Pharmaceutics International Inc.

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
Current status:
European Commission final decision



Pharmaceutics International Inc, US: supply of non-critical medicines to EU stopped due to manufacturing failings

Ammonaps may still be supplied where no alternatives are available

On 15 September the European Medicines Agency (EMA) recommended that medicines manufactured by Pharmaceutics International Inc, located in the United States, should no longer be available in the EU, except Ammonaps (sodium phenylbutyrate), which is considered critical for public health.

The recommendation was the outcome of a review of good manufacturing practice (GMP) at Pharmaceutics International Inc. The review was started after a follow-up inspection of the site by the UK medicines regulatory agency (MHRA) and the US FDA. This inspection found that corrective measures previously agreed had not been appropriately implemented. In particular, several manufacturing shortcomings had not been resolved. These related to the risk of cross-contamination (the possible transfer of one medicine to another) and deficiencies in the systems for ensuring medicines' quality (quality assurance).

Although there was no evidence of a defect in any of the medicines produced at the site or of harm to patients, the site was required to implement corrective measures to ensure compliance with GMP standards.

The recommendation from EMA's Committee for Medicinal Products for Human Use (CHMP) has the following impact on availability of medicines from Pharmaceutics International Inc:

  • Ammonaps, a medicine for treating urea cycle disorders which is exclusively manufactured at Pharmaceutics International Inc, remains available where there are no treatment alternatives. In EU countries where treatment alternatives exist, Ammonaps will be recalled.
  • SoliCol D3 (cholecalciferol), a medicine for vitamin D deficiency which is also exclusively produced at Pharmaceutics International Inc but has not yet been marketed in the EU, will not be made available in the EU. The medicine is only to be marketed once evidence is provided that its manufacturing is compliant with GMP standards.
  • The medicines Dutasteride Actavis (dutasteride), Lutigest/Lutinus (progesterone), and associated names, are registered to be produced at Pharmaceutics International Inc, but are now manufactured at alternative registered manufacturing sites. The medicines from these alternative sites therefore remain available in the EU. For Lutigest/Lutinus, some batches produced at the US site were still available on the EU market and were to be recalled.

The CHMP's recommendation concerning these medicines were sent to the European Commission, which issued a legally binding decision valid throughout the EU.

Key facts

About this medicine
Approved name
Pharmaceutics International Inc.
International non-proprietary name (INN) or common name
  • sodium phenylbutyrate
  • progesterone
  • dutasteride
  • colecalciferol
Associated names
About this procedure
Reference number
Article 31 referrals

This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

European Commission final decision
Key dates and outcomes
CHMP opinion date
EC decision date

All documents

Description of documents published

Please note that some of the listed documents apply only to certain procedures.

  • Overview - lay-language summary of the stage of the procedure
  • Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
  • Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
  • List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
  • Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
  • List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
  • List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
  • Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
  • Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
  • Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
  • Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
  • Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
  • Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
  • Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
  • Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)

Note that older documents may have different titles.


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