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Drug Approvals in South Africa

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01 4Genzyme Biopharmaceuticals SA (Pty) Ltd

02 369Sanofi Aventis South Africa (Pty) Ltd

03 33Winthrop Pharmaceuticals (Pty) Ltd

04 61AbbVie (Pty) Ltd

05 1AbbVie Inc

06 1Abbvie (Pty) Ltd

07 4Allergan Pharmaceuticals (Pty) Ltd

08 4Aspen Pharmacare Holdings

09 1350Pharmacare Limited, Woodmead

10 63M South Africa (Pty) Ltd

11 9AHN Pharma (Pty) Limited

12 8APOTHECON LABS cc

13 97Abbott Laboratories SA (Pty) Ltd

14 47Abex Pharmaceutica (Pty) Ltd

15 174Accord Healthcare (Pty) Ltd

16 142Acino Pharma

17 10Actavis Pharma (Pty) Ltd

18 63Activo Health (Pty) Ltd

19 1Actor Pharma

20 52Actor Pharma (Pty) Ltd

21 42Adcock Ingram

22 1120Adcock Ingram Critical Care (Pty) Ltd

23 5Adcock Ingram Healthcare (Pty) Ltd

24 1382Adcock Ingram Limited

25 2Adven Pharma (Pty) Ltd

26 77Akacia Health Care (Pty) Ltd

27 22Alcon Laboratories (Sa) (Pty) Ltd

28 22Alliance Pharma (Pty) Ltd

29 93Alliance Pharmaceuticals

30 13Allied Drug Company

31 6Amgen Inc

32 21Amgen South Africa (Pty) Ltd

33 3Ando Pharma (Pty) Ltd

34 53Arrow Pharma South Africa (Pty) Ltd

35 39Arya Pharma Pty Ltd

36 55Ascend Laboratories (Pty) Ltd

37 2Ascend Labs

38 7Ascendis Pharma

39 27Astellas Pharma (Pty) Ltd

40 2AstraZeneca

41 1AstraZeneca Pharmaceuticals (Pty) Ltd

42 25Astral Pharma (Pty) Ltd

43 9Astrazeneca Pharmaceuticals (Pty) Ltd

44 3Astrazeneca Pharmaceuticals (Pty) Ltd - Bryanston

45 100Astrazeneca Pharmaceuticals (Pty) Ltd - Sunninghill

46 30Astrazeneca Pharmaceuticals (Pty) Ltd- Bryanston

47 2Astrazeneca Pharmaceuticals (Pty) Ltd- Sunninghill

48 55Aurobindo Pharma (Pty) Ltd

49 109Aurogen South Africa (Pty) Ltd

50 4Austell Laboratories

51 156Austell Laboratories (Pty) Ltd

52 135Austell Pharmaceuticals (Pty) Ltd

53 54Axim Pharmaceuticals (Pty) Ltd

54 22B. Braun Medical

55 716B. Braun Medical (Pty) Ltd

56 91Baroque Pharmaceuticals (Pty) Ltd

57 4Barrs Pharmaceutical Industries (Pty) Ltd

58 1Bausch & Lomb Incorporated

59 84Baxter Healthcare Corporation

60 184Bayer (Pty) Ltd

61 5Bayer AG

62 63Be Tabs Pharmaceuticals (Pty) Ltd

63 1BeiGene

64 4Bennetts The Chemists (Pty) Ltd

65 214Biotech Laboratories (Pty) Ltd

66 4Biotech Laboratories Pty Ltd

67 3Bliss Pharmaceuticals

68 55Bodene (Pty) Ltd

69 153Boston Scientific (Pty) Ltd

70 6Brimpharm SA (Pty) Ltd

71 5Brimpharm Sa (Pty) Ltd

72 73Bristol-Myers Squibb (Pty) Ltd

73 1Brunel Laboratoria

