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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 74Strides Pharma SA (Pty) Ltd

09 1Strides S.A. Pharmaceuticals (Pty) Ltd

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 (Pty) Ltd

17 10Actavis Pharma (Pty) Ltd

18 63Activo Health (Pty) Ltd

19 52Actor Pharma (Pty) Ltd

20 1Actor Pharma (Pty) Ltd.

21 1137Adcock Ingram Critical Care (Pty) Ltd

22 6Adcock Ingram Healthcare (Pty) Ltd

23 1406Adcock Ingram Limited

24 2Adven Pharma (Pty) Ltd

25 77Akacia Health Care (Pty) Ltd

26 22Alcon Laboratories (Sa) (Pty) Ltd

27 22Alliance Pharma (Pty) Ltd

28 93Alliance Pharmaceuticals

29 13Allied Drug Company

30 27Amgen South Africa (Pty) Ltd

31 3Ando Pharma (Pty) Ltd

32 53Arrow Pharma South Africa (Pty) Ltd

33 39Arya Pharma (Pty) Ltd

34 57Ascend Laboratories (Pty) Ltd

35 7Ascendis Pharma (Pty) Ltd

36 27Astellas Pharma (Pty) Ltd

37 1AstraZeneca Pharmaceuticals (Pty) Ltd

38 25Astral Pharma (Pty) Ltd

39 9Astrazeneca Pharmaceuticals (Pty) Ltd

40 3Astrazeneca Pharmaceuticals (Pty) Ltd - Bryanston

41 100Astrazeneca Pharmaceuticals (Pty) Ltd - Sunninghill

42 32Astrazeneca Pharmaceuticals (Pty) Ltd- Bryanston

43 2Astrazeneca Pharmaceuticals (Pty) Ltd- Sunninghill

44 55Aurobindo Pharma (Pty) Ltd

45 109Aurogen South Africa (Pty) Ltd

46 156Austell Laboratories (Pty) Ltd

47 5Austell Pharmaceuticals (Pty) Ltd

48 134Austell Pharmaceuticals (Pty) Ltd

49 54Axim Pharmaceuticals (Pty) Ltd

50 738B. Braun Medical (Pty) Ltd

51 1BEIGENE SOUTH AFRICA (PTY) LTD

52 91Baroque Pharmaceuticals (Pty) Ltd

53 4Barrs Pharmaceutical Industries (Pty) Ltd

54 10Baxter HealthCare South Africa (Pty) Ltd

55 74Baxter Healthcare South Africa (Pty) Ltd

56 189Bayer (Pty) Ltd

57 63Be Tabs Pharmaceuticals (Pty) Ltd

58 4Bennetts The Chemists (Pty) Ltd

59 218Biotech Laboratories (Pty) Ltd

60 3Bliss Pharmaceuticals

61 55Bodene (Pty) Ltd

62 153Boston Scientific (Pty) Ltd

63 6Brimpharm SA (Pty) Ltd

64 5Brimpharm Sa (Pty) Ltd

65 73Bristol-Myers Squibb (Pty) Ltd

66 12Brunel Laboratoria (Pty) Ltd

67 47Camox Pharmaceuticals (Pty) Ltd

68 33Caps Pharmaceuticals

69 1Cipla Life Sciences (Pty) Ltd

70 629Cipla Medpro (Pty) Ltd

71 6Cipla Medpro Manufacturing (Pty) Ltd

72 5Concord Food & Drug Distributors CC

73 3Curanto Pharma (Pty) Ltd

74 6Delfran (Pty) Ltd

75 51Dezzo Trading 392 (Pty) Limited T/A Indo Pharma

76 23Dezzo Trading 392 (Pty) Ltd

77 143Dr Reddy's Laboratories (Pty) Ltd

78 2Eco Pharmaceuticals (Pty) Ltd

79 11Eisai Pharmaceuticals Africa (Pty) Ltd

80 66Eli Lilly (SA) (Pty) Ltd

81 1Elttab Pharmaceuticals

