Health Canada bans psychotropic drugs made in India

[David Baxter PhD]

Products affected by action to stop imports from ARPL, APIPL and IPCA facilities in India
Health Canada
September 30, 2014

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 applies to finished products from ARPL, as well as active pharmaceutical ingredients (APIs) and products made with APIs from APIPL and IPCA. Health Canada has compiled an initial list of products affected by the import ban. The list will be updated as new information becomes available.

Product Name	DIN	Strength
Apo-Azithromycin	02247423	250 mg
Apo-Azithromycin Z	02415542	250 mg
Apo-Candesartan	02365340	4 mg
...	02365359	8 mg
...	02365367	16 mg
...	02399105	32 mg
Apo-Candesartan/HCTZ	02367866	16/12.5 mg
...	02395126	32/12.5 mg
...	02395134	32/25 mg
Desloratadine	02338424	5 mg
Apo-Donepezil	02362260	5 mg
...	02362279	10 mg
Apo-Eletriptan	02386054	20 mg
...	02386062	40 mg
Apo-Enalapril	02019884	5 mg
...	02019906	20 mg
...	02020025	2.5 mg
...	02019892	10 mg
Apo-Enalapril/HCTZ	02352923	5/12.5 mg
...	02352931	10/25 mg
Apo-Entecavir	02396955	0.5 mg
Apo-Frovatriptan	02426471	2.5 mg
Apo-Irbesartan	02386968	75 mg
...	02386976	150 mg
...	02386984	300 mg
Apo-Irbesartan/HCTZ	02387646	150/12.5 mg
...	02387654	300/12.5 mg
...	02387662	300/25 mg
Apo-Linezolid	02426552	600 mg
Teva-Linezolid Injection	02402637	2 mg/ml
Apo-Losartan	02353504	50 mg
...	02353512	100 mg
...	02379058	25 mg
Apo-Losartan/HCTZ	02371235	50/12.5 mg
...	02371243	100/12.5 mg
...	02371251	100/25 mg
Apo-Montelukast FCT	02374609	10 mg
Apo-Montelukast TAB	02377608	4 mg
...	02377616	5 mg
Apo-Mycophenolate CAP	02352559	250 mg
Apo-Mycophenolate FCT	02352567	500 mg
Apo-Mycophenolate ECT	02372738	180 mg
...	02372746	360 mg
Apo-Pregabalin	02394235	25 mg
...	02394243	50 mg
...	02394251	75 mg
...	02394278	150 mg
...	02394286	225 mg
...	02394294	300 mg
Apo-Riluzole	02352583	50 mg
Apo-Rizatriptan TAB	02393468	5 mg
...	02393476	10 mg
Apo-Rizatriptan ODT	02393484	5 mg
...	02393492	10 mg
Apo-Sildenafil TAB	02248201	25 mg
...	02248202	50 mg
...	02248203	100 mg
Apo-Sildenafil R	02418118	20 mg
Apo-Telmisartan	02420082	40 mg
...	02420090	80 mg
Apo-Valganciclovir	02393824	450 mg
Apo-Valsartan	02371510	40 mg
...	02371529	80 mg
...	02371537	160 mg
...	02371545	320 mg
Apo-Valsartan/HCTZ	02382547	80/12.5 mg
...	02382555	160/12.5 mg
...	02382563	160/25 mg
...	02382571	320/12.5 mg
...	02382598	320/25 mg
Apo-Voriconazole	02409674	50 mg
...	02409682	200 mg

