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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 62AbbVie (Pty) Ltd

05 1Abbvie (Pty) Ltd

06 4Allergan Pharmaceuticals (Pty) Ltd

07 1354Pharmacare Limited, Woodmead

08 63M South Africa (Pty) Ltd

09 9AHN Pharma (Pty) Limited

10 8APOTHECON LABS cc

11 97Abbott Laboratories SA (Pty) Ltd

12 47Abex Pharmaceutica (Pty) Ltd

13 174Accord Healthcare (Pty) Ltd

14 142Acino Pharma (Pty) Ltd

15 10Actavis Pharma (Pty) Ltd

16 63Activo Health (Pty) Ltd

17 1Actor Pharma

18 52Actor Pharma (Pty) Ltd

19 1137Adcock Ingram Critical Care (Pty) Ltd

20 6Adcock Ingram Healthcare (Pty) Ltd

21 1406Adcock Ingram Limited

22 2Adven Pharma (Pty) Ltd

23 77Akacia Health Care (Pty) Ltd

24 22Alcon Laboratories (Sa) (Pty) Ltd

25 22Alliance Pharma (Pty) Ltd

26 93Alliance Pharmaceuticals

27 13Allied Drug Company

28 27Amgen South Africa (Pty) Ltd

29 3Ando Pharma (Pty) Ltd

30 53Arrow Pharma South Africa (Pty) Ltd

31 39Arya Pharma Pty Ltd

32 57Ascend Laboratories (Pty) Ltd

33 7Ascendis Pharma (Pty) Ltd

34 27Astellas Pharma (Pty) Ltd

35 1AstraZeneca Pharmaceuticals (Pty) Ltd

36 25Astral Pharma (Pty) Ltd

37 9Astrazeneca Pharmaceuticals (Pty) Ltd

38 3Astrazeneca Pharmaceuticals (Pty) Ltd - Bryanston

39 100Astrazeneca Pharmaceuticals (Pty) Ltd - Sunninghill

40 32Astrazeneca Pharmaceuticals (Pty) Ltd- Bryanston

41 2Astrazeneca Pharmaceuticals (Pty) Ltd- Sunninghill

42 55Aurobindo Pharma (Pty) Ltd

43 109Aurogen South Africa (Pty) Ltd

44 156Austell Laboratories (Pty) Ltd

45 5Austell Pharmaceuticals (Pty) Ltd

46 134Austell Pharmaceuticals (Pty) Ltd

47 54Axim Pharmaceuticals (Pty) Ltd

48 738B. Braun Medical (Pty) Ltd

49 1BEIGENE SOUTH AFRICA (PTY) LTD

50 91Baroque Pharmaceuticals (Pty) Ltd

51 4Barrs Pharmaceutical Industries (Pty) Ltd

52 10Baxter HealthCare South Africa (Pty) Ltd

53 74Baxter Healthcare South Africa (Pty) Ltd

54 189Bayer (Pty) Ltd

55 63Be Tabs Pharmaceuticals (Pty) Ltd

56 4Bennetts The Chemists (Pty) Ltd

57 218Biotech Laboratories (Pty) Ltd

58 3Bliss Pharmaceuticals

59 55Bodene (Pty) Ltd

60 153Boston Scientific (Pty) Ltd

61 6Brimpharm SA (Pty) Ltd

62 5Brimpharm Sa (Pty) Ltd

63 73Bristol-Myers Squibb (Pty) Ltd

64 12Brunel Laboratoria (Pty) Ltd

65 47Camox Pharmaceuticals (Pty) Ltd

66 33Caps Pharmaceuticals

67 1Cipla Life Sciences (Pty) Ltd

68 629Cipla Medpro (Pty) Ltd

69 6Cipla Medpro Manufacturing (Pty) Ltd

70 5Concord Food & Drug Distributors CC

71 3Curanto Pharma (Pty) Ltd

72 6Delfran (Pty) Ltd

73 51Dezzo Trading 392 (Pty) Limited T/A Indo Pharma

74 23Dezzo Trading 392 (Pty) Ltd

75 143Dr Reddy's Laboratories (Pty) Ltd

76 2Eco Pharmaceuticals (Pty) Ltd

77 11Eisai Pharmaceuticals Africa (Pty) Ltd

