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Drug Approvals in South Africa

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01 4Genzyme Biopharmaceuticals SA (Pty) Ltd

02 372Sanofi Aventis South Africa (Pty) Ltd

03 33Winthrop Pharmaceuticals (Pty) Ltd

04 65AbbVie (Pty) Ltd

05 1Abbvie (Pty) Ltd

06 4Allergan Pharmaceuticals (Pty) Ltd

07 1Aspen Pharmacare Holdings

08 1359Pharmacare Limited, Woodmead

09 77Strides Pharma SA (Pty) Ltd

10 1Strides S.A. Pharmaceuticals (Pty) Ltd

11 63M South Africa (Pty) Ltd

12 9A. Menarini

13 9AHN Pharma (Pty) Limited

14 8APOTHECON LABS cc

15 97Abbott Laboratories SA (Pty) Ltd

16 50Abex Pharmaceutica (Pty) Ltd

17 184Accord Healthcare (Pty) Ltd

18 146Acino Pharma (Pty) Ltd

19 10Actavis Pharma (Pty) Ltd

20 65Activo Health (Pty) Ltd

21 52Actor Pharma (Pty) Ltd

22 1Actor Pharma (Pty) Ltd.

23 1141Adcock Ingram Critical Care (Pty) Ltd

24 6Adcock Ingram Healthcare (Pty) Ltd

25 1424Adcock Ingram Limited

26 2Adven Pharma (Pty) Ltd

27 77Akacia Health Care (Pty) Ltd

28 22Alcon Laboratories (Sa) (Pty) Ltd

29 22Alliance Pharma (Pty) Ltd

30 93Alliance Pharmaceuticals

31 13Allied Drug Company

32 27Amgen South Africa (Pty) Ltd

33 3Ando Pharma (Pty) Ltd

34 1Applicant Name as Registered with MCCSAHPRA

35 51Arrow Pharma South Africa (Pty) Ltd

36 48Arya Pharma (Pty) Ltd

37 96Ascend Laboratories (Pty) Ltd

38 7Ascendis Pharma (Pty) Ltd

39 25Astellas Pharma (Pty) Ltd

40 6AstraZeneca Pharmaceuticals (Pty) Ltd

41 25Astral Pharma (Pty) Ltd

42 9Astrazeneca Pharmaceuticals (Pty) Ltd

43 3Astrazeneca Pharmaceuticals (Pty) Ltd - Bryanston

44 98Astrazeneca Pharmaceuticals (Pty) Ltd - Sunninghill

45 32Astrazeneca Pharmaceuticals (Pty) Ltd- Bryanston

46 2Astrazeneca Pharmaceuticals (Pty) Ltd- Sunninghill

47 47Aurobindo Pharma (Pty) Ltd

48 140Aurogen South Africa (Pty) Ltd

49 160Austell Laboratories (Pty) Ltd

50 5Austell Pharmaceuticals (Pty) Ltd

51 176Austell Pharmaceuticals (Pty) Ltd

52 55Axim Pharmaceuticals (Pty) Ltd

53 748B. Braun Medical (Pty) Ltd

54 1BEIGENE SOUTH AFRICA (PTY) LTD

55 91Baroque Pharmaceuticals (Pty) Ltd

56 4Barrs Pharmaceutical Industries (Pty) Ltd

57 10Baxter HealthCare South Africa (Pty) Ltd

58 74Baxter Healthcare South Africa (Pty) Ltd

59 192Bayer (Pty) Ltd

60 61Be Tabs Pharmaceuticals (Pty) Ltd

61 4Bennetts The Chemists (Pty) Ltd

62 3Biomab Innovation (Pty) Ltd

63 226Biotech Laboratories (Pty) Ltd

64 3Bliss Pharmaceuticals

65 53Bodene (Pty) Ltd

66 153Boston Scientific (Pty) Ltd

67 6Brimpharm SA (Pty) Ltd

68 5Brimpharm Sa (Pty) Ltd

69 73Bristol-Myers Squibb (Pty) Ltd

70 12Brunel Laboratoria (Pty) Ltd

71 11Camox Pharmaceuticals (Pty) Ltd

72 33Caps Pharmaceuticals

73 1Cipla Life Sciences (Pty) Ltd

74 666Cipla Medpro (Pty) Ltd

75 6Cipla Medpro Manufacturing (Pty) Ltd

76 1Clinigen Group

77 5Concord Food & Drug Distributors CC

78 1Cospharm

79 6Cospharm Investment (PTY) LTD

80 2Crux Pharmaceuticals (Pty) Ltd