API name	Product Name	DIN	Strength
Almotriptan	Apo-Almotriptan	02405792	6.25 mg
...	02405806	12 mg
Candesartan	Apo-Candesartan	02365367	16 mg
...	02399105	32 mg
...	02365340	4 mg
...	02365359	8 mg
Candesartan/HCTZ	Apo-Candesartan/HCTZ	02367866	16/12.5 mg
...	02395126	32/12.5 mg
...	02395134	32/25 mg
Eletriptan	Apo-Eletriptan	02386054	20 mg
...	02386062	40 mg
Enalapril	Apo-Enalapril	02020025	2.5 mg
...	02019884	5 mg
...	02019892	10 mg
...	02019906	20 mg
Enalapril/HCTZ	Apo-Enalapril/HCTZ	02352923	5/12.5 mg
...	02352931	10/25 mg
Entecavir	Apo-Entecavir	02396955	0.5 mg
Exemestane	Apo-Exemestane	02419726	25 mg
Lansoprazole	Apo-Lansoprazole	02293811	15 mg
...	02293838	30 mg
Mycophenolate Mofetil	Apo-Mycophenolate	02352559	250 mg
...	02352567	500 mg
Mycophenolate Sodium	Apo-Mycophenolic Acid	02372738	180 mg
...	02372746	360 mg
Olopatadine	Apo-Olopatadine	02305054	0.1% solution
...	02402823	0.2% solution
Pramipexole	Apo-Pramipexole	02292378	0.25 mg
...	02292386	0.5 mg
...	02292394	1 mg
...	02292408	1.5 mg
Raloxifene	Apo-Raloxifene	02279215	60 mg
Ramipril	Apo-Ramipril	02251515	1.25 mg
...	02251531	2.5 mg
...	02251574	5 mg
...	02251582	10 mg
...	02325381	15 mg
Riluzole	Apo-Riluzole	02352583	50 mg
Risperidone	Apo-Risperidone	02282119	0.25 mg
...	02282127	0.50 mg
...	02282135	1 mg
...	02282143	2 mg
...	02282151	3 mg
...	02282178	4 mg
Rizatriptan benzoate	Apo-Rizatriptan	02393468	5 mg
...	02393476	10 mg
Apo-Rizatripan RPD	02393484	5 mg
...	02393492	10 mg
Tizanidine	Apo-Tizanidine	02259893	4 mg
Valgancicolvir	Apo-Valganciclovir	02393824	450 mg
Voriconazole	Apo-Voriconazole	02409674	50 mg
...	02409682	200 mg
Alprazolam	Apo-Alpraz TAB	00865397	0.25mg
...	00865400	0.5mg
...	02243611	1.0mg
Apo-Alpraz TS	02243612	2.0mg
Finasteride	Apo-Finasteride	02365383	5mg
Alfuzosin Hydrochloride	Apo-Alfuzosin	02315866	10mg
Atomoxetine HCl	Apo-Atomoxetine	02318024	10mg
...	02318032	18mg
...	02318040	25mg
...	02318059	40mg
...	02318067	60mg
...	02318075	80mg
...	02318083	100mg
Memantine HCl	Apo-Memantine	02366487	10mg
Olanzapine	Apo-Olanzapine	02281791	2.5 mg
...	02281805	5 mg
...	02281813	7.5mg
...	02281821	10.0mg
...	02281848	15.0mg
...	02333015	20.0mg
Apo-Olanzapine ODT	02360616	5.0mg
...	02360624	10.0mg
...	02360632	15.0mg
...	02360640	20.0mg
Pantoprazole Sodium Sesquihydrate	Apo-Pantoprazole	02292912	20mg
...	02292920	40mg
Risedrondate Sodium Hemipentahydrate	Apo-Risedronate	02353687	35mg
...	02377721	150mg
Rivastigmine Tartrate	Apo-Rivastigmine	02336715	1.5mg
...	02336723	3.0mg
...	02336731	4.5mg
...	02336758	6.0mg

