"Sadhana Nitro Granted Environmental Clearance for Paracetamol Ingredient Production"

In a significant development, Sadhana Nitro Chem Ltd has obtained environmental regulatory clearance to produce pAP (Para Aminophenol), a crucial ingredient used in the manufacturing of paracetamol, from Nitrobenzene. This milestone positions Sadhana Nitro as one of only two global companies engaged in the production of this essential pharmaceutical component. The announcement comes as a promising step towards ensuring a consistent supply of high-quality pAP, free from impurities, within India.

Abhishek Javeri, Managing Director of Sadhana Nitro Chem, expressed the company's enthusiasm regarding this achievement and its potential impact on the pharmaceutical industry. The other company involved in the production of this drug intermediate is the multinational Mallinckrodt Pharmaceuticals.

Javeri highlighted that approximately 80% of pAP is currently sourced from China, which has raised concerns within the industry regarding dependence and price fluctuations. He noted that over the past two years, the price of this raw material has oscillated between Rs 350 per kilo to Rs 700 per kilo. The increased local production of pAP is expected to contribute to price stability.

This venture marks a significant expansion for the Rs 147-crore specialty chemicals company into the pharmaceutical sector. The company was awarded a contract under the Indian government's Production-Linked Incentive (PLI) scheme to produce 36,000 tonnes of pAP in 2021.

Recently, the company received approval from the Maharashtra Pollution Control Board to manufacture pAP using Nitrobenzene, a method with substantial environmental benefits. In contrast to the traditional method involving Para Nitro Chloro Benzene (PNCB), the Nitrobenzene approach aligns with green chemistry principles and generates zero effluent. The PNCB process results in the production of various chlorine-based contaminants, including Para Chloro Aniline (PCA), a substance subject to increasing restrictions due to its harmful effects. In contrast, the Nitrobenzene method avoids the use of chlorine-based ingredients, resulting in a product free from PCA and other impurities.

Although the initial production projection aimed for March 2022, unforeseen regulatory constraints led to an initial delay in the project's timeline.

Globally, there is a growing demand for pAP that is free of chlorine impurities. The worldwide requirement is estimated to be between 1.60 to 2 lakh tonnes annually, with India importing approximately 50,000 tonnes. Prices for pAP tend to fluctuate in response to pollution concerns and geopolitical tensions.

Currently, Sadhana Nitro has a production capacity of over 3,000 tonnes, and the company is planning to further scale up its operations to capitalize on the global opportunity. When questioned about why other companies had not adopted similar cleaner technologies, Javeri explained that it required high-quality nitrobenzene, which the company has been producing since 1975, and that it involves a more complex chemistry.

HBL