In our quest to expand access to high-quality generic medicines at affordable prices, we continue to increase our reach to newer markets and geographies. With a growing number of accreditations, the International Business of SAVA Healthcare Limited offers clients a portfolio of Pharmaceuticals, Herbals and Animal Health products.
Our core business regions are:
- Ukraine and the CIS
- Africa, especially FWA
Our Regulatory Affairs team keeps track of the ever-changing legislations in all the regions in which the company intends to market its products. We are capable of all types of regulatory submissions (Dossiers / ANDA / ANDS / CTD / e CTD) for any of the semi-regulated to highly regulated markets ensuring fast turnaround in business.
Dossier development as per CTD / ACTD requirements.
Artwork / product labeling development as per country’s requirement.
Accurate and specific Analytical and Chemical, Manufacturing and control (CMC) data support.
Indian FDA documents support, required for product registration.
GMP audit assistance.
Interactions with regulatory authorities as and when required.
Regulatory compliance gap analysis and solution.
On time product registration renewal.
|GENERIC NAME||BRAND NAME||REGISTRATION COUNTRY||PACK SIZE|
|POLYETHYLENE GLYCOL 3350 ORAL POWDER||–||CANADA||1X510G|
|SODIUM POLYSTYRENE ORAL POWDER||–||CANADA||1X454|
|CALCIUM POLYSTYRENE ORAL POWDER||–||CANADA||1X300G|
|METORPOLOL TABLETS 25 MG||–||CANADA||1X100,500T|
|METORPOLOL TABLETS 50 MG||–||CANADA||1X100,500T|
|METORPOLOL TABLETS 100 MG||–||CANADA||1X100,500T|
|PYRANTEL PAMOATE TABLETS 125 MG||–||CANADA||1X10T|
|LAMIVUDINE TABLETS USP 150 MG||–||CANADA||1X60T|
|LAMIVUDINE TABLETS USP 100 MG||–||CANADA||1X100T|
|LAMIVUDINE TABLETS USP 300 MG||–||CANADA||1X30T|
|BISOPROLOL TABLETS USP 2.5 MG||–||CANADA||1X100T|
|BISOPROLOL TABLETS USP 5 MG||–||CANADA||1X100T|
|BISOPROLOL TABLETS USP 10 MG||–||CANADA||1X100T|