics
(Oncology)
blocking agents
•
0
Blood-related
Respiratory
•
Vitamins, minerals &
•
Cardiac
nutrients
Gastro-intestinal
•
Hormones
Note: (1) As of March 31, 2021; refer to ANDA filings by Gland Pharma, along with partners.
•
.
Regulatory Track Record
284 ANDA Filings in US - 234 approved; 50 pending (1)
Of 284, 114 owned by Gland Pharma out of which
84 are approved and 30 are pending for approval
204 for sterile injectables, 53 for oncology and 27
for ophthalmics related products
1,501 product registrations globally, of which 389 in
United States, Europe, Canada and Australia, 69 in
India and 1043 in Rest of the world (1)
GLANDView entire presentation