API name	Importer	Finished Product	DIN	Strength
Atenolol	Ranbaxy	Ran-Atenolol	02373963	25 mg
...	02267985	50 mg
...	02267993	100 mg
Teva	Ratio-Atenolol	02171805	100 mg
...	02171791	50 mg
Pharmascience	PMS-Atenolol	02237600	50 mg
...	02237601	100 mg
...	02246581	25 mg
Sivem	Atenolol	02238318	100 mg
...	02247182	25 mg
...	02238316	50 mg
PRO DOC	Atenolol	02326701	25 mg
...	00828807	50 mg
...	00828793	25 mg
Apotex	Apo-Atenolol	00773697	100 mg
...	00773689	50 mg
Atenidone (Atenolol/Chlorthalidone)	02248763	50/25mg
...	02248764	100/25 mg
Actavis/Cobalt	CO Atenolol	02255545	50 mg
...	02255553	100 mg
IPG	MAR-Atenolol	02371979	25 mg
...	02371987	50 mg
...	02371995	100 mg
Bio-Atenolol	02392194	25 mg
...	02392178	50 mg
...	02392186	100 mg
AstraZeneca Canada	Tenormin	02039532	50 mg
...	02039540	100 mg
Biomed 2002 Inc	Bio-Atenolol	02392178	50 mg
...	02392186	100 mg
...	02392194	25 mg
Losartan	Mint Pharmaceuticals	Mint-Losartan	02405741	50 mg
...	02405768	100 mg
Pharmascience	PMS-Losartan	02309750	25 mg
...	02309769	50 mg
...	02309777	100 mg
Ranbaxy	Ran-Losartan	02404451	25 mg
...	02404478	50 mg
...	02404486	100 mg
Losartan/HCTZ	Mylan Pharmaceuticals	Losartan/HCTZ	02378078	50/12.5 mg
...	02378086	100/12.5 mg
...	02378094	100/25 mg
Teva	TEVA-Losartan/HCTZ	02358263	50/12.5 mg
Candesartan Cilexetil	Mylan Pharmaceuticals	Candesartan/HCTZ	02374897	16/12.5 mg
Sandoz (Turkey)	Sandoz Candesartan Plus	02327902	16/12.5 mg
...	02420732	32/12.5 mg
...	02420740	32/25 mg
Lisinopril	Mylan Pharmaceuticals	Lisinopril/HCTZ	02297736	10/12.5 mg
...	02297744	20/12.5 mg
...	02297752	20/25 mg
Telmisartan/HCTZ	Pro DOC Ltee	Telmisartan-HCTZ	02395525	80/12.5 mg
...	02395533	80/25 mg
Mylan Pharmaceuticals	Telmisartan/HCTZ	02373564	80/12.5 mg
...	02373572	80/25 mg
Teva Canada Ltd	Teva-Telmisartan HCTZ	02330288	80/12.5 ng
...	02379252	80/25 mg
Sandoz	Sandoz Telmisartan HCT	02393557	80/12.5 mg
...	02393565	80/25 mg
Sivem	Telmisartan/HCTZ	02390302	80/12.5 mg
...	02390310	80/25 mg
Valsartan	Mylan Pharmaceuticals	Valsartan/HCTZ	02373734	80/12.5 mg
...	02373742	160/12.5 mg
...	02373750	160/25 mg
...	02373769	320/12.5 mg
...	02373777	320/25 mg
Teva Canada Ltd	Teva-Valsartan HCTZ	02357003	160/12.5 mg
...	02357011	160/25 mg
...	02357038	320/12.5 mg
...	02357046	320/25 mg
...	02356996	80/12.5 mg
Carvedilol	Ranbaxy	Ran-Carvedilol	02268027	3.125 mg
...	02268035	6.25 mg
...	02268043	12.5 mg
...	02268051	25 mg
Sivem	Carvedilol	02248754	12.5 mg
...	02248755	25 mg
...	02248752	3.125 mg
...	02248753	6.25 mg
Chlorthalidone	Takeda Canada Inc	Edarbyclor Azilsartan Medoxomil/Chlorthalidone	02397749	40/12.5 mg
...	02397765	40/25 mg
...	02397757	80/12.5 mg
Irbesartan	Teva Canada	Ratio-Irbesartan HCTZ	02330539	300/25 mg
...	02330512	150/12.5
...	02330520	300/12.5 mg
...	02316013	150/12.5 mg
...	02316021	300/12.5 mg
...	02316048	300/25 mg
Sandoz	Sandoz Irbesartan HCT	02337428	150/12.5 mg
...	02337436	300/12.5 mg
...	02337444	300/25 mg
Metoclopramide	Pharmascience	Metonia	02230431	5 mg
...	02230432	10 mg
...	02230433	1 mg/ml
Apotex	Metoclopramide	00842834	10 mg
...	00842826	5 mg
Metoprolol	Pharmascience	PMS-Metoprolol-B	02145421	100 mg
...	02145413	50 mg
PMS-Metoprolol-L	02230803	50 mg
...	02230804	100 mg
...	02248855	25 mg
Furosemide	Sandoz	Furosemide for injection	00527033	10 mg/ml
...	00401633	10 mg/ml
Apotex	Furosemide oral	00396788	20 mg
...	00362166	40 mg
...	00707570	80 mg
Pro Doc Ltee	Furosemide oral	00496723	20 mg
...	00397792	40 mg
...	00667080	80 mg
Famotidine	Apotex	Acid Control (OTC)	02240414	10 mg
...	02296098	20 mg
Apo-Famotidine	02231119	10 mg
...	01953842	20 mg
...	01953834	40 mg
Hydroxychloroquine Sulfate	Apotex	Hydroxychloroquine Sulfate	02246691	200 mg
Pro Doc	Hydroxychloroquine Sulfate	02311011	200 mg
Methylphenidate	Apotex	Apo-Methylphenidate	02273950	10 mg
...	02249324	20 mg
...	02249332	5 mg
Apotex	Apo-Methylphenidate SR	02266687	20 mg
Allopurinol	IPG	Mar-Allopurinol	02396327	100 mg
...	02396335	200 mg
...	02396343	300 mg
Quetiapine	IPG	Mar-Quetiapine	02399822	25 mg
...	02399830	100 mg
...	02399849	200 mg
Tramadol	Ranbaxy	Ran-Tramadol/Acet	02388197	37.5/325 mg
Veterinary Drugs
Trimethprim (VET DRUG)	Intervet	Borgal	00555657	200 mg/ml
...	...	40 mg/ml
Salix	Furosemide	00116238	50 mg/ml

 

[Retired]

Attached is a copy of the list for download / viewing / printing

 

[David Baxter PhD]

Thank you Steve


Sent from my iPhone using Tapatalk