From: Ashok Panwar [akpanwar@rediffmail.com] Sent: Thursday, October 21, 2004 5:18 AM To: fdadockets@oc.fda.gov Subject: Notice for Regulatory Site Visit Training Program IDRA/2004/220 21 October 2004 To : Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852 From : Dr. Ashok Panwar Subject : “Notice for Regulatory Site Visit Training Program” Sir/Madam, This has reference to your notice regarding Regulatory Site Visit Training Program, Federal register: September 23, 2004 (volume 69, Number 184), Page No. 57033-57034, Docket No.: 2004N-0408. I am writing on behalf of Panacea Biotec limited (PBL), an Indian Pharmaceutical company. Panacea Biotec limited (PBL) has been involved in the development and manufacturing of vaccines for the last 15 years and has been in the forefront of development and assimilating newer vaccines and technologies while striving to provide healthcare products to consumers on a continuous basis. PBL has a dedicated Research & Development Center for Vaccines and biologicals, having more than 30 scientists engaged in research activities. PBL also has cGMP compliant manufacturing facilities, one dedicated to manufacture bulk drug substances and the other for manufacturing finished drug products which is pre-qualified by WHO for supply to UN Agencies. We request you to kindly consider PBL as one of the site for Regulatory Site Visit Program. Looking forward to your coming shortly. With warm regards. For Panacea Biotec Ltd. (Dr. Ashok Panwar) Dy. GM - DRA (International) B-1 Ext./ G-3, Mohan Co-op. Indl. Estate, Mathura Road, New Delhi-110044, INDIA. Website : www.panacea-biotec.com Email : apanwar@pblintranet.com akpanwar@rediffmail.com Phone : 91-11-51679056 (O) 9811 990 283 (M)