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Ahmadabad based injectables player, Claris Life sciences has appointed an external consultant to resolve the issue with the US Food and Drug Administration (USFDA) regarding exports of its products to US. The USFDA had slapped a notice in November last year that barred the company from exporting products manufactured at its Bavla facility to US. FDA investigators had found violations in the current good manufacturing practices (CGMP) regulations for finished products or pharmaceutical formulations at the Bavla site, and hence imposed a ban on exports.
Claris has been maintaining regular communication with the US regulator ever since, and has also roped in an external consultant to work on quality control measures. The FDA notice has been a setback to the company as a significant portion of its annual revenues come from exports. US accounts for nearly 13-14 per cent of its total exports. It might be noted here that during April-May last year Claris' US distributor Sagent Pharmaceuticals and its customer Pfizer had reported that the Metronidazole injection USP IV bags were contaminated with fungi. After the alert, Claris itself had announced a nationwide recall of all lots of Ciprofloxacin, Metronidazole and Ondansetron from the country voluntarily.
The company is now also investing in machinery and equipment at the Bavla site. Claris currently has five plants at its Bavla campus near Ahmadabad, of which four are operational. The fifth plant is going to manufacture formulations, while the sixth plant will make propofol, one of the company's key products used as an anesthetic agent that accounts for 14.84 per cent of its total sales. This would more than double Claris' propofol manufacturing capacity. Claris has bagged an in-principle approval for Propofol in the European Union earlier this month, besides receiving approvals from Russia to market its Fluconazole and Levofloxacin injections, used for treating fungal and bacterial infections. Propofol, a flagship product of Claris, is an anesthetic product which is widely replacing other anesthetic drugs
| Company Name | CMP |
|---|---|
| Redington | 216.95 |
| Adani Enterprises | 3263.50 |
| Amrapali Industries | 15.35 |
| Rashi Peripheral | 341.75 |
| Compuage Infocom | 3.71 |
| View more.. | |
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MoneyWorks4Me rates and ranks mutual funds based on the following data-driven system:
Funds ranking in screeners: Performance Consistency and Quality are two parameters used for ranking funds for SIP. The ranking as follows GG, GO, GR, OG, OO, OR, RG, RO and RR.
With the same color-coded funds, the one with the higher Average 3-year rolling returns (over 5 to 10 years), the number that appears in the Performance tag, ranks higher.
Here is the summary:
The third tag Upside Potential is not relevant for SIP. It is relevant for lumpsum investments in Mutual Funds.
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