Dishman: Swiss arm completes inspection without observation

Dishman: Swiss arm completes inspection without observation

Pratik Shastri
/ Categories: Trending, DSIJ News

Ahmedabad-headquartered pharma API manufacturer, Dishman Carbogen Amics announced that no observation was found following the USFDA inspection of its subsidiary in Switzerland.

Dishman Carbogen Amcis’ wholly-owned subsidiary Carbogen Amcis AG's manufacturing site in Neuland, Switzerland, has successfully completed a U.S. Food and Drug Administration (USFDA) pre-approval inspection. The inspection was concluded with no Form 483 filed, thus confirming that no critical or major observation was raised during the inspection. The auditor will recommend the approval of API for which the audit was conducted.

The Hunzenschwil facility is one of Carbogen Amcis AG's four sites to offer development and manufacturing facilities for highly potent compounds. It is engaged in manufacturing products according to cGMP standards and is routinely inspected by Swissmedic, the FDA and external customers. The site also provides innovative solutions for the development and supply of drug substances and drug products to the pharmaceutical and biopharmaceutical industry players.

On Friday, the stock opened at Rs. 209.40 per share and at closing minutes it traded at Rs. 203.15 per share, down by 1.88 per cent on BSE. The benchmark BSE Sensex was at 37,100.67, up by 82.35 points or 0.22 per cent.

Previous Article IPO Analysis: Spandana Sphoorty Financial Limited
Next Article Technical Bits: Biocon forms bullish engulfing candle
Rate this article:
5.0

DALAL STREET INVESTMENT JOURNAL - DEMOCRATIZING WEALTH CREATION

Principal Officer: Mr. Shashikant Singh,
Email: principalofficer@dsij.in
Tel: (+91)-20-66663800

Compliance Officer: Mr. Rajesh Padode
Email: complianceofficer@dsij.in
Tel: (+91)-20-66663800

Grievance Officer: Mr. Rajesh Padode
Email: service@dsij.in
Tel: (+91)-20-66663800

Corresponding SEBI regional/local office address- SEBI Bhavan BKC, Plot No.C4-A, 'G' Block, Bandra-Kurla Complex, Bandra (East), Mumbai - 400051, Maharashtra.
Tel: +91-22-26449000 / 40459000 | Fax : +91-22-26449019-22 / 40459019-22 | E-mail : sebi@sebi.gov.in | Toll Free Investor Helpline: 1800 22 7575 | SEBI SCORES | SMARTODR