Many pharmaceutical companies are conducting extensive researches and are often credited for providing potential cures for lifesaving treatments. One such company is Arch Pharmalabs. It is one of the topmost pharmaceutical companies that is aligned across two business verticals-Products and Services. Its products business comprises manufacturing and sale of Active Pharmaceutical Ingredients and intermediates to innovator and generic pharmaceutical players in both domestic and international markets. To expand its horizons, the company has also evolved over the years and offers contract research and manufacturing services (CRAMS).
Ajit Kamath is the Executive Chairman and Managing Director of the company. He is involved in the planning and formulation of the entire business strategy and developing long-term business relationships for Arch Pharmalabs.
FOCUS ON QUALITY AND SAFETY
Arch Pharmalabs continuously focuses on improving its Quality Management Systems and maintaining full compliance with all applicable statutory and regulatory requirements with an aim to achieve total customer satisfaction. The company has assigned certain responsibilities to the Corporate Quality Assurance Department. Some key responsibilities include:
- Ensuring full compliance with cGMP, ICH Q7A, ISO, pharmacopoeial requirements that are clearly implemented by the staff of the company, and
- Establishing quality objectives and performance standards
CONTRACT RESEARCH AND MANUFACTURING SERVICES
Arch Pharmalabs provides many CRAMS such as route selection/ process development/ optimization, analytical development, stability studies, safety studies, scale-up to technology transfer / clinical-trial manufacturing to commercial manufacturing to suit US / EU regulatory requirements. The company handles and manages various complex reactions at different scales of operation, ranging from a few grams to several tonnes. By using a proprietary bio-catalytic/ enzymatic technology availed by the company, it has developed an innovative route for the manufacturing of key advanced intermediates.
The company currently captures values at 3 prominent parts of the CRAMS value chain through different initiatives:
- Pre-Commercial Work includes exclusive synthesis/custom work for innovators on NCE candidates.
- High-Value Technologies With Significant Entry Barriers includes manufacturing of technologically challenging products.
Commercial Manufacture Of On-Patent APIs And Intermediate includes partnering in drug development efforts through custom manufacturing of APIs and Intermediates and also participating in process research.
ENVIRONMENT, HEALTH & SAFETY
All the activities and services are carried out considering appropriate environmental, health, and safety risks. It works in accordance with the relevant legal requirements. It has incorporated certain EHS measures which include:
- Full-fledged effluent treatment plants on all facilities
- Solid Waste Management Systems
- Solvent Recycling
- Water Treatment Facilities
Arch Pharmalabs has also invested in reverse osmosis plants which is a proof of its commitment to exemplary EHS practices. Its treatment plants have both anaerobic and aerobic treatment facilities.
KEY TECHNOLOGIES OF THE COMPANY
Diversified Offering Portfolio
The company provides more than 120 products (over 65 APIs and over 55 Intermediates) across various therapeutic segments including side chains of Semi-Synthetic Isoxazole Penicillins under Antibiotics, Lipid-Lowering Agents, Oncology, Anti-Platelet Agents, Anti-Asthmatic, Anti-Retroviral, Decongestant, Anti-Herpes, Anti-Malarial, NSAIDs, Anti-Anginal segments. Over the years, it has also added services under CRAMS. Not only this, it has also increased its presence in therapeutic segments like Lipid-Lowering and Anti-Platelet Agents and has forayed into growth potential segments like Oncology and Controlled Substances.
R&D and Key Technology tie-ups
Over the years, the company has built itself in handling several complex reactions in a cost-effective manner ranging from multiple, multi-product facilities with capacities varying from gram to kilograms and multi tons. It has done technology agreements with many technology providers based in the US, UK, and EU. These technologies further help the company to work towards the implementation of green Chemistry initiatives which not only help in reducing the production costs but also improving the quality of the products.
Arch Pharmalabs has the best R&D capabilities for the identification and development of potential API and intermediate products and towards process development, analytical research, and clinical research. Its consistent focus on research and development has resulted in several patent applications with Indian, US, and European patent offices.
The company manufactures a variety of APIs and intermediates using a combination of processes. Its manufacturing infrastructure is very flexible that enables the company to expand its product portfolio and product mix in response to changes in customer demand and to serve customer requirements ranging from laboratory scale research to commercial production. Currently, it has 8 manufacturing facilities across India with reactor capacities of around 1200 KL.
Established in the year 1999, the company strives to maintain integrity during challenging situations. Its biggest growth is the result of being ready to face the toughest times and proudly emerging victorious. Arch Pharmalabs’ contribution to the pharmaceutical industry is phenomenal.