China and India have long been trade partners until the issue of the silk route cropped up and disturbed the relationship. History states that bustling business activities prevailed between these two growing powers from the days of yore.
In the recent past the trade between the two countries have started flourishing particularly in the pharma industry. Exports and imports between these two countries particularly in the API segment is booming. And a few companies from India and a handful from the Southern part of India shine on the Chinese soil.
Orchid Pharmaceuticals from Chennai has carved a niche for itself in the API segment.
The strength of the company is mounting day by day and this can be substantiated by the fact that this year Orchid's betalactam active pharmaceutical ingredient (API) facility at Aurangabad got the Medicines and Healthcare products Regulatory Agency (MHRA) approval.
The MHRA approval is an important step in the overall regulatory road map for and marketing of the Orchid's key betalactam product, piperacillin - tazobactam in the lucrative European markets. It also signifies the first major international approval for the Aurangabad API manufacturing complex, which is slated to play a major role in diversification of the Orchid's product range in terms of niche, premium antibiotics and other pharmaceutical products.
Moreover Orchid's growth was reflected in financial year results. Its API (bulk) business generated sales of Rs 526.84 crore and formulations business registered an overall growth in sales at Rs 407.33 crore largely led by the sustained growth in the US generics business.
Commenting on the result, K Raghavendra Rao, managing director, Orchid Chemicals & Pharmaceuticals had stated that the company continued to derive an increasing share of business from the regulated markets and dosage forms, thus firmly moving up the pharmaceutical value chain further during the year under review.
More importantly, the last fiscal has been another landmark year in terms of international regulatory approvals with the UK MHRA approving the oral and sterile cephalosporin API and dosage form plants as well as the betalactam API and dosage form plants, paving the way for a multi-pronged foray into the European markets.
In addition, the betalactam API and non-penicillin, non-cephalosporin API plants have undergone US FDA inspections. These several approvals augur extremely well for the growth of the regulated market business in the future, Rao observed.
The company's cumulative DMF and ANDA filing count stood at 45 and 39 respectively. Of the DMFs filed, 26 are in the cephalosporin space, 17 in the non-penicillin, non-cephalosporin (NPNC) segment and 2 in the penicillin product area. Out of the 39 ANDAs filed, 27 correspond to cephalosporins, 10 to the NPNC products and 2 in the sterile penicillin area. Orchid has received total approvals for 18 of its ANDAs.
Orchid's name has been prominent not only in US and European markets, but also has started ringing in the competitive Chinese market. Eyeing the healthy Chinese market, Orchid entered into a manufacturing and marketing joint venture with the North China Pharmaceutical Corporation (NCPC), the largest pharmaceutical group in China.
China is now considered as one of the most competitive manufacturing bases in the world and is also a fast growing market for pharmaceuticals and the single largest market for Orchid's cephalosporin products. Given Orchid's efficacy in technology and manufacturing and NCPC's wide market presence in China, this venture (NCPC-Orchid) provides Orchid a strong presence in the Chinese market.
Established in July 1992 as a 100% Export Oriented Unit (EOU), Orchid commenced its operations in February 1994. The company achieved rapid growth to emerge as the eleventh largest company in the Indian pharmaceutical industry in a short span of eleven years of operations. It employs over 3000 people, of which over 600 are scientists, technologists and other professionals.
For catering to the needs of the API segments, Orchid has two manufacturing sites at Alathur, Chennai and Aurangabad. There are also three manufacturing sites for Dosage forms at Irungattukottai and Alathur, besides two R&D centres at Sholinganallur and Irungattukottai.
Orchid's facilities are state-of-the-art and have several international regulatory approvals, including the US FDA and UK MHRA. These API facilities are also ISO certified for their quality and environmental management systems. Orchid has a subsidiary in the US for Drug Discovery and a Joint Venture in China for manufacturing APIs.