Express Pharma

“We plan to set up our first international manufacturing facility in US”

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Ideal Cures, mumbai-based manufacturer and exporter of pharma excipients and coating solutions has grown from strength to strength since its inception. It is now fortifying its global presence by setting up its first international manufacturing facility in the US.  Suresh Pareek, Managing Director, Ideal Cures divulges the company’s growth plans with Usha Sharma

The industry is looking for tailor-made solutions and products, so how do you handle such requirements?

Outsourcing is here to stay. Various branches of the industry have asked for outsourcing or tailor made solutions which led to establishment of BPO, call centers, property management services, house-keeping, and maintenance services. The reason for this is that it allows the company to maintain its competitiveness by focusing on their core business and outsource certain operations that are complex to handle. As the pharma industry grew it also looked at outsourcing certain operations so that they could focus on their core strength of manufacturing and R&D and also look at more complex formulations. In this process, pharma industry always looks for small scale and medium scale enterprises to provide them with tailor made solutions. We at Ideal Cures, decided to provide specialised solutions in excipients by focusing on products relating to film coating and drug delivery. We provide these solutions by constantly communicating with the industry professionals at various levels, through various industry forums and round table discussions. Our approach has always been to be able to add value by offering to be a dependable solution provider to the industry. We provide products which save time that are environment friendly and cost efficient. Best example of this is our product INSTACOAT 4g where we provided high productivity coatings products which saved 50-60 percent time and energy thereby reducing carbon emissions.

Recently, the company has launched Instacoat QD and Instacoat T2F, what have been the industry responses to these products?

We launched two new products at the 2nd FDD Conclave held in June 2018, at Hyderabad and the response for both the products at the conclave itself was overwhelming. More than hundred customers have shown interest for both these products and are interacting and working on solutions that these products will provide. INSTACOAT QD is quick disintegrating films which release contents of the tablet in 15-20 secs. The products are designed to provide a remarkable reduction in coating time and energy. INSTACOAT T2f  is another product specifically designed to meet the restrictions in regulated markets. These products are completely free of talc and TiO 2 and have already started receiving good response from customers in Europe and Americas.

What all products you offer to the Indian as well as international market?

We offer wide INSTACOAT range of film coating materials for both Indian and international market including immediate release coatings, quick dissolving coatings -INSTACOAT QD, moisture barrier coatings, high productivity coatings, enteric coatings for target delivery and easy solubility, neutral spheres for drug delivery -ESPHERES, cooling compounds for taste masking and enhancing palatability- ECOCOOL, sugar coatings- INSTACOAT SFC, polymers –ECOPOL , flavored, natural color coatings, and Coatings free of Talc and TiO2 of INSTACOAT T2f.

The company has established its presence in the Indian market, how do you plan to expand your international business?

Ideal Cures has had a decade of continuous expansion right from our first office in Milan, Italy in 2009, followed by an application lab in Turkey and Israel in 2013, office in Barcelona, Spain in 2015, and then US in 2016. Simultaneously, we have also expanded our list of agents and distributors in over 30 countries. And now Ideal Cures plans to set up its first international manufacturing facility in US – All these years we have serviced our clients through manufacturing facilities in India. We have not done any manufacturing outside India. The primary reason of opening of the US office two years back was to eventually set up a manufacturing facility. We have been actively looking for a good manufacturing location in the US and have now zeroed on the eastern coast to set up our first international manufacturing facility. We are excited. We have estimated a $7.5.million investment and expect the facility to go on commercial manufacturing in April 2020. We are also is in the process of expanding our office by recruiting more people in the US. Our main focus for the US facility would be to serve our existing customers in US, target new customers and offer them value added services and support them in their endeavor to increase production and reduce cost.

Did the industry get the clear definition of novel inactive ingredients excipients from the US FDA?

Novel excipient can be a material which has not been used till date for the products meant for human consumption and for this purpose the guidelines for clinical, safety and toxicity are available from FDA. Another way of novelty is to present a formulation using approved excipients, where the IID limits of the components can be considered for support. Yes, the clarity prevails for the Novel inactive ingredients as per US FDA norms. Though it looks like a NCE if the novel inactive ingredient needs to be approved due to complexities and detail study involved.

USP-NF Excipient Biological Safety Evaluation Guidelines <1074> provides guidance on conducting a safety assessment of a novel excipient. In the US, the FDA has also issued guidance on non-clinical studies for new excipients.

Tell us about the complexities and challenges associated with the US FDA Inactive Ingredient Database (IID)

I personally feel the guidance from IID data is helpful to select and quantify the materials in our formulations. However, there is some complexity, if the formulator is also using the same components in the product then the control on the quantity may not be possible and a conflict may arise. Additionally the database gives multiple products with varying quantities of the same ingredients and the value may vary many folds (from 2 to 200 mg). In a situation like this, it may be prudent to specify the maximum permissible usage for different routes in the quarterly updates.

Why IPEC disagrees with the FDA’s claim on the use of excipients that does not have precedence in the same route of delivery should always be viewed as high risk and subject to ANDA refusal?

US FDA considers the novel excipients as good as a NCE, a very elaborate and costly study programme is defined to be carried out. The material gets the entry into IIG database depending upon its use in a product as ANDA. There have been moves by IPEC and independent US agencies to evolve the wayout, whereas the FDA adopts ICH standards and guidelines for the detailed studies. Partly the high risk part as envisaged by US FDA looks logical if the route of delivery is different especially parenteral and nasal routes.

Give us a brief update on the company’s corporate plans for next financial year

Ideal Cures has always taken an initiative to cater to formulators’ specific needs whether it is related to film coating or specialty excipients. Next financial year will mostly be devoted to setup of the manufacturing unit in US and also in development of new products which will meet the requirement of the US market for pharma, nutra and OTC products. This we will achieve by working closely with the R&D companies in US. Another focus of the company will be to provide faster product deliveries to the customers in North-East India through our Sikkim plant.

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