Axxelent Pharma Science Pvt Ltd

Background

Axxelent Pharma Science Pvt Ltd, headquartered in Chennai, India, is a research and service-driven pharmaceutical company specializing in contract development and manufacturing. The company focuses on oral solid dosages, injectables, ophthalmic products, oral liquids, and topical formulations. Axxelent's mission is to develop and manufacture products that comply with regulatory requirements, aiming to be the preferred partner in contract development and manufacturing by offering capabilities that add value to customers and stakeholders.

Key Strategic Focus

Axxelent's strategic focus encompasses:

Contract Development and Manufacturing (CDMO): Providing end-to-end solutions from product development to commercial manufacturing across various dosage forms, including oral solids, injectables, ophthalmic products, oral liquids, and topicals.

Regulatory Compliance: Ensuring adherence to international regulatory standards, including those set by the US FDA, EU-GMP, UK MHRA, Health Canada, TGA Australia, and ANVISA Brazil.

Technological Innovation: Developing proprietary technologies such as AxxSmart (Gastrointestinal Tract site-specific delivery), AxxMUPS (Immediate and Modified Release technologies), AxxEye (Preservative-free ophthalmic drops), AxxInnova (Alternative oral solid dosage forms), and AxxLyo (Lyophilized injectables).

Global Market Expansion: Targeting regulated markets in North America, Europe, and Asia through strategic partnerships and collaborations.

Financials and Funding

As of the financial year ending March 31, 2022:

Revenue: Operating revenue between INR 1 crore and 100 crore.

Net Worth: Increased by 277.07%.

EBITDA: Decreased by 134.55%.

Total Assets: Increased by 336.70%.

Liabilities: Increased by 2,323.15%.

The company has secured funding through financial instruments, including a charge of INR 175.71 crore with HDFC Bank Limited on November 29, 2022.

Pipeline Development

Axxelent's pipeline includes:

Oral Solid Dosage Forms: Tablets (Immediate Release, Modified Release, Bi-Layer), Hard Gel Capsules (Powder and Pellets), and Dried Granules.

Oral Liquids and Semi-Solids: Solutions, Syrups, Suspensions, Ointments, Creams, and Gels.

Injectables: Liquid and Lyophilized Injections, Prefilled Syringes, and Ampoules.

Ophthalmic Products: Preservative-free formulations.

The company has received Health Canada cGMP compliance certification for its non-sterile facility in Sri City SEZ, Andhra Pradesh, following an inspection in September 2024.

Technological Platform and Innovation

Axxelent's proprietary technologies include:

AxxSmart: Gastrointestinal Tract site-specific delivery.

AxxMUPS: Immediate and Modified Release technologies.

AxxEye: Preservative-free ophthalmic drops.

AxxInnova: Alternative oral solid dosage forms.

AxxLyo: Lyophilized injectables.

Leadership Team

Dr. S. Devendra: Founder.

Jitesh Devendra: Co-Founder & CEO. Over 21 years of experience in pharmaceuticals, including API and formulations, with leadership roles in B2B and B2C businesses.

Hariharan S: Director. Over 35 years of experience in corporate finance, mergers and acquisitions, and international expansion.

Dr. Sampathkumar Devarajan: Executive Director & Chief Scientific Officer. Over 24 years of product development experience, with expertise in regulatory affairs and clinical trials.

Sreenivasa Reddy B: Executive Director & Chief Operating Officer. Over 27 years of experience in pharmaceutical manufacturing, quality assurance, and plant operations.

Leadership Changes

No recent significant leadership changes have been reported.

Competitor Profile

Market Insights and Dynamics

The Indian pharmaceutical industry ranks third globally in volume and fourteenth in value, contributing approximately 20% of generic medicines sold worldwide. The industry is characterized by a large number of companies and manufacturing units, positioning India as a reliable partner in the global pharmaceutical market.

Competitor Analysis

Key competitors in the contract development and manufacturing sector include:

Sun Pharmaceutical Industries: A leading global specialty generic pharmaceutical company.

Dr. Reddy's Laboratories: Engages in the manufacture and marketing of a wide range of pharmaceuticals.

Cipla: Focuses on developing medicines to treat respiratory, cardiovascular, and other conditions.

Biocon Limited: Specializes in biopharmaceuticals and generic formulations.

Strategic Collaborations and Partnerships

In May 2024, Axxelent partnered with Focus Care Pharmaceuticals, a Netherlands-based generic pharmaceutical company, to develop and market generic products for the Dutch and broader European markets.

Operational Insights

Axxelent's manufacturing facility in Sri City SEZ, Andhra Pradesh, offers advantages such as duty-free importation of raw materials. The facility is designed to meet regulations of CDSCO, US FDA, UK MHRA, AU TGA, PMDA, WHO, and other regulatory agencies.

Strategic Opportunities and Future Directions

Axxelent plans to:

Expand Manufacturing Capabilities: Initiate Phase-2 operations for sterile products, including injectables and ophthalmic formulations.

Enhance Technological Platforms: Develop in-house patented technologies for differentiated products.

Strengthen Regulatory Compliance: Obtain accreditations from various regulatory agencies, including India GMP, EU GMP, UK MHRA, Health Canada, TGA Australia, and US FDA.