Gland B2B Business Model and Growth Strategy
24
Consistent Regulatory Compliance Track Record
Highlights
H
No warning letters
from USFDA (whether
as a result of facility
inspection or otherwise)
since inception of each
facility
All facilities Certified
GMP compliant by
USFDA, and certain
facilities by MHRA (UK),
ANVISA (Brazil), AGES
(Austria), TGA
(Australia) and BGV
Hamburg (Germany)
WHO GMP
certifications from the
Drugs Control
Administration
(Governments of
Telangana and Andhra
Pradesh, India) (DCA)
Focus on Quality Control
ISO certifications as
of March 31, 2021 (1)
eiie
1,191
fulltime employees in
Quality Control and
Quality Assurance (2)
30.07%
of the workforce in
Quality Control and
Quality Assurance (2)
35+
audits on average
per year, including
customer audit and
regulatory agency
audit
Quality Standards throughout the business units
Quality
Improvement
Laboratory Information
Management System
software for quality
control at all
manufacturing locations
and facilities
Corporate Quality
Establishment
Corporate reporting
structure for
identifying and
developing standard
operating procedures
Quality Audits
Conduct internal audits
across all facilities on a
quarterly basis
Note: (1) 3 ISO certifications as of March 31, 2021 for quality management, environment management and occupational health and safety management systems applicable to design, development and production
of pharmaceuticals and contract manufacture of small volume parenterals. (2) As of March 31, 2021
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