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2020 |
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|
Date |
Product |
Manufacturer |
Market authorization holder |
batch /batches |
Remark |
|
15.12.2020 |
Warfarin Tablets BP (All strength) |
Centurion remedies Pvt Ltd, G/5 and G/6, Industrial Estate Gorwa, Vadodara-390016, Gujarat, India |
Yaden International Pvt Ltd |
All batches |
The product withdrawal decision was revoked by the Medicines Evaluation Committee |
|
2021 |
|||||
|
Date |
Product |
Manufacturer |
Market authorization holder |
batch /batches |
Remark |
|
23.08.2021 |
Bupivacaine HCl in Dextrose Inj USP 5mg/80mg |
Ciron drugs and pharmaceuticals Pvt Ltd,N-118, 119, 113, 119/1, 119/2 &118/1, MIDC, Tarapur, Boisar, Dist.Palghar-401506, India |
Ceyoka Pvt Ltd |
0EB02119 |
batch withholding decision on was revoked based on NMQAL recommendation |
|
10.12.2021 |
Low Calcium (2.5mEq/L) Peritonial Dislysis Solution with Dextrose 1.5%w/v (Peritone) |
Peritone Health Sdn.Bhd, Lot 12, Industrial Zone 4, Kulim Hi-Tech Park, Kedah, Malaysia |
Infuxion Lanka Pvt Ltd |
L10182 L10205C1 L10205C2 |
Batch withholding decision was revoked based on the NMQAL recommendation on 10.12.2021. the decision was changed to discontinue to use containers which show the defect (Leakage) |
|
10.12.2021 |
Low Calcium (2.5mEq/L) Peritonial Dislysis Solution with Dextrose 2.5%w/v |
Peritone Health Sdn.Bhd, Lot 12, Industrial Zone 4, Kulim Hi-Tech Park, Kedah, Malaysia |
Infuxion Lanka Pvt Ltd |
L10202 |
Batch withholding decision was revoked based on the NMQAL recommendation on 10.12.2021. the decision was changed to discontinue to use containers which show the defect (Leakage) |
|
22.11.2021 |
PEG+ Electrolytes Powder for Oral Solution 69g (Klean Prep) |
Helsinn Birex Pharmaceuticals Ltd, Damastown, Mulhuddrt, Dublin 15, Ireland |
Hemas Pharmaceutical Pvt Ltd |
All batches |
The committee met on 22.11.2021 recommended to revoke the product withdrawal decision and initiate withdrawal of affected batches and batches expired in 2022. |
|
2022 |
|||||
|
Date |
Product |
Manufacturer |
Market authorization holder |
batch /batches |
Remark |
|
15.11.2022 |
Amoxicillin Capsules BP 500mg |
SPMC, Sri Lanka |
HLF02, HLH25 |
batch withdrawal decision was revoked based on NMQAL recommendation |
|
|
2023 |
|||||
|
Date |
Product |
Manufacturer |
Market authorization holder |
batch /batches |
Remark |
|
03.05.2023 |
Metoprolol Tartrate Tablets BP 50mg |
Centurion remedies Pvt Ltd, G/5 and G/6, Industrial Estate Gorwa, Vadodara-390016, Gujarat, India |
Yaden International Pvt Ltd |
TM-190026 |
batch withholding decision was revoked based on NMQAL recommendation |
NOTE:- It is mandatory for all applicants to submit,
1). Duly filled relevant application with the updated document list.
2). Duly filled acknowledgement form.
3). Check list marked with the available documents.
(Document list should be marked under availability column of the check list).
| This requirments will be in effective from 15/03/2023 onwards |
| Designation | Telephone | Fax | |
| Chairman | +94 112 303 156 | This email address is being protected from spambots. You need JavaScript enabled to view it. | |
| Chief Executive Officer |
+94 112 695 173 +94 112 303 072 |
+94 112 689 704 | This email address is being protected from spambots. You need JavaScript enabled to view it. |
| Director / NMQAL | +94 112 687 741 | - | This email address is being protected from spambots. You need JavaScript enabled to view it. |
| Section | Telephone | Extension |
| Regulatory Information Services (RIS) | ||
|
RIS acts as the point of contact for Market Authorization holders and their representatives. (Weekdays 08.30 - 16.00) |
||
| Medicine Regulatory Division | +94 112 698 896 | 383/393/311/320 |
| Device Regulatory Division | +94 112 698 896 | 416/315 / 408 |
| Borderline products Regulatory Division | +94 112 698 896 | 415/391/389 |
| Cosmetic Regulatory Division | +94 112 698 896 | 319 / 308 |
| Manufacturing Regulatory Division | +94 112 671 038 | 427 / 420 / 421 |
| Pharmacy Regulatory Division | +94 112 698 896 | 344 |
| Finance Division | +94 112 303 157 | |
| Legal Division | +94 112 303 158 | |
| Law Enforcement Division | +94 112 303 162 | |
| Administrative Officer | +94 112 303 124 | |
NOTE:- It is mandatory for all applicants to submit,
1). Duly filled relevant application with the updated document list.
2). Duly filled acknowledgement form.
3). Check list marked with the available documents.
(Document list should be marked under availability column of the check list).
| This requirments will be in effective from 15/03/2023 onwards |
Ministry of Health, Nutrition &
World Health OrganizationImport and ExportSri LankaNational Dangerous Drugs
Medicines & Healthcare products Regulatory Agency
Pharmaceuticals and Medical Devices Agency
Medical Research Institute Sri LankaSri Lanka Standards InstitutionDepartment of Ayurveda
