GLAND

The company was incorporated as Gland Pharma Private Limited, a private limited company, at Hyderabad under the Companies Act, 1956 on March 20, 1978 and was granted the certificate of incorporation by the Registrar of Companies, Andhra Pradesh at Hyderabad. Subsequently, the name of the company was changed to Gland Pharma Limited pursuant to a special resolution passed by the shareholders of the Company on December 5, 1994, and a fresh certificate of incorporation dated April 25, 1995 was issued by the Registrar of Companies, Andhra Pradesh at Hyderabad consequent upon change of name and conversion into a public limited company under the Companies Act, 1956.

The company is one of the fastest growing generic injectables-focused companies by revenue in the United States from 2014 to 2019. It sells its products primarily under a business to business (B2B) model in many countries including the United States, Europe, Canada, Australia, India and the Rest of the world. It has a consistent compliance track record with a range of regulatory regimes across these markets. It also has an extensive track record in complex injectables development, manufacturing and marketing and a close understanding of the related sophisticated scientific, technical and regulatory processes. It was established in Hyderabad, India in 1978 and has expanded from liquid parenterals to cover other elements of the injectables value chain, including contract development, own development, dossier preparation and filing, technology transfer and manufacturing across a range of delivery systems. It has a professional management team and one of its Promoters, Shanghai Fosun Pharma, is a global pharmaceutical major.

Business area of company

The company is focused on meeting diverse injectables needs with a stable supply of affordable and high quality products. It has established a portfolio of injectable products across various therapeutic areas and delivery systems. It is present in sterile injectables, oncology and ophthalmics, and focus on complex injectables, NCE-1s, First-to-File products and 505(b)(2) filings. Its delivery systems include liquid vials, lyophilized vials, pre-filled syringes, ampoules, bags and drops. It is expanding its development and manufacturing capabilities in complex injectables such as peptides, long-acting injectables, suspensions and hormonal products as well as new delivery systems such as pens and cartridges.

Awards, accreditations and recognitions:

2014:

• Awarded the ‘Outstanding Exports Performance Award’ under the Regional (America and Oceania) category by Pharmaceuticals Export Promotion Council of India.
• Received the BS OHSAS 18001:2007 certifying the occupational health and safety management system of our manufacturing facility at Dundigal.
• Received ISO 14001:2015 certifying the environmental management system of company’s manufacturing facility at Dundigal.
• Received ISO 9001:2015 certifying the quality management system of manufacturing facility at Dundigal.

2016:

• Awarded the ‘Top Exporter/Importer’ by the Hyderabad Customs Commissionerate, Customs and Central Excise, Government of India.

2017:

• Awarded the ‘Excellence in Export Performance’ at the Federation of Telangana and Andhra Pradesh Chambers of Commerce and Industry instituted by Surana Group of Industries, Secunderabad.
• Awarded the ‘Outstanding Export Performance Award’ under Formulations Fast Growing -1 category by Pharmaceuticals Export Promotion Council of India.

2018:

• Awarded the ‘Top Exporter’ by the Hyderabad Customs, Customs and Central Excise, Government of India.
• Awarded the ‘Outstanding Export Performance Award’ under Formulations Silver Star category by Pharmaceuticals Export Promotion Council of India.

2019:

• Awarded the ‘Best Exporter’ by the Hyderabad Customs.
• Awarded the ‘Express Pharma Excellence Awards 2019’ under the turnover base Rs 500-2000 crore category organized by the Express Pharma and Optel Group.
• Awarded the ‘Telangana Best Employer Brand Award’ at the 14th Employer Branding Awards organised by the Employer Branding Institute, India.

Major events and milestones

• 1978: Incorporation of the Company by P.V.N. Raju.
• 2000: Set up the in-house R&D facility at Dundigal, Hyderabad.
• 2003: Received USFDA approval for the manufacturing facility at Dundigal.
• 2004 -2 005: Launch of Enoxaparin Sodium Injection (Cutenox) in India and Rest of the world markets.
• 2007: Capital infusion of approximately Rs 1,000 million into the Company pursuant to private equity investment aggregating to approximately Rs 1,200 million with EILSF Co-Invest I LLC.
• 2010: Launched Heparin Sodium Injection in the US.
• 2012: Received the ‘Certificate of GMP Compliance of a Manufacturer’ from BGV Hamburg (Germany) for manufacturing facility at Dundigal.
• 2014: Obtained USFDA approval for small volume parenteral manufacturing facility at Visakhapatnam.
• 2014: Commissioned the Pashamylaram Unit-II manufacturing facility.
• 2014: Received the ‘Certificate of GMP Compliance of a Manufacturer’ from MHRA (UK) for manufacturing facility at Dundigal.
• 2014: Capital infusion of $100 million into the Company pursuant to private equity investment aggregating to approximately $ 200 million with KKR Floorline Investment.
• 2016: Obtained USFDA approval for facilities at Jawaharlal Nehru Pharma City, Visakhapatnam.
• 2016: Obtained USFDA approval for manufacturing facility at Pashamylaram.
• 2016: Obtained USFDA approval for facility at the Visakhapatnam Special Economic Zone.
• 2017: Fosun Singapore acquired 74% stake in the Company.
• 2018: Received ANDA approval for Enoxaparin Sodium Injection USP for the US market.
• 2018: Received ANDA approval for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1%, our first Ophthalmic product approval.
• 2019: Filed Dexrazoxane for Injection, company’s first filing with the National Medical Products Administration, China, and received clinical waiver.