Hikal: Tailoring Custom Manufacturing Solutions
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Hikal: Tailoring Custom Manufacturing Solutions

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Manoj Mehrotra, President of Pharmaceutical Division, HikalManoj Mehrotra, President of Pharmaceutical Division
During the 1950s, with the mass availability of penicillin, the pharmaceutical industry was witness to the dramatic acceleration of scientific innovation and technical standardization. Today, the pharmaceutical industry is yet again at the crossroads of another revolution.

In the past 20 years, the industry has slowly shifted from the traditional blockbuster model of drug delivery to one that focused on more niche products and targeted delivery. The current market demand revolves around the more advanced synthesis and formulation expertise to develop cost-effective, efficient, and sophisticated medicines. Subsequently, this paradigm shift has also led to significant transformations of pharmaceutical contract development and manufacturing organizations (CDMOs) in the drug discovery and delivery supply chain. The modern CDMOs are now expected to bring together a more comprehensive and profound knowledge of drug development to accelerate the successful development and commercialization of contemporary candidate therapies. Enter Hikal, an Indian CDMO that offers development services starting from preclinical and going up to commercial manufacturing of early-stage intermediates, key starting materials, intermediates, and APIs.

Founded by Mr. Jai Hiremath in 1988, Hikal started as a fine chemical manufacturer focused on intermediates and key starting materials for global agrochemical companies and quickly carved a niche out for itself in the specialty chemicals and life sciences industry. And by 2001, Hikal ventured into the pharmaceutical industry and established a hybrid business model of contract development and manufacturing services and a portfolio of generic APIs to support lifecycle management by innovator companies.

The company today has emerged as a reliable partner of the global life sciences industry as a manufacturer and supplier of active ingredients, intermediates, and biocides. Hikal specializes in scaling up enzymatic processes and is now investing in setting up a lab for demonstrating continuous manufacturing for its customers. To this end, Hikal applies a broad toolbox of chemical reactions at the industrial scale, such as energetic chemistry, chiral chemistry, biocatalysis.

Our goal is to become the best in the pharmaceutical chemical CDMO space, and we are focused on achieving that


The company has also invested in solid-state chemistry using innovative analytical and manufacturing technology. Presently, Hikal has a few industrial processes running in the continuous mode, most notably being a liquid-liquid extractor for a commercial API. At the same time,the company has a proprietary project management tool, which helps in monitoring and reporting of customer projects on a real-time basis.“Our goal is to become the best in the pharmaceutical chemical CDMO space, and we are focused on achieving that,” highlights ManojMehrotra, president of the pharmaceutical division at Hikal.

To that end, Hikal’s Pharmaceutical business has set up three manufacturing sites and a research facility across India. Two of these three manufacturing sites are USFDA, EU GMP, and PMDA approved, and the third manufacturing site is expected to get similar approvals in 2021. Especially with USFDA, Hikal has an exemplary track record in terms of regulatory compliance to ensure its capability in minimizing the risk for its customers. And such capability has made Hikal a favorite among several of the top 20 multinational pharmaceutical companies and some of the leading generic companies globally. Mehrotra believes it is the speed and flexibility of their offerings that have helped them meet the expectations of such heavyweight clients.

To bolster his claim, Mehrotra cites one recent client engagement of Hikal. The client approached Hikal to quickly develop and supply an early stage starting material as the approved supplier of the client failed to fulfill the need. With the Hikal team promptly replicating the process for further optimization and scaling up, the partnership led to massive success for the client. Further, Hikal also took the proactive initiative of mitigating any supply chain risk for the clients by finding out India-based raw material suppliers. “We understand our customer's business perspective and continuously strive to provide a better experience to surpass the expectations of the people with whom we work,” adds Mehrotra.

With such success stories under its belt, Hikal is now in the midst of a significant investment program and has committed $50 million for the period 2019-21 on capacity expansion through new technologies and sustainability. For this expansion, Hikal has already obtained all the necessary environmental and statutory permissions and is in discussion with various innovator companies to contract out this capacity. Hikal is also focusing on building new capabilities in continuous manufacturing/flow chemistry. “Our customers are looking forward to setting up a lab-scale facility that will be very useful to try out new manufacturing concepts,” concludes Mehrotra.
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Company
Hikal

Headquarters
Mumbai, India

Management
Manoj Mehrotra, President of Pharmaceutical Division

Description
An Indian CDMO that offers development services starting from preclinical and going up to commercial manufacturing of early-stage intermediates, key starting materials, intermediates, and APIs. The company today has emerged as a reliable partner of the global life sciences industry as a manufacturer and supplier of active ingredients, intermediates, and biocides. Hikal specializes in scaling up enzymatic processes and is now investing in setting up a lab for demonstrating continuous manufacturing for its customers. To this end, Hikal applies a broad toolbox of chemical reactions at the industrial scale, such as energetic chemistry, chiral chemistry, biocatalysis. The company, moreover, has invested in solid-state chemistry using innovative analytical and manufacturing technology

Hikal