78 66Eli Lilly (SA) (Pty) Ltd

79 1Elttab Pharmaceuticals

80 33Emcure Pharmaceuticals South Africa (Pty) Ltd

81 2Encha Health (Pty) Ltd

82 93Equity Pharmaceuticals (Pty) Ltd

83 63Eurolab (Pty) Ltd

84 27F.D.C. SA (PTY) LTD

85 41Ferring (Pty) Ltd

86 89Forrester Pharma (Pty) Ltd

87 133Fresenius Kabi Manufacturing SA (Pty) Ltd

88 1051Fresenius Kabi SA (Pty) Ltd

89 1335Fresenius Kabi South Africa (Pty) Ltd

90 37Fresenius Medical Care SA (Pty) Ltd

91 21GE Healthcare (Pty) Ltd

92 17Galderma Laboratories South Africa (Pty) Ltd

93 14Gen-Eye (Pty) Ltd

94 13Gen-Eye (pty) Ltd

95 7Genop Healthcare (Pty) Ltd

96 5Gilead Sciences South Africa (Pty) Ltd

97 2GlaxoSmithKline Consumer Healthcare (Pty) Ltd

98 40GlaxoSmithKline Consumer Healthcare South Africa (Pty) Ltd

99 217GlaxoSmithKline South Africa (Pty) Limited

100 2GlaxoSmithKline South Africa Pty Ltd

101 129Glaxosmithkline South Africa (Pty) Ltd - Cape Town

102 53Glenmark Pharmaceuticals South Africa (Pty) Ltd

103 2Goldex 775 (Pty) Ltd

104 63Guerbet South Africa (Pty) Ltd

105 124Gulf Drug Company (Pty) Ltd

106 30H. Lundbeck (Pty) Ltd

107 7Henry Schein Dental Warehouse (Pty) Ltd

108 130Hetero Drugs South Africa (Pty) Ltd

109 1IPM South Africa NPC

110 4Imperial Market Access Healthcare SA (Pty) Ltd

111 152Ingelheim Pharmaceuticals (Pty) Ltd

112 1Ingwe Lifescience (Pty) Ltd

113 103Innovata Pharmaceuticals (Pty) Ltd

114 194Janssen Pharmaceutica (Pty) Ltd

115 198Johnson & Johnson (Pty) Ltd

116 32Jubilant Pharma SA (Pty) Ltd

117 6Juno Pharma SA (Pty) Ltd

118 11Kahma Biotech (Pty) Ltd

119 39Key Oncologics (Pty) Ltd

120 52Kiara Health (PTY) LTD

121 23LHC Pharmaceuticals (Pty) Ltd

122 4Lamar International (Pty) Ltd

123 7LeBasi Pharmaceuticals (Pty) Ltd

124 47LeBasi Pharmaceuticals CC

125 4Lebasi Pharmaceuticals (Pty) Ltd

126 18Lebasi Pharmaceuticals CC

127 68Litha Pharma (Pty) Ltd

128 2Litha Vaccines

129 1Loock Pharmaceuticals (Pty Ltd

130 1Loock Pharmaceuticals (Pty) Ltd

131 18MC Pharma (Pty) Ltd

132 3MDI HEALTHCARE CC

133 129MSD (Pty) Ltd

134 268Macleods Pharmaceuticals SA (Pty) Ltd

135 28Mallinckrodt (Pty) Ltd

136 8Meda Pharma South Africa (Pty) Ltd

137 3Medchem Pharmaceuticals

138 7Medi Challenge

139 77Medicine Developers International CC

140 15Medicine Developers International Healthcare cc

141 17Medivision (Pty) Ltd

142 3Medpro Pharmaceutica (Pty) Ltd

143 1Medwich Pharma (Pty) Ltd

144 4Mentholatum South Africa (Pty) Ltd

145 115Merck (Pty) Ltd

146 1MeyerZall Laboratories (Pty) Ltd

147 18Micro Healthcare

148 2Mirren (Pty) Ltd

149 41Mundipharma (Pty) Ltd

150 256Mylan (Pty) Ltd

151 79NTP Radioisotopes (Pty) Ltd

152 21National Bioproducts Institute (NPC)