82 33Emcure Pharmaceuticals South Africa (Pty) Ltd

83 2Encha Health (Pty) Ltd

84 93Equity Pharmaceuticals (Pty) Ltd

85 63Eurolab (Pty) Ltd

86 27F.D.C. SA (PTY) LTD

87 41Ferring (Pty) Ltd

88 89Forrester Pharma (Pty) Ltd

89 133Fresenius Kabi Manufacturing SA (Pty) Ltd

90 1051Fresenius Kabi SA (Pty) Ltd

91 1335Fresenius Kabi South Africa (Pty) Ltd

92 37Fresenius Medical Care SA (Pty) Ltd

93 21GE Healthcare (Pty) Ltd

94 17Galderma Laboratories South Africa (Pty) Ltd

95 14Gen-Eye (Pty) Ltd

96 13Gen-Eye (pty) Ltd

97 7Genop Healthcare (Pty) Ltd

98 5Gilead Sciences South Africa (Pty) Ltd

99 2GlaxoSmithKline Consumer Healthcare (Pty) Ltd

100 40GlaxoSmithKline Consumer Healthcare South Africa (Pty) Ltd

101 217GlaxoSmithKline South Africa (Pty) Limited

102 2GlaxoSmithKline South Africa Pty Ltd

103 129Glaxosmithkline South Africa (Pty) Ltd - Cape Town

104 53Glenmark Pharmaceuticals South Africa (Pty) Ltd

105 2Goldex 775 (Pty) Ltd

106 63Guerbet South Africa (Pty) Ltd

107 124Gulf Drug Company (Pty) Ltd

108 30H. Lundbeck (Pty) Ltd

109 7Henry Schein Dental Warehouse (Pty) Ltd

110 130Hetero Drugs South Africa (Pty) Ltd

111 1IPM South Africa NPC

112 4Imperial Market Access Healthcare SA (Pty) Ltd

113 152Ingelheim Pharmaceuticals (Pty) Ltd

114 1Ingwe Lifescience (Pty) Ltd

115 103Innovata Pharmaceuticals (Pty) Ltd

116 194Janssen Pharmaceutica (Pty) Ltd

117 198Johnson & Johnson (Pty) Ltd

118 32Jubilant Pharma SA (Pty) Ltd

119 6Juno Pharma SA (Pty) Ltd

120 11Kahma Biotech (Pty) Ltd

121 39Key Oncologics (Pty) Ltd

122 52Kiara Health (PTY) LTD

123 23LHC Pharmaceuticals (Pty) Ltd

124 4Lamar International (Pty) Ltd

125 7LeBasi Pharmaceuticals (Pty) Ltd

126 47LeBasi Pharmaceuticals CC

127 4Lebasi Pharmaceuticals (Pty) Ltd

128 18Lebasi Pharmaceuticals CC

129 68Litha Pharma (Pty) Ltd

130 2Litha Vaccines

131 1Loock Pharmaceuticals (Pty Ltd

132 1Loock Pharmaceuticals (Pty) Ltd

133 18MC Pharma (Pty) Ltd

134 3MDI HEALTHCARE CC

135 129MSD (Pty) Ltd

136 268Macleods Pharmaceuticals SA (Pty) Ltd

137 28Mallinckrodt (Pty) Ltd

138 8Meda Pharma South Africa (Pty) Ltd

139 3Medchem Pharmaceuticals

140 7Medi Challenge

141 77Medicine Developers International CC

142 15Medicine Developers International Healthcare cc

143 17Medivision (Pty) Ltd

144 3Medpro Pharmaceutica (Pty) Ltd

145 1Medwich Pharma (Pty) Ltd

146 4Mentholatum South Africa (Pty) Ltd

147 115Merck (Pty) Ltd

148 1MeyerZall Laboratories (Pty) Ltd

149 18Micro Healthcare

150 2Mirren (Pty) Ltd

151 41Mundipharma (Pty) Ltd

152 256Mylan (Pty) Ltd

153 79NTP Radioisotopes (Pty) Ltd

154 21National Bioproducts Institute (NPC)