74 11Brunel Laboratoria (Pty) Ltd

75 47Camox Pharmaceuticals (Pty) Ltd

76 33Caps Pharmaceuticals

77 1Cipla Life Sciences (Pty) Ltd

78 619Cipla Medpro (Pty) Ltd

79 16Cipla Medpro South Africa

80 1Clinigen Group

81 5Concord Food & Drug Distributors CC

82 3Curanto Pharma (Pty) Ltd

83 2Delfran

84 4Delfran (Pty) Ltd

85 51Dezzo Trading 392 (Pty) Limited T/A Indo Pharma

86 23Dezzo Trading 392 (Pty) Ltd

87 143Dr Reddy's Laboratories (Pty) Ltd

88 2Eco Pharmaceuticals (Pty) Ltd

89 11Eisai

90 66Eli Lilly (SA) (Pty) Ltd

91 1Elttab Pharmaceuticals

92 33Emcure Pharmaceuticals South Africa (Pty) Ltd

93 2Encha Health (Pty) Ltd

94 92Equity Pharmaceuticals (Pty) Ltd

95 2Eurolab

96 61Eurolab (Pty) Ltd

97 24F.D.C. SA (PTY) LTD

98 3FDC

99 36Ferring (Pty) Ltd

100 5Ferring Pharmaceuticals

101 89Forrester Pharma (Pty) Ltd

102 133Fresenius Kabi Manufacturing SA (Pty) Ltd

103 1051Fresenius Kabi SA (Pty) Ltd

104 1313Fresenius Kabi South Africa (Pty) Ltd

105 37Fresenius Medical Care SA (Pty) Ltd

106 22Fresenius SE & Co. KGaA

107 21GE Healthcare (Pty) Ltd

108 2GLAXOSMITHKLINE CONSUMER HEALTHCARE INC

109 17Galderma Laboratories South Africa (Pty) Ltd

110 14Gen-Eye (Pty) Ltd

111 13Gen-Eye (pty) Ltd

112 7Genop Healthcare (Pty) Ltd

113 5Gilead Sciences South Africa (Pty) Ltd

114 2GlaxoSmithKline

115 40GlaxoSmithKline Consumer Healthcare South Africa (Pty) Ltd

116 217GlaxoSmithKline South Africa (Pty) Limited

117 129Glaxosmithkline South Africa (Pty) Ltd - Cape Town

118 2Glenmark Pharmaceuticals

119 51Glenmark Pharmaceuticals South Africa (Pty) Ltd

120 2Goldex 775 (Pty) Ltd

121 63Guerbet South Africa (Pty) Ltd

122 124Gulf Drug Company (Pty) Ltd

123 30H. Lundbeck (Pty) Ltd

124 7Henry Schein Dental Warehouse (Pty) Ltd

125 1Hetero Drugs

126 129Hetero Drugs South Africa (Pty) Ltd

127 2INNOVATA PHARMACEUTICALS

128 1IPM South Africa NPC

129 4Imperial Market Access Healthcare SA (Pty) Ltd

130 152Ingelheim Pharmaceuticals (Pty) Ltd

131 1Ingwe Lifescience (Pty) Ltd

132 101Innovata Pharmaceuticals (Pty) Ltd

133 185Janssen Pharmaceutica (Pty) Ltd

134 198Johnson & Johnson (Pty) Ltd

135 9Johnson & Johnson Innovative Medicine

136 1Jubilant Generics

137 31Jubilant Pharma SA (Pty) Ltd

138 6Juno Pharmaceuticals Pty Ltd

139 11Kahma Biotech (Pty) Ltd

140 39Key Oncologics (Pty) Ltd

141 52Kiara Health (PTY) LTD

142 23LHC Pharmaceuticals (Pty) Ltd

143 4Lamar International

144 58LeBasi Pharmaceuticals CC

145 18Lebasi Pharmaceuticals CC

146 68Litha Pharma (Pty) Ltd