153 6Norgine (Pty) Ltd

154 64Novagen Pharma (Pty) Ltd

155 329Novartis South Africa (Pty) Ltd

156 59Novo Nordisk (Pty) Ltd

157 6ORTHOMEDICS PHARMACEUTICALS (PTY) LTD

158 24Octapharma SA (Pty) Ltd

159 98Oethmaan Biosims (Pty) Ltd

160 2Omnimed

161 17Opella Healthcare South Africa (Pty) Ltd

162 3Opus Pharmaceuticals (Pty) Limited

163 1Orchid Pharmaceuticals SA (Pty) Ltd

164 114Organon South Africa (Pty) Ltd

165 271Pfizer Laboratories (Pty) Ltd

166 328Pharma Dynamics (Pty) Ltd

167 49Pharma Q (Pty) Ltd

168 48Pharma-Q Holdings (Pty) Ltd

169 9Pharmaceutical Contractors (Pty) Ltd

170 44Pharmaceutical Enterprises (Pty) Ltd

171 27Pharmachemie (Pty) Ltd

172 2Pharmacia South Africa (Pty) Ltd

173 66Pharmaco Distribution (Pty) Ltd

174 44Pharmacorp (Pty) Ltd

175 7Pharmafrica (Pty) Ltd

176 15Pharmaplan (Pty) Ltd

177 12Pharmascript Pharmaceuticals Ltd

178 6Phyto OTC Health (Pty) Ltd

179 6Pierre Fabre South Africa (Pty) Ltd

180 7Piramal Critical Care South Africa (Pty) Ltd

181 2Portfolio Laboratories (Pty) Ltd

182 19Procter & Gamble SA (Pty) Ltd

183 4RX Medicals (Pty) Ltd

184 465Ranbaxy Pharmaceuticals (Pty) Ltd

185 89Ranbaxy S.A (Pty) Ltd

186 33Reckitt Benckiser Pharmaceuticals (Pty) Ltd

187 5Resmed Healthcare

188 1Roche Products (Pty) Ltd

189 144Roche Products (Pty) Ltd

190 22Ruby Pharmaceuticals (Pty) Ltd

191 2SCP Pharmaceuticals (Pty) Ltd

192 10SMART PHARMACEUTICALS (PTY) LTD

193 33Safeline Pharmaceuticals (Pty) Ltd

194 605Sandoz SA (Pty) Ltd

195 71Sandoz SA Pty Ltd

196 22Schering-Plough (Pty) Ltd - (Site1)

197 24Sekpharma (Pty) Ltd

198 126Servier Laboratories S.A. (Pty) Ltd

199 4Shanur Healthcare (Pty) Ltd

200 8Smith & Nephew Pharmaceuticals (Pty) Limited

201 30Soflens (Pty) Ltd

202 8Sonke Pharmaceuticals (Pty) Ltd

203 6South African Vaccine producers (PTY) LTD

204 3Spear Pharmaceuticals

205 75Specpharm (Pty) Ltd

206 2Specpharm Holdings (Pty) Ltd

207 2Sun Pharmaceuticals SA (Pty) Ltd

208 45Takeda (Pty) Ltd

209 5Technikon Laboratories (Pty) Ltd

210 6Tema Medical (Pty) Ltd

211 212Teva Pharmaceuticals (Pty) Ltd

212 5The Biovac Institute

213 57Thebe Medicare

214 16Thebe Medicare (Pty) Ltd

215 184Trinity Pharma (Pty) Ltd

216 11Umsebe Healthcare

217 57Unichem SA (Pty) Ltd

218 117Unicorn Pharmaceuticals (Pty) Ltd

219 70Unimed Healthcare (Pty) Ltd

220 103Viatris Healthcare (Pty) Ltd

221 65Viatris South Africa (Pty) Ltd

222 14Watson Pharma No. 1 (Pty) Ltd

223 22Western Province Blood Transfusion Service

224 5Wyeth Consumer Healthcare

225 114Xixia Pharmaceuticals (Pty) Ltd

226 29Zentiva South Africa (Pty) Ltd-Midrand

227 4Zimbili Pharma CC

228 191Zydus Healthcare SA (Pty) Ltd

229 97iNova Pharmaceuticals (Pty) Ltd

230 10iPharma (Pty) Ltd

231 18iThemba LABS

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PharmaCompass

01

Hospitalar
Not Confirmed
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Hospitalar
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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02

Hospitalar
Not Confirmed
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Hospitalar
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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03

Hospitalar
Not Confirmed
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Hospitalar
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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04

Hospitalar
Not Confirmed
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Hospitalar
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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05

Hospitalar
Not Confirmed
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Hospitalar
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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06

Hospitalar
Not Confirmed
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Hospitalar
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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07

Hospitalar
Not Confirmed
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Hospitalar
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

Hospitalar
Not Confirmed
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Hospitalar
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

Hospitalar
Not Confirmed
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Hospitalar
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

Hospitalar
Not Confirmed
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Hospitalar
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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