155 6Norgine (Pty) Ltd

156 64Novagen Pharma (Pty) Ltd

157 329Novartis South Africa (Pty) Ltd

158 59Novo Nordisk (Pty) Ltd

159 6ORTHOMEDICS PHARMACEUTICALS (PTY) LTD

160 24Octapharma SA (Pty) Ltd

161 98Oethmaan Biosims (Pty) Ltd

162 2Omnimed

163 17Opella Healthcare South Africa (Pty) Ltd

164 3Opus Pharmaceuticals (Pty) Limited

165 1Orchid Pharmaceuticals SA (Pty) Ltd

166 114Organon South Africa (Pty) Ltd

167 271Pfizer Laboratories (Pty) Ltd

168 328Pharma Dynamics (Pty) Ltd

169 49Pharma Q (Pty) Ltd

170 48Pharma-Q Holdings (Pty) Ltd

171 9Pharmaceutical Contractors (Pty) Ltd

172 44Pharmaceutical Enterprises (Pty) Ltd

173 27Pharmachemie (Pty) Ltd

174 2Pharmacia South Africa (Pty) Ltd

175 66Pharmaco Distribution (Pty) Ltd

176 44Pharmacorp (Pty) Ltd

177 7Pharmafrica (Pty) Ltd

178 15Pharmaplan (Pty) Ltd

179 12Pharmascript Pharmaceuticals Ltd

180 6Phyto OTC Health (Pty) Ltd

181 6Pierre Fabre South Africa (Pty) Ltd

182 7Piramal Critical Care South Africa (Pty) Ltd

183 2Portfolio Laboratories (Pty) Ltd

184 19Procter & Gamble SA (Pty) Ltd

185 4RX Medicals (Pty) Ltd

186 465Ranbaxy Pharmaceuticals (Pty) Ltd

187 89Ranbaxy S.A (Pty) Ltd

188 33Reckitt Benckiser Pharmaceuticals (Pty) Ltd

189 5Resmed Healthcare

190 1Roche Products (Pty) Ltd

191 144Roche Products (Pty) Ltd

192 22Ruby Pharmaceuticals (Pty) Ltd

193 2SCP Pharmaceuticals (Pty) Ltd

194 10SMART PHARMACEUTICALS (PTY) LTD

195 33Safeline Pharmaceuticals (Pty) Ltd

196 605Sandoz SA (Pty) Ltd

197 71Sandoz SA Pty Ltd

198 22Schering-Plough (Pty) Ltd - (Site1)

199 24Sekpharma (Pty) Ltd

200 126Servier Laboratories S.A. (Pty) Ltd

201 4Shanur Healthcare (Pty) Ltd

202 8Smith & Nephew Pharmaceuticals (Pty) Limited

203 30Soflens (Pty) Ltd

204 8Sonke Pharmaceuticals (Pty) Ltd

205 6South African Vaccine producers (PTY) LTD

206 3Spear Pharmaceuticals

207 75Specpharm (Pty) Ltd

208 2Specpharm Holdings (Pty) Ltd

209 2Sun Pharmaceuticals SA (Pty) Ltd

210 45Takeda (Pty) Ltd

211 5Technikon Laboratories (Pty) Ltd

212 6Tema Medical (Pty) Ltd

213 212Teva Pharmaceuticals (Pty) Ltd

214 5The Biovac Institute

215 57Thebe Medicare

216 16Thebe Medicare (Pty) Ltd

217 184Trinity Pharma (Pty) Ltd

218 11Umsebe Healthcare

219 57Unichem SA (Pty) Ltd

220 117Unicorn Pharmaceuticals (Pty) Ltd

221 70Unimed Healthcare (Pty) Ltd

222 103Viatris Healthcare (Pty) Ltd

223 65Viatris South Africa (Pty) Ltd

224 14Watson Pharma No. 1 (Pty) Ltd

225 22Western Province Blood Transfusion Service

226 5Wyeth Consumer Healthcare

227 114Xixia Pharmaceuticals (Pty) Ltd

228 29Zentiva South Africa (Pty) Ltd-Midrand

229 4Zimbili Pharma CC

230 191Zydus Healthcare SA (Pty) Ltd

231 97iNova Pharmaceuticals (Pty) Ltd

232 10iPharma (Pty) Ltd

233 18iThemba LABS

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PharmaCompass

01

AACR Annual meeting
Not Confirmed
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AACR Annual meeting
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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02

AACR Annual meeting
Not Confirmed
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AACR Annual meeting
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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03

AACR Annual meeting
Not Confirmed
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AACR Annual meeting
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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04

AACR Annual meeting
Not Confirmed
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AACR Annual meeting
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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05

AACR Annual meeting
Not Confirmed
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AACR Annual meeting
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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06

AACR Annual meeting
Not Confirmed
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AACR Annual meeting
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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07

AACR Annual meeting
Not Confirmed
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AACR Annual meeting
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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08

AACR Annual meeting
Not Confirmed
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AACR Annual meeting
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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09

AACR Annual meeting
Not Confirmed
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AACR Annual meeting
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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10

AACR Annual meeting
Not Confirmed
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AACR Annual meeting
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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