| 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| Boehringer Ingelheim Pharma GmbH & Co. KG, | 173 Binger Strasse, 55216, Ingelheim am Rhein,… | Withdrawn | Initiated by the client | GMP Site is Invalid |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 MBH | SALZBERGSTR. 96, A-6067 ABSAM, AUSTRIA | Withdrawn | Initiated by the client | GMP Site is Invalid |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Ingelheim am Rhein Germany | info@boehringer-ingelheim.de | LABORATOIRE UNITHER | 80084 AMIENS CEDEX, FRANCE | Withdrawn | Initiated by the client | GMP Site is Invalid |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| prijli@menarini.it | A. Menarini Manufacturing Logistics and Services… | Via Campo di Pile, 67100 L Aquila Italy | Withdrawn | Initiated by the client | GMP Site Approved |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 | 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 |
| 6 | SURGIPHARM LTD | 1133 | Mobic 15 mg/1.5 ml Ampoules | Human | Foreign | Meloxicam | 15 mg/1,5 ml | 15127; H2004/004 | Solution For Injection | INTRAMUSCULAR | 36 months | Clear yellow solution with a green tinge,… | M01AC | Non-steroidal… | Boehringer Ingelheim international GmbH | Binger StraBe 173 55216 Ingelheim am Rhein Germany | info@boehringer-ingelheim.de | BOEHRINGER INGELHEIM ESPANA S.A | PRAT DE LA RIBA 50, 08174 SANT CUGAT DEL VALLES,… | Withdrawn | Initiated by the client | GMP Site is Invalid |
| 7 | PHILLIPS THERAPEUTICS LIMITED | 1136 | SCHERIPROCT | | Foreign | Prednisolone hexanoate / Cinchocain HCl | 1 suppository contains: Prednisolone caproate 1.3… | 4125 | Suppository | RECTAL | 30 Days | 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 |
| 8 | 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 |
| 9 | 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 Days | 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 |
| 10 | 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 |