| 1 | 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 MBH | SALZBERGSTR. 96, A-6067 ABSAM, AUSTRIA | Withdrawn | Initiated by the client | GMP Site is Invalid |
| 2 | 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| prijli@menarini.it | A. Menarini Manufacturing Logistics and Services… | Via Campo di Pile, 67100 L Aquila Italy | Withdrawn | Initiated by the client | GMP Site Approved |
| 3 | PHILLIPS THERAPEUTICS LIMITED | 1136 | SCHERIPROCT | | Foreign | Prednisolone hexanoate / Cinchocain HCl | 1 suppository contains: Prednisolone caproate 1.3… | 4125 | Suppository | RECTAL | 30 months | yellowish-white suppository | D07XA | Other Combinations of Weak Corticosteroids for… | Bayer Pharma AG | Bayer Pharma AG 13342 Berlin Germany | www.bayer.com | Bayer Health Care Manufacturing s.r.l. Segrate | Via E. Schering 21, 20090, Segrate (Milano), Italy | Withdrawn | Initiated by the client | GMP Site Approved |
| 4 | STATIM PHARMACEUTICALS LTD | 1289 | Vancocin CP 500 | | Foreign | Vancomycin Hydrochloride | one vial contains vancomycin hydrochloride… | 7116 | Injection | INTRAVENOUS | 24 months | a 10ml size vial sealed with a rubber stopper and… | J01XA | Antibacterials for systemic use:… | Eli Lilly and Company | 16ch.Des Conquelicots P.O Box 580 CH-1214… | moodleyan@lilly.com | VIANEX S.A. /PLANT C | 16th Km Marathonos Avenue, 15351 Pallini, Attica,… | Suspended | Regulatory decision | GMP Site is Invalid |
| 5 | PAN PHARMACEUTICALS LTD | 1601 | Emadine Eye Drops | Human | Foreign | Emadastine Difumarate | Emadastine Difumarate 0.5mg/ml (0.05%) | H2006/006 | Eye Drops, Solution | OPHTHALMIC | 30 months | Clear, colourless solution | S01GX06 | emedastine | Novartis Pharma AG | Litchtstrasse 35, 4056 Basel, Switzerland | peris.kibandi@novartis.com | ALCON COUVREUR N.V | RIJKSWEG 14,PUURS, B-2870, BELGIUM | Withdrawn | Initiated by the client | GMP Site is Invalid |
| 6 | PRODIGY HEALTHCARE LTD-NAIROBI | 1844 | PHARMA-Q MORPHINE 10MG/ML | | Foreign | MORPHINE SULPHATE 10MG | 10MG/ML | 13501 | Injection | INTRAVENOUS | 24 months | CLEAR COLORLESS | N02AA | Opioid Analgesics: Natural opium alkaloids | Prodigy Pharmaceuticals Limited | 12221 | cathy.otieno@prodigypharma.co.ke | PHARMA-Q (PTY) LTD50 COMMANDO ROAD INDUSTRIA WEST… | PHARMA-Q (PTY) LTD50 COMMANDO ROANDUSTRIA WEST… | Suspended | Regulatory decision | GMP Site is Invalid |
| 7 | PRODIGY HEALTHCARE LTD-NAIROBI | 1852 | PHARMA -Q FENTANYL 100MCG/2ML | | Foreign | FENTANYL CITRATE | 50MCG/ML | 13489 | Injection | INTRAVENOUS | 24 months | CLEAR COLORLESS | N01AH | General Anesthetics: Opioidanesthetics | Prodigy Pharmaceuticals Limited | 12221 | cathy.otieno@prodigypharma.co.ke | Ciron Drugs & Pharmaceuticals pvt ltd | | Suspended | Regulatory decision | GMP Site is Invalid |
| 8 | PFIZER LABORATORIES LTD | 3005 | Salazopyrin EN 500 | | Foreign | Sulfasalazine | 500mg | H2000/070 | Tablet | ORAL | 60 months | Yellow-orange elliptical convex enteric-coated… | A07EC | Intestinal anti-inflammatory agents:… | Pfizer Laboratories Limited | 197 Lenana Road - Nairobi | epaphrodite.twahirwa@pfizer.com | PFIZER ITALIA S.R.L | 63100 | Withdrawn | Initiated by the client | GMP Site Approved |
| 9 | SANOFI AVENTIS KENYA LTD | 6026 | Paraflam tab | | Foreign | Ibuprofen 400mg + Paracetamol 325mg | Ibuprofen 400mg + Paracetamol 325mg | H2006/425 | Tablet | ORAL | 36 months | White elongated biconvex uncoated tablets with… | N02BG | Other analgesics and antipyretics | sanofi-aventis Kenya | P.O Box 20337 - 00200 Nairobi Kenya | josephine.kinyota@sanofi.com | MEDREICH (UNIT II) | NO. 49B, BOMMASANDRA INDUSTRIAL AREA, ANEKAL… | Withdrawn | Initiated by the client | GMP Site is Invalid |
| 10 | SANOFI AVENTIS KENYA LTD | 7308 | Tritazide 10mg/12.5mg tablet | | Foreign | Ramipril 10mg + Hydrochlorothiazide 12.5mg | Ramipril 10mg + Hydrochlorothiazide 12.5mg | 20819 | Tablet | ORAL | 36 months | Orange oblong biplanar tablets with score-line on… | C09BA | Agents acting on the renin-angiotensin system:… | sanofi-aventis Kenya | P.O Box 20337 - 00200 Nairobi Kenya | josephine.kinyota@sanofi.com | SANOFI AVENTIS S.P.A. | ROAD # 17-KM 22, 67019 SCOPPITO, L'AQUILA, ITALY | Withdrawn | Initiated by the client | GMP Site is Invalid |