81 3Curanto Pharma (Pty) Ltd

82 6Delfran (Pty) Ltd

83 51Dezzo Trading 392 (Pty) Limited T/A Indo Pharma

84 24Dezzo Trading 392 (Pty) Ltd

85 2Eco Pharmaceuticals (Pty) Ltd

86 11Eisai Pharmaceuticals Africa (Pty) Ltd

87 72Eli Lilly (SA) (Pty) Ltd

88 1Elttab Pharmaceuticals

89 40Emcure Pharmaceuticals South Africa (Pty) Ltd

90 10Encha Health (Pty) Ltd

91 113Equity Pharmaceuticals (Pty) Ltd

92 67Eurolab (Pty) Ltd

93 27F.D.C. SA (PTY) LTD

94 2F.D.C. SA (Pty) Ltd

95 41Ferring (Pty) Ltd

96 89Forrester Pharma (Pty) Ltd

97 135Fresenius Kabi Manufacturing SA (Pty) Ltd

98 1051Fresenius Kabi SA (Pty) Ltd

99 1338Fresenius Kabi South Africa (Pty) Ltd

100 37Fresenius Medical Care SA (Pty) Ltd

101 21GE Healthcare (Pty) Ltd

102 17Galderma Laboratories South Africa (Pty) Ltd

103 14Gen-Eye (Pty) Ltd

104 16Gen-Eye (pty) Ltd

105 7Genop Healthcare (Pty) Ltd

106 5Gilead Sciences South Africa (Pty) Ltd

107 2GlaxoSmithKline Consumer Healthcare (Pty) Ltd

108 36GlaxoSmithKline Consumer Healthcare South Africa (Pty) Ltd

109 226GlaxoSmithKline South Africa (Pty) Limited

110 2GlaxoSmithKline South Africa Pty Ltd

111 121Glaxosmithkline South Africa (Pty) Ltd - Cape Town

112 53Glenmark Pharmaceuticals South Africa (Pty) Ltd

113 2Goldex 775 (Pty) Ltd

114 63Guerbet South Africa (Pty) Ltd

115 126Gulf Drug Company (Pty) Ltd

116 30H. Lundbeck (Pty) Ltd

117 4Haleon

118 7Henry Schein Dental Warehouse (Pty) Ltd

119 172Hetero Drugs South Africa (Pty) Ltd

120 1IPM South Africa NPC

121 7Imperial Market Access Healthcare SA (Pty) Ltd

122 152Ingelheim Pharmaceuticals (Pty) Ltd

123 1Ingwe Lifescience (Pty) Ltd

124 119Innovata Pharmaceuticals (Pty) Ltd

125 193Janssen Pharmaceutica (Pty) Ltd

126 198Johnson & Johnson (Pty) Ltd

127 36Jubilant Pharma SA (Pty) Ltd

128 10Juno Pharma SA (Pty) Ltd

129 17Kahma Biotech (Pty) Ltd

130 42Key Oncologics (Pty) Ltd

131 52Kiara Health (PTY) LTD

132 27LHC Pharmaceuticals (Pty) Ltd

133 4Lamar International (Pty) Ltd

134 6LeBasi Pharmaceuticals (Pty) Ltd

135 47LeBasi Pharmaceuticals CC

136 14Lebasi Pharmaceuticals (Pty) Ltd

137 15Lebasi Pharmaceuticals CC

138 68Litha Pharma (Pty) Ltd

139 2Litha Vaccines

140 2Loock Pharmaceuticals (Pty) Ltd

141 19MC Pharma (Pty) Ltd

142 3MDI HEALTHCARE CC

143 146MSD (Pty) Ltd

144 291Macleods Pharmaceuticals SA (Pty) Ltd

145 28Mallinckrodt (Pty) Ltd

146 8Meda Pharma South Africa (Pty) Ltd

147 3Medchem Pharmaceuticals

148 7Medi Challenge

149 77Medicine Developers International CC

150 15Medicine Developers International Healthcare cc

151 17Medivision (Pty) Ltd

152 3Medpro Pharmaceutica (Pty) Ltd

153 1Medwich Pharma (Pty) Ltd

154 4Mentholatum South Africa (Pty) Ltd

155 123Merck (Pty) Ltd

156 1MeyerZall Laboratories (Pty) Ltd

157 18Micro Healthcare

158 2Mirren (Pty) Ltd

159 42Mundipharma (Pty) Ltd

160 128Mylan (Pty) Ltd

161 79NTP Radioisotopes (Pty) Ltd

162 21National Bioproducts Institute (NPC)

