Regulatory & audits

Compliance and Regulatory Affairs

FDA and other Certifications

Hovione was first approved by the FDA in 1982. Inspections took place in 1982, 84, 86, 87, 89, 91, 93, 95, 96, 98, 2000, 2001, 2004, 2005 and 2007- on 5 occasions no Form 483 was issued.

At Loures plant the last FDA inspection took place in September 2005. The last six inspections have been pre-approval inspections.

The Macao plant was first approved by the FDA in 1987, and last inspected in 2004. The plant was last inspected by the Australian TGA in 1996 and by Portuguese Health Authority (INFARMED) in September 2006. This plant is also certified under ISO9001:2000.

The TTC Plant located in New Jersey District was first inspected by FDA last October 2007. No Form 483 was issued.

Hovione Loures plant is regularly inspected by the Portuguese health authority agency equivalent to the FDA, INFARMED, and is approved for the manufacture of active ingredients as well as for Investigational Medicinal Products according with the European directive 2003/94/EC Annex 13. The last inspection was in January 2007.

Hovione's Forms 483 and EP Certificates can be accessed online using a password which you can obtain upon request. Please e-mail us at indicating your details and reasons for request.

Hovione has undergone no fewer than 15 FDA inspections over a 23-year period. Over that time, no warning letter has ever been issued and, of the 10 Form 483s received, all were addressed satisfactorily within 30 days.


Regulatory Filings

Hovione has filings with every world health authority that has a DMF system for APIs. The Regulatory Group with a staff of 3 and over 20 years experience in dealing with the FDA, is able to prepare data for an IND, NDA, ANDA, VMF or DMF filed at the FDA, MCA, HPB, TGA, Agence du Médicament, BfArM, or for EP certification, having successfully completed the relevant filing requirements many times. The Regulatory group works closely with R&D, Analysis and Quality Assurance Departments to coordinate work requirements from an FDA submission’s point of view; this includes reports necessary on chemical characterization, impurity profiles, stability, development, worst case reports, etc. Hovione currently supplies APIs under NDAs or DMFs for oral, topical, inhalation and injectable grade. It is Company policy to keep up-dated and informed on current and future requirements at FDA.


We are audited into best practice

Over the last 3 years, our facilities have been inspected by more than 50 different audit teams, with about half conducted by repeat-customers carrying out repeat-audits. This represents more than 75 person days of auditing time; (this number excludes our own internal audit program). Hovione listens very carefully to what customers and regulators say during audits. The Hovione Quality group is open to new ideas and is always willing to discuss quality issues with its peer group. Being "audited into best practice" is part of our business model and a commitment to continuous improvement is a cornerstone of the Company's culture.

Hovione always welcomes customers to visit our facilities, allowing them to audit projects or simply view the manufacturing process in person. Frequent customer and regulatory audits further contribute to assure compliance.
Quality Audits can be arranged with the GMP Compliance Director. Prior to a Quality Audit, we usually supply the customer with a "Pre-Audit Assessment Document" which gives a detailed account of our operations thus enabling the Auditor to better prepare his visit. This document can be obtained upon request and signature of a CDA by contacting us at
Hovione Loures is easily accessible being located 10 minutes by car from Lisbon's International Airport. We will be pleased to welcome you to Portugal and to our manufacturing plant.


Participation in Pharmacopeial matters

Hovione actively corresponds with the various Pharmacopoeia Commissions (USP, BP, EP and JP) on matters of analytical techniques, reference standards and monographs. We extensively cooperate with USP and EP in the development of new monographs and analytical methods (which have been adopted) and have supplied USP and EP with several bulk products which are issued by them as their reference standard. This has covered doxycycline, methacycline, minocycline, beclomethasone and iopamidol and their related impurities.

If you would like to arrange an audit to Hovione's plants please contact: