Apologies for the delayed response. I have studied the USFDA DMF Filings. To the best of my knowledge, the only close competitor to Concord in India is Biocon. RPG Lifescience manufactures Tacrolimus but not in a big way. For every product of Concord, there are 2-3 Chinese manufacturers. The customers in this business are ANDA holders supplying to the US generic market. The negative of having Chinese competitors is that they are extremely aggressive when it comes to pricing and they have huge scale (which has led to death of many fermentation based API companies in India). The positive side is that a) Regulatory Compliance (with FDA norms) is the key when it comes to supplying to the US market. Historically, the Chinese players have had a poor track record in India (though the list of Chinese competitors does show the names of players like Scinopharm (who have been compliant). b) Chinese players have had relatively poor track record when it comes to OTIF (on time in full). If Concord can maintain a good compliance track record and keep on supplying reliably at the right time and cost, then Concord can keep on gaining share over time. The above points about characteristics of Chinese players is a more general trend. Specifics of current competitors of Concord is impossible to know.
Gujarat Themis Bio does not manufacture the products which Concord makes. Gujarat TB by far has only excelled at making two products a) Rifamycin and b) Lovastatin. This management has not shown much ambition.
The key risk in these products is someone coming up with a superior process leading to much lower cost vs Concord. By far, this risk has not played out imho.
Also, this a B2B Business. The new player needs to come up with a basket of products. Without the full basket, the new player will never have negotiating power with the customer.
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