The Japanese pharmaceutical company, Nippon Zoki Pharmaceutical co Ltd., is looking for tie-ups with Indian pharmaceutical companies to outsource APIs and formulations to Japan. The talks with some of the companies have started and a deal could be signed soon, according to company officials.

Speaking to Pharmabiz, Nakamura Kyohei, Manager, Overseas Business, Nippon Zoki Pharmaceutical said, "Our plan is to manufacture and market the formulations by receiving APIs from Indian bulk drug manufacturers. We are seeking APIs mainly, in the segments of anti-pain and anti-allergic."

"We are looking for the bulk drug manufacturing companies having GMP facilities and better technologies. If we buy out the APIs, the Indian company concerned itself will have to file the Drug Master File (DMF)," Akimoto Michio, general manager, Nippon Zoki said. However, he refused to divulge any financial details. "As the talks are on initial stages, we are unable to disclose any more details," he said.

Nippon Zoki Pharmaceutical Co., Ltd. was founded in 1939. The company and The Medical University of South Carolina (MUSC) had jointly established the Konishi-MUSC Institute for Inflammation Research at the MUSC campus in 1999. The focus of research is on diseases related to the kallikrein-kinin system and on Neurotropin, a drug developed by Nippon Zoki, and related substances. This institute serves as a research base for the company in the US.

Nippon Zoki's Institute of Bio-Active Sciences, established in 1983, conducts basic research on drug development with its main focus on the research of bioactive substances.

Mastigen-S Drink (oral solution containing iron, calcium, and Vitamins B2 and B6),
Mastigen-S tablet, Mastigen DrinkA, Pushban (a wound medication), Icetroche (non-sugar medicated pastille containing cetylpyridinium chloride) are Nippon Zoki's major OTC brands.

The $200-million Nippon Zoki Pharmaceutical is one among the Japanese companies that aim at India as a destination for outsourcing APIs and formulations. The leading companies from $65-billion Japanese market like Hyoshipara, Takeda, Mitsubishi Pharmaceuticals, Sumitomo, Sankyo, Teisho and Shinogi are learnt to be eyeing the Indian drugs industry to float business relations for joint research, business process and product outsourcing, and marketing alliances.

Eisai, one of the leading Japanese companies, had entered alliances with Wockhardt and GlaxoSmithKline Pharmaceuticals, India earlier. The company had signed a co-promotion agreement with GSK to market PARIT (rabeprazole sodium), Essai's original research medicine for gastric disorders. It has launched Aricep (donepezil hydrochloride) to treat Demetia (disorder related to memory) with Wockhardt Ltd. It is learnt that the company also has plans to introduce Mynol Zonegram, a medicine for muscle relaxation.
Eisai is the first Japanese pharmaceutical company having a subsidiary in India.

Another Japanese companies, Fujisawa Healthcare, and Tanabe Seiyaku had tied up with Elder Pharmaceuticals for two anti-hypertensive products imidapril (Tanabe) and nilvadipine (Fujisawa) in India. It is learnt that the companies has initiated in-licensing talks with Indian pharmaceutical majors like Lupin, Ranbaxy, Nicholas Piramal and Wockhardt.

Earlier, Pharmabiz had reported that Daiichi Pharmaceutical Co Ltd, the seventh largest Japanese pharmaceutical company with an annual global turnover of more than 323 billion Japanese yen is planning to set up its Indian subsidiary.

Nowadays, the positive changes in the stringent regulatory norms in Japan have made Japan an attractive market for Indian companies. Reliance Life Sciences' collaboration with Otsuka, as part of its genome research initiative to promote personalised medicine; Lupin's marketing tie-up with Kyowa Pharmaceuticals and Ranbaxy's joint venture with Nippon Chemiphar are the few examples.

However, the foreign companies who enter the Japanese market will have to meet Japanese pharmacopoeia requirements both for APIs as well as dosage forms. They will have to file fresh Drug Master Files (DMFs) and Abbreviated New Drug Applications (ANDAs) in Japan. Japan is the third largest market in the world after US and Europe in terms of per capita consumption of drugs.