147 2Litha Vaccines

148 1Loock Pharmaceuticals (Pty Ltd

149 1Loock Pharmaceuticals (Pty) Ltd

150 18MC Pharma (Pty) Ltd

151 3MDI HEALTHCARE CC

152 129MSD (Pty) Ltd

153 268Macleods Pharmaceuticals SA (Pty) Ltd

154 28Mallinckrodt (Pty) Ltd

155 8Meda Pharma South Africa (Pty) Ltd

156 3Medchem Pharmaceuticals

157 7Medi Challenge

158 77Medicine Developers International CC

159 15Medicine Developers International Healthcare cc

160 17Medivision (Pty) Ltd

161 3Medpro Pharmaceutica (Pty) Ltd

162 1Medwich Pharma (Pty) Ltd

163 4Mentholatum South Africa (Pty) Ltd

164 114Merck (Pty) Ltd

165 1Merck Group

166 1MeyerZall Laboratories (Pty) Ltd

167 18Micro Healthcare

168 2Mirren (Pty) Ltd

169 41Mundipharma (Pty) Ltd

170 249Mylan (Pty) Ltd

171 78NTP Radioisotopes (Pty) Ltd

172 1NTP Radioisotopes Soc Ltd

173 6National Bioproducts Institute

174 15National Bioproducts Institute (NPC)

175 6Norgine (Pty) Ltd

176 1Novagen Pharma

177 63Novagen Pharma (Pty) Ltd

178 323Novartis

179 6Novartis Pharmaceuticals Corporation

180 59Novo Nordisk (Pty) Ltd

181 1ORGANON CANADA

182 6ORTHOMEDICS PHARMACEUTICALS (PTY) LTD

183 2Octapharma

184 22Octapharma SA (Pty) Ltd

185 2Oethmaan Biosims

186 96Oethmaan Biosims (Pty) Ltd

187 2Omnimed

188 17Opella Healthcare Group

189 3Opus Pharmaceuticals (Pty) Limited

190 1Orchid Pharmaceuticals SA (Pty) Ltd

191 113Organon

192 271Pfizer Laboratories (Pty) Ltd

193 5Pharma Dynamics

194 323Pharma Dynamics (Pty) Ltd

195 49Pharma Q (Pty) Ltd

196 48Pharma-Q

197 9Pharmaceutical Contractors (Pty) Ltd

198 44Pharmaceutical Enterprises (Pty) Ltd

199 27Pharmachemie

200 2Pharmacia South Africa (Pty) Ltd

201 66Pharmaco Distribution (Pty) Ltd

202 44Pharmacorp

203 7Pharmafrica (Pty) Ltd

204 15Pharmaplan (Pty) Ltd

205 12Pharmascript Pharmaceuticals Ltd

206 6Phyto OTC Health (Pty) Ltd

207 6Pierre Fabre South Africa (Pty) Ltd

208 7Piramal Critical Care South Africa (Pty) Ltd

209 2Portfolio Laboratories (Pty) Ltd

210 19Procter & Gamble SA (Pty) Ltd

211 4RX Medicals (Pty) Ltd

212 464Ranbaxy Pharmaceuticals (Pty) Ltd

213 89Ranbaxy S.A (Pty) Ltd

214 33Reckitt Benckiser Pharmaceuticals (Pty) Ltd

215 5Resmed Healthcare

216 145Roche Products (Pty) Ltd

217 22Ruby Pharmaceuticals (Pty) Ltd

218 2SCP Pharmaceuticals (Pty) Ltd

219 10SMART PHARMACEUTICALS (PTY) LTD

220 2Safeline Pharmaceuticals

221 31Safeline Pharmaceuticals (Pty) Ltd

222 605Sandoz SA (Pty) Ltd

223 71Sandoz SA Pty Ltd

224 22Schering-Plough (Pty) Ltd - (Site1)

