Slovenian regulators slam Polydrug API plant in India

By Gareth Macdonald contact

- Last updated on GMT

Polydrug Labs site in Maharashtra, India
Polydrug Labs site in Maharashtra, India

Related tags: European union, Beta blocker

Polydrug Laboratories chose not to log customer complaints about APIs made at its plants in Maharashtra according to Slovenian regulators.

The agency for medicinal products and medical devices of the Republic of Slovenia (Jazmp) logged its concerns on the European Union’s Eudra GMP database last night​, explaining that they are based on an inspection conducted on March 18.

The regulators said its inspectors observed 17 breaches of current good manufacturing practices at the facility, five of which it described as ‘major’ including that customer complaints were “deliberately unregistered in the official logbook.”

Other transgressions included that access to quality records is not controlled and that Polydrug failed to “address risks of cross contamination for APIs sent out to micronisation subcontractor​” both of which pose a “potential risk for the patient​.”

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has suspended certificates of suitability (CEP)​ for the seven active pharmaceutical ingredients (APIs) made at the three factories at the Polydrug site.

The affected APIs include the beta blockers metoprolol tartrate and metoprolol succinate, ferrous fumarate and the Pfizer-developed antifungal fluconazole, which is on the World Health Organisation’s (WHO) essential medicines list​.

Mumbai-headquartered Polydrug has yet to comment on the CEP suspension and all of the APIs involved were still listed as available on its website when this article was published.

The firm did not respond to a request for comment ahead of publication.

Related news

Show more

Related products

How to resolve sticking issues in tablet production

How to resolve sticking issues in tablet production

I Holland Limited - Tabletting Science | 24-Jun-2019 | Case Study

Tablet sticking is one of the most common problems in tablet manufacture. Find out how I Holland used the TSAR scientific predictive model and expert tablet...

How to measure powder and granule flow properties

How to measure powder and granule flow properties

Stable Micro Systems | 01-Apr-2019 | Technical / White Paper

Being able to predict, optimise and control powder flow is of prime importance to manufacturers in ensuring high quality standards. Download this free...

Strategies to Select and Deliver the Right Candidate

Strategies to Select and Deliver the Right Candidate

Catalent Pharma Solutions | 05-Mar-2018 | Technical / White Paper

Does your candidate have what it takes to succeed? Do you have the information needed to make the right decisions about your candidate’s path to the clinic?...

Related suppliers

Follow us

Products

View more