| 1 | SURGIPHARM LTD | 221 | Atrovent 20 HFA | Human | Foreign | Ipratropium bromide | Ipratropium bromide corresponding to ipratropium… | 9000 | Pressurised Inhalation | RESPIRATORY (INHALATION) | 24 months | Clear, colourless solution in aluminium canister… | R03BB | Other drugs for obstructive airway diseases… | Boehringer Ingelheim international GmbH | Binger StraBe 173 55216 Ingelheim am Rhein Germany | info@boehringer-ingelheim.de | Boehringer Ingelheim Pharma GmbH & Co. KG, | 173 Binger Strasse, 55216, Ingelheim am Rhein,… | Withdrawn | Initiated by the client | GMP Site is Invalid |
| 2 | NVS KENYA LTD | 263 | Baneocin Powder | | Foreign | Bacitracin+Neomycin | BACITRACIN ZINC+NEOMYCIN SULPHATE PWD 250 IU +… | 1315 | Powder And Solvent For Cutaneous Solution | TOPICAL | 36 months | Baneocin powder is a fine white to yellowish… | D06AX | Other antibiotics for topical use | Sandoz GmbH Kundl | Biochemiestrasse 10A-6250 Kundl / TirolAustria. | winnie.munene@sandoz.com | MONTAVIT GES. MBH | SALZBERGSTR. 96, A-6067 ABSAM, AUSTRIA | Withdrawn | Initiated by the client | GMP Site is Invalid |
| 3 | SURGIPHARM LTD | 307 | Atrovent 500 mcg UDV | Human | Foreign | Ipratropium bromide | 0.5 mg ipratropium bromide (anhydrous) per 2 ml… | 10090; H95/139 | Inhalation Vapour, Solution | RESPIRATORY (INHALATION) | 24 months | Clear, colourless or almost colourless solution | R03BB | Other drugs for obstructive airway diseases… | Boehringer Ingelheim international GmbH | Binger StraBe 173 55216 Ingelheim am Rhein Germany | info@boehringer-ingelheim.de | LABORATOIRE UNITHER | 80084 AMIENS CEDEX, FRANCE | Withdrawn | Initiated by the client | GMP Site is Invalid |
| 4 | PHILLIPS THERAPEUTICS LIMITED | 590 | GLURENOR | | Foreign | Gliquidone | 30 mg | 9711 | Tablet | ORAL | 48 months | Flat round white bevel-edged tablets scored on… | A10BB | Blood glucose lowering drugs excluding insulins:… | Laboratori Guidotti S.p.A. | Via Livornese 897 56122- La Vettola Pisa Italy | prijli@menarini.it | A. Menarini Manufacturing Logistics and Services… | Via Campo di Pile, 67100 L Aquila Italy | Withdrawn | Initiated by the client | GMP Site Approved |
| 5 | CADILA PHARMACEUTICALS EAST AFRICA LIMITED | 750 | ACILOC 150 | | Foreign | RANITIDINE | 150MG | 8386 | Coated Tablet | ORAL | 36 months | Green coloured film coated smooth round biconvex… | A02BA | Drugs for peptic ulcer and gastro-oesophageal… | CADILA PHARMACEUTICALS (EA) LTD | P.O. BOX 79642-00200 | cadila@swiftkenya.com | CADILA PHARMACEUTICALS LTD | 1389, TRASAD ROAD, DHOLKA 387810, DIST.… | Revoked | Regulatory decision on Safety or Quality issues. | GMP Site is Invalid |
| 6 | CADILA PHARMACEUTICALS EAST AFRICA LIMITED | 768 | ACILOC 300 | | Foreign | RANITIDINE | 300MG | 8387 | Coated Tablet | ORAL | 36 months | Green coloured capsule shaped biconvex film… | A02BA | Drugs for peptic ulcer and gastro-oesophageal… | CADILA PHARMACEUTICALS (EA) LTD | P.O. BOX 79642-00200 | cadila@swiftkenya.com | CADILA PHARMACEUTICALS LTD | 1389, TRASAD ROAD, DHOLKA 387810, DIST.… | Revoked | Regulatory decision on Safety or Quality issues. | GMP Site is Invalid |
| 7 | HIGHRIDGE PHARMACEUTICALS LTD | 829 | Ranidin Injection | | Foreign | Ranitidine hydrochlroride | Each 2ml inj contains Ranitidine hydrochlroride… | H2006/562 | Injection | INTRAMUSCULAR | 24 months | Light yellow colored clear liquid in an amber… | A02BA | Drugs for peptic ulcer and gastro-oesophageal… | The ACME Laboratories Ltd | Dhulivita, Dhamrai, Dhaka, Bangladesh | tmahmood.export@acmeglobal.com | THE ACME LABORATORIES LTD | DHULIVITA, DHAMRAI, DHAKA, BANGLADESH | Revoked | Regulatory decision on Safety or Quality issues. | GMP Site is Invalid |
| 8 | CADILA PHARMACEUTICALS EAST AFRICA LIMITED | 1004 | ACILOC INJECTION | | Foreign | RANITIDINE | 25MG/ML | 10483 | Solution For Injection | INTRAVENOUS | 24 months | A clear colourless to pale yellow solution free… | A02BA | Drugs for peptic ulcer and gastro-oesophageal… | CADILA PHARMACEUTICALS (EA) LTD | P.O. BOX 79642-00200 | cadila@swiftkenya.com | CADILA PHARMACEUTICALS LTD | 1389, TRASAD ROAD, DHOLKA 387810, DIST.… | Revoked | Regulatory decision on Safety or Quality issues. | GMP Site is Invalid |
| 9 | SURGIPHARM LTD | 1014 | Jentadueto 2,5 mg/850 mg Tablets | | Foreign | Linagliptin & Metformin HCl | 2,5 mg & 850 mg/film-coated tablet | H2013/CTD1294/345 | Film-Coated Tablet | ORAL | 24 months | JENTADUETO 2,5 mg/850 mg film-coated tablets are… | A10BD | Combinations of oral blood glucose lowering drugs | Boehringer Ingelheim international GmbH | Binger StraBe 173 55216 Ingelheim am Rhein Germany | info@boehringer-ingelheim.de | Boehringer Ingelheim Pharma GmbH & Co. KG, | 173 Binger Strasse, 55216, Ingelheim am Rhein,… | Withdrawn | Initiated by the client | GMP Site is Invalid |
| 10 | SURGIPHARM LTD | 1100 | METALYSE 8 000 U and Solvent | Human | Foreign | Tenecteplase | Tenecteplase 8 000 units. The reconstituted… | 15128 | Powder And Solution For Solution For Injectio | INTRAVENOUS DRIP | 24 months | Powder for IV infusion: white to pale yellow… | B01AD | Antithrombotic agents: Enzymes | Ingelheim Pharmaceuticals (Pty) Ltd | 404 Main Avenue Ferndale Randburg South Africa | fiona.smith@boehringer-ingelheim.com | Boehringer Ingelheim Ellas A.E (Koropi Plant) | 5th KM Paiania-Markopoulo, Koropi Attiki, 19400,… | Withdrawn | Initiated by the client | GMP Site Approved |