Sadhana Nitro receives green nod for manufacture of ingredient for paracetamol 

A recent environmental regulatory approval has made Sadhana Nitro Chem Ltd one of only two companies globally making an ingredient that goes into production of paracetamol - pAP ( Para Aminophenol) - from Nitrobenzene, the company said.

The development will assure high-quality indigenous supply of pAP that is free of impurities, Managing Director, Abhishek Javeri, told businessline. The other company that makes the drug intermediate is multinational Mallinckrodt Pharmaceuticals.

About 80 per cent of pAP is sourced from China, said Javeri, pointing to industry concerns on dependence and price fluctuations. In the last two years, the price of this raw material has fluctuated between Rs 350 per kilo to Rs 700 per kilo, he said, indicating that higher local production could help stabilise prices. 

This is the Rs 147-crore speciality chemicals company’s largest foray into pharmaceuticals. It was awarded a contract under the Centre’s PLI scheme to make 36,000 tonnes of pAP (2021).

Recently, the 50-year-old company got the Maharashtra Pollution Control Board’s approval to make the product. “Producing pAP from Nitrobenzene, as against its manufacture from Para Nitro Chloro Benzene (PNCB), offers significant benefits.

The PNCB method is marked by substantial effluent production, while the Nitrobenzene approach aligns with green chemistry principles, generating zero effluent. Notably, the PNCB process results in various chlorine-based contaminants, notably Para Chloro Aniline (PCA), a substance facing increasing restrictions due to its detrimental effects. In contrast, the Nitrobenzene method avoids use of any chlorine-based ingredients, ensuring a product free from PCA and other harmful impurities,” the company said in a filing to the stock exchange. The company’s initial projection was to start production by March 2022, “but unforeseen regulatory constraints posed an initial delay,” it said.

Globally, there is a growing need for pAP that is free of chlorine impurities, he said. The global requirement is estimated at between 1.60 to 2 lakh tonnes annually, he said, while India imports about 50,000 tonnes. And prices fluctuate when there are pollution concerns or geo-political tensions, Javeri said.

With a capacity of over 3,000 tonnes currently, the company is planning to scale up to tap the global opportunity as well. Responding to why others were not adopting similar cleaner technologies, he said it required high quality nitrobenzene, which they had been making since 1975, and it involved a more difficult chemistry, he added.

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