163 6Norgine (Pty) Ltd

164 65Novagen Pharma (Pty) Ltd

165 327Novartis South Africa (Pty) Ltd

166 64Novo Nordisk (Pty) Ltd

167 6ORTHOMEDICS PHARMACEUTICALS (PTY) LTD

168 24Octapharma SA (Pty) Ltd

169 105Oethmaan Biosims (Pty) Ltd

170 2Omnimed

171 17Opella Healthcare South Africa (Pty) Ltd

172 3Opus Pharmaceuticals (Pty) Limited

173 1Orchid Pharmaceuticals SA (Pty) Ltd

174 114Organon South Africa (Pty) Ltd

175 1PPS Pharmaceuticals (Pty) Ltd

176 273Pfizer Laboratories (Pty) Ltd

177 360Pharma Dynamics (Pty) Ltd

178 49Pharma Q (Pty) Ltd

179 48Pharma-Q Holdings (Pty) Ltd

180 1Pharmacentrix (Pty) Ltd

181 9Pharmaceutical Contractors (Pty) Ltd

182 44Pharmaceutical Enterprises (Pty) Ltd

183 27Pharmachemie (Pty) Ltd

184 2Pharmacia South Africa (Pty) Ltd

185 66Pharmaco Distribution (Pty) Ltd

186 44Pharmacorp (Pty) Ltd

187 7Pharmafrica (Pty) Ltd

188 15Pharmaplan (Pty) Ltd

189 12Pharmascript Pharmaceuticals Ltd

190 6Phyto OTC Health (Pty) Ltd

191 4Pierre Fabre South Africa (Pty) Ltd

192 7Piramal Critical Care South Africa (Pty) Ltd

193 2Portfolio Laboratories (Pty) Ltd

194 22Procter & Gamble SA (Pty) Ltd

195 4RX Medicals (Pty) Ltd

196 470Ranbaxy Pharmaceuticals (Pty) Ltd

197 89Ranbaxy S.A (Pty) Ltd

198 35Reckitt Benckiser Pharmaceuticals (Pty) Ltd

199 5Resmed Healthcare

200 1Roche Products (Pty) Ltd

201 144Roche Products (Pty) Ltd

202 15Ruby Pharmaceuticals (Pty) Ltd

203 2SCP Pharmaceuticals (Pty) Ltd

204 10SMART PHARMACEUTICALS (PTY) LTD

205 34Safeline Pharmaceuticals (Pty) Ltd

206 613Sandoz SA (Pty) Ltd

207 71Sandoz SA Pty Ltd

208 22Schering-Plough (Pty) Ltd - (Site1)

209 24Sekpharma (Pty) Ltd

210 162Servier Laboratories S.A. (Pty) Ltd

211 6Shanur Healthcare (Pty) Ltd

212 8Smith & Nephew Pharmaceuticals (Pty) Limited

213 30Soflens (Pty) Ltd

214 8Sonke Pharmaceuticals (Pty) Ltd

215 6South African Vaccine producers (PTY) LTD

216 3Spear Pharmaceuticals

217 75Specpharm (Pty) Ltd

218 2Specpharm Holdings (Pty) Ltd

219 2Sun Pharmaceuticals SA (Pty) Ltd

220 45Takeda (Pty) Ltd

221 5Technikon Laboratories (Pty) Ltd

222 6Tema Medical (Pty) Ltd

223 220Teva Pharmaceuticals (Pty) Ltd

224 5The Biovac Institute

225 57Thebe Medicare

226 16Thebe Medicare (Pty) Ltd

227 207Trinity Pharma (Pty) Ltd

228 12Umsebe Healthcare

229 57Unichem SA (Pty) Ltd

230 146Unicorn Pharmaceuticals (Pty) Ltd

231 90Unimed Healthcare (Pty) Ltd

232 1Viatris

233 199Viatris Healthcare (Pty) Ltd

234 115Viatris South Africa (Pty) Ltd

235 14Watson Pharma No. 1 (Pty) Ltd

236 22Western Province Blood Transfusion Service

237 5Wyeth Consumer Healthcare

238 94Xixia Pharmaceuticals (Pty) Ltd

239 29Zentiva South Africa (Pty) Ltd-Midrand

240 4Zimbili Pharma CC

241 2Zydus Healthcare

242 231Zydus Healthcare SA (Pty) Ltd

243 103iNova Pharmaceuticals (Pty) Ltd

244 15iPharma (Pty) Ltd

245 18iThemba LABS

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PharmaCompass

01

Village de la Chimie
Not Confirmed
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Village de la Chimie
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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02

Village de la Chimie
Not Confirmed
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Village de la Chimie
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

Village de la Chimie
Not Confirmed
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Village de la Chimie
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

Village de la Chimie
Not Confirmed
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Village de la Chimie
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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05

Village de la Chimie
Not Confirmed
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Village de la Chimie
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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06

Village de la Chimie
Not Confirmed
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Village de la Chimie
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

Village de la Chimie
Not Confirmed
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Village de la Chimie
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

Village de la Chimie
Not Confirmed
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Village de la Chimie
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

Village de la Chimie
Not Confirmed
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Village de la Chimie
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

Applicant Name as Registered with MCCSAH...

Country
Village de la Chimie
Not Confirmed
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Applicant Name as Registered with MCCSAH...

Country
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Village de la Chimie
Not Confirmed

Active Ingredients

Brand Name : Medicine Proprietary Name

Dosage Form : Dosage Form

Dosage Strength : StrengthUnit

Packaging : Pack SizeXQuantityUnit

Approval Date :

Application Number :

Regulatory Info : Originator or Generic

Registration Country : South Africa

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