Nitin Lifescience: Manufacturing Highquality Injectables

Chetan Sobti, CEO, Nitin Lifescience

Chetan Sobti

CEO, Nitin Lifescience

The Indian CMO market is anticipated to register a double-digit growth in next few years. The rise in the demand for injectable drugs is predicted to drive this market growth. India offers a unique competitive advantage in the global pharmaceutical industry. Indian Pharma CMO market is witnessing a paradigm shift with companies now focusing on building a conducive environment for spurring domestic manufacturing and exports and seeking newer avenues for expansion - biologics, therapeutic drug development and digital tools. This is where Nitin Lifesciences/ Nichepharm- rapidly growing Indian pharmaceutical companies with a strong presence in injectable manufacturing comes into the picture.

Nitin Lifesciences/Nichepharm has always been quality conscious manufacturers and focus has always been adhering to zero defect products. With the company’s largest capacities in injectable space and economies of scale, it is able to pass on the competitive pricing advantage to its customers. In an exclusive interaction with India Pharma Outlook, Dr. Chetan Sobti, CEO of Nitin Lifesciences and Co-Founder/Director of Nichepharm shares his views on how the current market for Contract Manufacturing is evolving in India and how Nitin Lifesciences and Nichepharm with its strong presence in Injectable manufacturing meet the requirements of clients in this landscape.

How do you see the Pharmaceutical Contract Manufacturing Organization (CMO) Market evolving in India? What are the major factors that have been driving the market’s growth?
The Indian pharmaceutical industry ranks third worldwide for production by volume and caters to 20 percent of the global demand in the generic market in terms of volume. With a strong network of 3,000 drug companies and approximately 10,500 manufacturing units spread across the length and breadth of the country, India offers a unique competitive advantage in the global pharmaceutical industry. India has a superior edge over nations, such as Vietnam, China, and Ireland, due to resources including manpower, technically knowledgeable workforce, and WHO-GMP approved production premises and is expected to further strengthen its leadership position in the contract manufacturing space globally. Major factors contributing to the growth of the Indian pharmaceutical contract manufacturing market include increasing investments in the Indian pharmaceutical sector and government initiatives like the Make-in-India campaign, the PLI scheme to promote the pharmaceutical sector and the increasing trend of outsourcing of healthcare services.

How is Nitin Lifesciences/Nichepharm positioned in the Pharma contract manufacturing segment?
Nitin Lifesciences and Nichepharm Lifesciences as a group have been positioned among the leading contract manufacturers in the injectable space. With a combined capacity of over 1.5 Bn units per annum, Nitin and Nichepharm combined are catering to around 10% of total injectable production in India. With its distinctive capabilities in meeting customer expectations, manufacturing prowess and strong industry relationships, both the companies have stood out from the others and have been the most trusted CMO for many leading pharmaceutical majors.

What are the key checkpoints that your products pass through to ensure consistent quality?
Quality has been our core strength and we pay utmost focus on each step wherein all our systems act as filters at all levels to ensure that our products are of good quality. We have deployed various initiatives that strengthen our quality management systems embedding a culture of quality with-in the organization.

Our production lines at Nichepharm are all automated tunnel lines with o-RABS and have minimal human intervention. All lines have automated camera based visual inspection machines.

Moreover, the responsibility of QA and QC department people is clearly defined. The Organizational structure is such that technical, administrative and human factors affecting quality are controlled and reviewed by management. Emphasis is laid on basic quality aspects such as systematic sampling, testing, validation, monitoring and auditing facility, systems, equipments, instruments to ensure the quality of processes and products.

Shed light on the infrastructure of Nitin Lifesciences and Nichepharm. How have you leveraged technology in your overall operations?
We have evolved through our learnings and have implemented all our learnings in the infrastructure development. The facility at Nichepharm has one of the best infrastructures for an injectable facility in India complying to all international regulatory standards. The facilities have state-of-the-art modular aseptic processing technology, equipment and systems. All the lines and blocks are appropriately segregated to avoid any chance of mix-ups. The facilities are designed to have a linear and organized flow of personnel and material movement.

Some of salient infrastructural features of our sites are - Vapor compression distillers for WFI generation, automated loaders/unloaders for lyophilizers, manufacturing vessels equipped with low shear magnetic mixers, online statistical check weighing.

Going forward it is very important for all CDMOs like us to leverage the emerging technologies to transform and be in line with the international quality and standards. We have already initiated our efforts to implement track and trace systems for products meant for export markets. We aim to set up serialization infrastructure at our facilities across the entire value chain to prevent counterfeiting and have transparency.

Quality Has Been Our Core Strength And We Pay Utmost Focus On Each Step Wherein All Our Systems Act As Filters At All Levels To En- Sure That Our Products Are Of Good Quality

Chetan Sobti, CEO, Nitin Lifescience

Please elaborate what are the key points that differentiate your company from other players in this segment.
The key differentiator I believe is the personal commitment of the management. Even after 25 years, we are actively involved in all the processes and have set our internal checkpoints to evaluate the business from every perspective. Moreover, we pay equal attention to relationship building and all of our customers be it large MNC or a small Pharma company whosoever has associated with us has stayed with us for years. Other important aspect which differentiates us from others in the league is that we lay supreme importance on maintaining the highest standards of Environment, Health and Safety.

We follow a zero-tolerance policy for anything and everything which may compromise safety of our people and do any harm to the environment. We actively seek to minimize and manage the environmental impact of all our operations and offerings through responsible business practices.

Where do you see this market in the near future? What is the future roadmap for your Company?
The market for contract manufacturing is set to register growth in double digits. We have already geared up to embark on the next level journey with Nichepharm and will be targeting difficult to make products and stringent regulatory markets.

We have got good responses and feedback from customers for the Nichepharm facility. We wish to establish ourselves among the leading players in global CDMO space and go to company for injectable requirements across the globe.

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