225 24Sekpharma (Pty) Ltd

226 126Servier

227 4Shanur Healthcare (Pty) Ltd

228 8Smith & Nephew Pharmaceuticals (Pty) Limited

229 29Soflens (Pty) Ltd

230 8Sonke Pharmaceuticals (Pty) Ltd

231 6South African Vaccine Producers

232 3Spear Pharmaceuticals

233 75Specpharm (Pty) Ltd

234 2Specpharm Holdings (Pty) Ltd

235 1Sun Pharmaceutical Industries Limited

236 2Sun Pharmaceuticals SA (Pty) Ltd

237 45Takeda (Pty) Ltd

238 5Technikon Laboratories (Pty) Ltd

239 6Tema Medical (Pty) Ltd

240 212Teva Pharmaceuticals (Pty) Ltd

241 5The Biovac Institute

242 2Thebe

243 55Thebe Medicare

244 16Thebe Medicare (Pty) Ltd

245 178Trinity Pharma (Pty) Ltd

246 6Trinity Pharmaceuticals

247 11Umsebe Healthcare

248 57Unichem SA (Pty) Ltd

249 117Unicorn Pharmaceuticals (Pty) Ltd

250 5Unimed Healthcare

251 65Unimed Healthcare (Pty) Ltd

252 72Viatris

253 103Viatris Healthcare (Pty) Ltd

254 14Watson Pharma No. 1 (Pty) Ltd

255 22Western Province Blood Transfusion Service

256 5Wyeth Consumer Healthcare

257 114Xixia Pharmaceuticals (Pty) Ltd

258 29Zentiva

259 4Zimbili Pharma CC

260 191Zydus Healthcare SA (Pty) Ltd

261 97iNova Pharmaceuticals (Pty) Ltd

262 10iPharma (Pty) Ltd

263 18iThemba LABS

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PharmaCompass

01

DIA 2025
Not Confirmed
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DIA 2025
Not Confirmed

Adrenaline

Brand Name : Ubistesin Forte

Dosage Form : INJ

Dosage Strength : 0.01mg/ml

Packaging : 50X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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02

DIA 2025
Not Confirmed
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DIA 2025
Not Confirmed

Lidocaine hydrochloride

Brand Name : Xylestesin-A

Dosage Form : INJ

Dosage Strength : 20mg/ml

Packaging : 50X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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03

DIA 2025
Not Confirmed
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DIA 2025
Not Confirmed

Articaine hydrochloride

Brand Name : Ubistesin

Dosage Form : INJ

Dosage Strength : 40mg/ml

Packaging : 50X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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04

DIA 2025
Not Confirmed
arrow
arrow
DIA 2025
Not Confirmed

Articaine hydrochloride

Brand Name : Ubistesin Forte

Dosage Form : INJ

Dosage Strength : 40mg/ml

Packaging : 50X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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05

DIA 2025
Not Confirmed
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DIA 2025
Not Confirmed

Adrenaline

Brand Name : Xylestesin-A

Dosage Form : INJ

Dosage Strength : 0.012mg/ml

Packaging : 50X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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06

DIA 2025
Not Confirmed
arrow
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DIA 2025
Not Confirmed

Adrenaline

Brand Name : Ubistesin

Dosage Form : INJ

Dosage Strength : 0.01mg/ml

Packaging : 50X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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07

DIA 2025
Not Confirmed
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DIA 2025
Not Confirmed

Rosuvastatin

Brand Name : Lypstaplus 20 mg/10 mg

Dosage Form : Tab

Dosage Strength : 20mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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08

DIA 2025
Not Confirmed
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DIA 2025
Not Confirmed

Rosuvastatin

Brand Name : Lypstaplus 10 mg/10 mg

Dosage Form : Tab

Dosage Strength : 10mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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09

DIA 2025
Not Confirmed
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DIA 2025
Not Confirmed

Ezetimibe

Brand Name : Lypstaplus 20 mg/10 mg

Dosage Form : Tab

Dosage Strength : 10mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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10

DIA 2025
Not Confirmed
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DIA 2025
Not Confirmed

Ezetimibe

Brand Name : Lypstaplus 10 mg/10 mg

Dosage Form : Tab

Dosage Strength : 10mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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