Pharmaceutical companies observe the growing sterile generics giant-Gland Pharma, India

Recently, a second major outbreak occurred in India, and India has fallen into a state of anxiety
.

When we set our sights on India, the most important thing that cannot be ignored is the pharmaceutical industry in which they continue to compete with China

Today, I would like to introduce to you a representative Indian pharmaceutical company—Gland Pharma, the sterile generics giant
.

Gland Pharma was established in Hyderabad, India in 1978.
It is a leading international company dedicated to generic injections in India
.

The company has R&D and production capabilities for original research drugs and preparations.

Figure 1 FY20 company revenue in various regions

Gland Pharma is the first injectable drug company approved by the US FDA in India.
The company has a variety of sterile injectables, including oncology drugs and ophthalmic drugs
.

At the same time, Gland Pharm is also gradually focusing on high-value generic drugs, such as complex molecules, first-to-file products, and 505(b)(2) applications for new drugs

According to Gland Pharm's 2020 annual report, the global pharmaceutical preparation market reached US$1.
096 trillion in 2019, of which oral solid preparations are the largest form of preparation.
The total market in 2019 reached US$490 billion, a compound annual growth from 2014 to 2019.
The rate is about 3.
5%; however, the market share of oral solid preparations has dropped from 50% in 2014 to 45% in 2019
.

Injection is the second largest dosage form.

Figure 2 Analysis chart of the global pharmaceutical preparation market

       In the international pharmaceutical market, the US pharmaceutical market has a greater influence due to strict supervision and high market value
.

According to the 2020 annual report of India's Gland Pharm, injection products account for a large proportion of American medicine, accounting for about 46% of the total market

Figure 3 Analysis of the U.
S.
pharmaceutical preparation market

       It can be seen that, due to the following factors, the share of injection products in the European and American regulated markets is gradually increasing :

       •Compared with other dosage forms, injections take effect quickly and have higher bioavailability

       •The way of administration can be accurately positioned

       • The development of pen-type syringes and auto-injectors has improved the convenience of patients

       •Added many new drugs that are not easily soluble in water and/or very low permeability after oral administration, so that they can be fully absorbed in the gastrointestinal tract

       • The rapid growth of biologics

       In addition, sterile drugs are high-risk products and are also strictly regulated products in the European and American pharmaceutical markets
.

Building and passing European and American GMP certification is an arduous task for aseptic pharmaceutical companies

       In 2017, Fosun Pharma (through a holding subsidiary) acquired approximately 74% of Gland Pharma's equity for US$1.
09 billion (approximately RMB 7.
2 billion), setting a record for the largest amount of Chinese investment in India
.

In November 2020, Gland Pharma was listed on the Bombay Stock Exchange and the Indian Stock Exchange, raising approximately Rs 64.

       At present, Gland Pharma in India has four preparation production bases, including 22 preparation production lines and 3 API production bases (Dundigal HyderabadSEZ, VisakhapatnamJNPC, Visakhapatnam)
.

The four preparation production bases have been certified or approved by many national regulatory agencies such as the US FDA, the UK MHRA, Australia TGA, Germany BGV, South Africa MCC, WHO, EU, Health Canada, and Brazil ANVISA

                                    

                              

Figure 4 Four preparation production bases

       As of March 31, 2020, Gland Pharma and its partners have completed 265 ANDA applications in the United States, 204 have been approved, and 61 are pending approval
.
The 265 ANDA declarations include 189 sterile injections, 50 anti-tumor drugs and 26 ophthalmology-related products
.
There are 100 of its own products belonging to Gland Pharma, of which 63 ANDA applications have been approved, and 37 are yet to be approved
.

       to sum up

       According to the above summary information and combing, it can be seen that through years of struggle in the European and American markets, India’s Gland Pharma has built a solid sterile drug production system and R&D reporting capabilities; after being acquired by China’s Fosun Pharmaceutical Group, it began to cooperate with each other.
Fosun Pharma's domestic branches have carried out coordinated operations and have begun to gradually deploy the domestic pharmaceutical market
.
Gland Pharam's own technical advantages, coupled with Fosun Pharma's influence and experience in the domestic pharmaceutical market, will make the cooperation between the two parties have a multiplier effect
.

       Reference materials:

       1-Gland Pharma official website

       2-Gland Pharma's 2019-2020 Annual Report

       3- Fosun Pharma official website data

       4-NMPA official website data