Health Canada
Symbol of the Government of Canada

Common menu bar links

Drugs and Health Products

Products affected by action to stop imports from ARPL, APIPL and IPCA facilities in India

Updated: April 19, 2016

Health Canada took action on September 30, 2014 to stop the import of health products from the following sites in India:

  • Apotex Pharmachem India Pvt Ltd (APIPL)
  • Apotex Research Private Limited (ARPL)
  • IPCA Laboratories

The action applied to finished products from ARPL, as well as active pharmaceutical ingredients (APIs) and products made with APIs from APIPL and IPCA.

On August 31, 2015, Health Canada amended the terms and conditions on Apotex’s Establishment Licences for APIPL and ARPL as a result of an onsite inspection of corrective actions at these sites in June 2015.

On October 14, 2015, the Federal Court issued a judgment quashing the September 30, 2014 decision and the associated terms and conditions on Apotex's establishment licences, except with respect to IPCA.

On March 14, 2016, Health Canada issued a new decision which imposed no terms and conditions on Apotex’s Establishment Licences for products fabricated at APIPL and ARPL. As such, products fabricated at these two sites are not subject to any import restrictions. This decision was based on all available information, including new information provided by Apotex.  Products imported from these two sites have been removed from the table below.

These lists are based on the most recent information received by Health Canada as of April 19, 2016, from various importers and companies including Apotex, and include attested information submitted to Health Canada as part of the licensing process. The lists will continue to be updated as new information becomes available.

Medically Necessary Products

The following products have been identified as medically necessary by Health Canada and the list has been informed by input from the provinces and territories. This list is based on the most recent information received by Health Canada as of April 19, 2016. The list will continue to be updated as new information becomes available.

Medically Necessary Products
Company name Products Product Status
Actavis/Cobalt Co Atenolol Testing in progress, product being released
AstraZeneca Canada Tenormin Testing in progress, product being released
Biomed 2002 Bio-Atenolol Testing in progress, product being released
Dominion Pharmacal Dom-Atenolol Testing in progress, product being released
Intervet Canada Corp Salix (Furosemide) Testing in progress, product being released
Jamp Pharma Corporation Jamp-Atenolol Testing in progress, product being released
Jamp Losartan/HTCZ  
Jamp-Allopurinol Testing in progress, product being released
Laboratoire Riva Riva-Atenolol Testing in progress, product being released
Marcan Pharmaceuticals Mar-Atenolol Testing in progress, product being released
Mar-Allopurinol Testing in progress, product being released
Mint Pharmaceuticals Mint-Atenolol Testing in progress, product being released
Mint-Hydroxychloroquine  
Mylan Pharmaceuticals Candesartan/HCTZ  
Losartan/HCTZ  
Telmisartan/HCTZ  
Valsartan/HCTZ  
Pendopharm Metonia Testing in progress, product being released
Pharmascience PMS-Atenolol Testing in progress, product being released
PRO DOC Ltee Atenolol Testing in progress, product being released
Telmisartan/HCTZ Testing in progress, product being released
Ranbaxy Canada Ran-Atenolol Testing in progress, product being released
Sandoz Canada Sandoz Telmisartan HCT Testing in progress, product being released
Furosemide for injection Testing in progress, product being released
Sandoz Candesartan Plus  
Sanis Health Telminastran/HTCZ Testing in progress, product being released
Sivem Pharmaceuticals Atenolol Testing in progress, product being released
Telmisartan/HCTZ Testing in progress, product being released
Teva Canada Ltd Ratio-Atenolol Testing in progress, product being released 
Ratio-Irbesartan/HCTZ Testing in progress, product being released 
Teva-Losartan/HCTZ Testing in progress, product being released 
Teva-Telmisartan/HCTZ Testing in progress, product being released 
Teva-Valsartan/HCTZ Testing in progress, product being released 
Non Medically Necessary Products
Company name Products
Jamp Pharma Corporation Jamp-Carvedilol
Jamp-Metoprolol-L
Jamp -Pyrantel Pamoate
Laboratoire Riva Riva-Metoprolol-L
Marcan Pharmaceuticals Mar-Quetiapine
Mint Pharmaceuticals Mint-Losartan
Mylan Pharmaceuticals Lisinopril/HCTZ
Pharmascience PMS-Losartan
PMS-Metoprolol-B
PMS-Metoprolol-L
Ranbaxy Canada Ran-Losartan
Ran-Carvedilol
Takeda Canada Inc Edarbyclor Azilsartan Medoxomil/Chlorthalidone
Intervet Canada Corp Borgal (Trimethoprim)