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manufacturing CAPITAL

Home Corporate Overview

Adhering to world-class standards, our integrated manufacturing facilities enable us to produce affordable and superior quality medicines. As a customer-focused business, we are enhancing capacities and leveraging economies of scale to ensure access to critical medicines.

Finished Formulation Facilities

3

Hyderabad

1

Visakhapatnam

API Facilities

2

Hyderabad

2

Visakhapatnam

Business Overview

*Under Tech Transfer model, exhibit batches and stability studies are performed by Gland Pharma.

Our core strengths

State-of-the-art Facilities

Strong Quality Assurance & Quality Control

Economies of Scale

Vertically Integrated

Compliance Track Record

Diversified Product Portfolio

Finished Formulation Facilities

We have four finished formulation facilities, including two sterile injectables facilities, one dedicated Penems facility and one dedicated Oncology facility. Our manufacturing processes are designed to facilitate maximum production flexibility, while maintaining the highest standards of quality, consistently.

23

Production
Lines

767

Finished
Formulation Capacity

million units

Our production lines possess the flexibility to accommodate different product requirements without the need to install new production lines. This allows us to quickly adapt to changes in product specifications, market demand and production requirements. Our Facilities have a consistent track record of regulatory compliance and it enables us to mitigate exposure to regulatory risks. Through strategic efforts, we ensure regular supply of products and acquire approvals for manufacturing our key products.

API Facilities

Our ability to manufacture APIs enhances our vertical integration strategy, particularly for difficult to source APIs, giving us better control of the supply chain and enhanced cost efficiencies. We have several ANDAs which are vertically integrated, coupled with a substantial portion of our pipeline supported by our in-house APIs.

32

ANDAs
supported by in-house APIs

Location

Dundigal, Hyderabad, India

R&D pilot plant for development and lab scale manufacturing

Key Regulatory Approval

USFDA (US), MHRA (UK), ANVISA (Brazil), TGA (Australia), BGV Hamburg (Germany)

Location

Hyderabad, India

Biotech drug substance facility for vaccine and Bio-similars

Location

Visakhapatnam, India

CAPACITY

3,000 kg/year

Key Regulatory Approval

USFDA (US), ANVISA (Brazil)

Location

Visakhapatnam, India

CAPACITY

8,000 kg/year

Key Regulatory Approval

USFDA (US), DMA (Denmark)

Quality First

We place utmost importance on maintaining the standard of our products. In addition to quality assurance and quality control at our manufacturing facilities, we have established a three-pronged quality standard plan.

Quality Improvement

We have implemented multiple automation systems for quality control at all our manufacturing locations. We continually strive to improve our quality standards through the implementation of site specific quality teams that enable information sharing across sites and from external sources. Across the organisation, we monitor key quality performance indicators, act on market complaints, out-of-specification results, deviations and batch rejections.

Corporate Quality Establishment

We have a corporate reporting structure, with specific roles and responsibilities to identify and develop our standard operating procedures, create harmony among organisational procedures and implement action plans. We also aim to concentrate on regulatory findings during inspections and strengthen procedures and documentation.

Internal Quality Audits

We conduct quarterly internal audits across all our manufacturing facilities, in addition to the regular customer audit and regulatory agency audits. These audits thoroughly scrutinise our compliance with quality systems and procedures. We also work under the supervision and guidance of external consultants, across our facilities.

As on March 31, 2021

1,191

full-time employees in Quality Assurance and Quality Control

Way Ahead

~ ₹ 7,700 million

Planned capex in FY 2021-22 and FY 2022-23

Ongoing Capacity Expansion

Adding new lines at our Pashamylaram facility

Capacity expansion of Visakhapatnam API plant with the addition of new block

Acquisition and expansion of Biotech Drug Substance plant

Inorganic Growth Strategies

1

Acquire niche technologies

2

Acquire assets providing access to new geographies

3

Investments in assets that strengthen backward integration

4

Acquire assets providing new manufacturing capabilities