This document discusses opportunities for generic drug applications in Pakistan. It lists over a dozen generic drug products where the patents have expired but no generic has been approved yet. It encourages independently assessing the strength of established conditions, critical quality attributes, critical processing parameters, control strategy, and quality management system for consistent production of drugs without contamination. Submitting applications to the regulatory agency could help move the generic drug industry forward in Pakistan.

1. Obaid & Roohi
Centre for Quality Sciences
Ref #:200620-3
832-C, Block 2, PECHS, Karachi. obaidali1971@gmail.com 0321-5150061
Keep the Wheel Moving On & Create a Difference
Background: A number of drugs complete their patent and exclusivity. No generic
has yet been approved. There is no restriction to submit application.
The transparency and science focus approach guarantee merit and
one can predict the fate of application well before submission.
Opportunity: Decades of experience to manufacture particular drugs here in
Pakistan requires to think what is not yet thought of. It is
encouraging for everyone to pursue and submit application to the
FDA.
Way to Move Forward: Assess independently the strength of Established Conditions (EC)
of your product by mapping the Critical Quality Attributes (CQAs),
Critical Processing Parameters (CPPs), Control Strategy (CS), as
well as your Quality Management System (QMS) responsible to
produce consistent product without contamination and mix up every
time.
Name of Products: Azithromycin Suspension
Ciprofloxacin Ointment
Ceftazidime Injection, Cefazolin Injection
Dexamethasone & Tobramycin Ointment
Dextrose, Sodium Chloride IV Bags
Drospirenone Estradiol Tablet
Estradiol Gel
Hydrochlorothiazide, Spironolactone Tablet
Magnesium Chloride Injection
Meropenem Powder for Injection
Moxifloxacin HCl Solution
Penicillin G Injection
Verapamil HCl Capsule Extended Release
Etc. etc.
Reference: FDA - June 18th
2020
Obaid Ali
Chief Executive
Karachi - June 20, 2020