montelukast (as sodium) (CIPLA MONTELUKAST 10) 10 mg film-coated tablet blister pack, Biotech Regulatory Solutions Pty Ltd, CON-76
Product name
montelukast (as sodium) (CIPLA MONTELUKAST 10) 10 mg film-coated tablet blister pack
Sponsor name
Biotech Regulatory Solutions Pty Ltd
Consent start
Consent no.
CON-76
Standard
British Pharmacopoeia (BP) 2016 monographs for chewable Montelukast Tablets and Montelukast Tablets.
Non-compliance with standard
The products do not comply with the requirement for 'Impurity B'.
Therapeutic product type
Prescription medicines