The Indian Active Pharmaceutical Ingredient (API) manufacturers depending on Chinese imports of penultimate intermediates are finding it difficult to source raw material following the closure of major such manufacturing facilities in China. This has severally affected domestic producers of Ciprofloxacin and its prices are now ruling very high in the domestic market.

The price of Ciprofloxacin, a much sought-after antibiotic, has increased to Rs 1800 per kg now in the Indian market from the Rs 850 per kg during February this year. The major Indian API manufacturers of Ciprofloxacin are Dr Reddy’s Labs, Aarti Drugs, Tasc Pharma, Hiren Orgochem etc. Acetophenone is the key raw material used in the manufacture of ciprofloxacin and DCFB (Di Chloro Fluorobenzine) is the penultimate stage of acetophenone.

Out of the six principal manufacturers of DCFB in the world, four are in China and two in India—the Mumbai-based Aarti Industries and Anu’s Lab. The Chinese Government recently decided to regulate firms failing to comply with their stringent pollution control norms and as a result three of these manufacturing units were closed down.

Dr Sanjay M Sanghavi, president of The Chemist and Druggists' Association, Mumbai, an association of bulk drug and medicine dealers, said unless the Indian API manufacturers explore other options to source the raw material, the very survival of such units would be in trouble.

He said another API having the same problem is erythromycin, with penultimate intermediate, tioc. It is used to make APIs like erythromycin base, erythromycin estolate, erythromycin sterate, Azithromycin and Roxithromycin. The price of tioc, which was at $ 44/kg, has increased to $ 56/kg. The prices of levofloxacin and gatifloxacin were also increased to $82/kg and $78/g from $45 /kg and $42/kg respectively. The price of another API needed for the manufacturing of antibiotic Doxycycline has also increased from $31/kg to $43.5/kg. The price of oxytetracycline Hcl has also raised to $12/kg from $8.5/kg. However, the closure of Chinese penultimate intermediate companies is not going to much impact the Indian industry as India have adequate production of these APIs. Sources said a Chinese company situated at Xinchang country, which is one of the biggest manufacturers of levofloxacin, was closed down for dumping contaminated waste to the nearby river, following agitation by social activists.

The global demand for ciprofloxacin is at least 500 MT per month (6000MT per annum), with India and China being the biggest consumers accounting for almost 70 per cent of the total global demand. The average domestic demand for ciprofloxacin is estimated at 120 MT per month and approximately 250 MT per month in China.

Satish Nachane, managing director, Aarti Drugs said the prices of Ciprofoxacin in the Indian market might increase marginally in future. “With the DPCO price threshold for Ciprofloxacin pegged at Rs 4150 per kg, it provides ample room for Ciprofloxacin prices to increase from its erstwhile price of Rs 850 per kg to the current levels of Rs 1800 per kg in June, the price has almost doubled and expected to further increase anywhere in the range of Rs 2000 per kg to Rs 4000 per kg over the next one year,” noted Satish Nachane.