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Drug Approvals in South Africa

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01 4Genzyme Biopharmaceuticals SA (Pty) Ltd

02 370Sanofi Aventis South Africa (Pty) Ltd

03 33Winthrop Pharmaceuticals (Pty) Ltd

04 63AbbVie (Pty) Ltd

05 1Abbvie (Pty) Ltd

06 4Allergan Pharmaceuticals (Pty) Ltd

07 1359Pharmacare Limited, Woodmead

08 152Dr Reddy's Laboratories (Pty) Ltd

09 77Strides Pharma SA (Pty) Ltd

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

11 63M South Africa (Pty) Ltd

12 9AHN Pharma (Pty) Limited

13 8APOTHECON LABS cc

14 97Abbott Laboratories SA (Pty) Ltd

15 47Abex Pharmaceutica (Pty) Ltd

16 184Accord Healthcare (Pty) Ltd

17 145Acino Pharma (Pty) Ltd

18 10Actavis Pharma (Pty) Ltd

19 65Activo Health (Pty) Ltd

20 52Actor Pharma (Pty) Ltd

21 1Actor Pharma (Pty) Ltd.

22 1141Adcock Ingram Critical Care (Pty) Ltd

23 6Adcock Ingram Healthcare (Pty) Ltd

24 1416Adcock 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 27Amgen South Africa (Pty) Ltd

32 3Ando Pharma (Pty) Ltd

33 1Applicant Name as Registered with MCCSAHPRA

34 53Arrow Pharma South Africa (Pty) Ltd

35 45Arya Pharma (Pty) Ltd

36 89Ascend Laboratories (Pty) Ltd

37 7Ascendis Pharma (Pty) Ltd

38 25Astellas Pharma (Pty) Ltd

39 6AstraZeneca Pharmaceuticals (Pty) Ltd

40 25Astral Pharma (Pty) Ltd

41 9Astrazeneca Pharmaceuticals (Pty) Ltd

42 3Astrazeneca Pharmaceuticals (Pty) Ltd - Bryanston

43 98Astrazeneca Pharmaceuticals (Pty) Ltd - Sunninghill

44 32Astrazeneca Pharmaceuticals (Pty) Ltd- Bryanston

45 2Astrazeneca Pharmaceuticals (Pty) Ltd- Sunninghill

46 47Aurobindo Pharma (Pty) Ltd

47 140Aurogen South Africa (Pty) Ltd

48 156Austell Laboratories (Pty) Ltd

49 5Austell Pharmaceuticals (Pty) Ltd

50 161Austell Pharmaceuticals (Pty) Ltd

51 55Axim Pharmaceuticals (Pty) Ltd

52 747B. Braun Medical (Pty) Ltd

53 1BEIGENE SOUTH AFRICA (PTY) LTD

54 91Baroque Pharmaceuticals (Pty) Ltd

55 4Barrs Pharmaceutical Industries (Pty) Ltd

56 10Baxter HealthCare South Africa (Pty) Ltd

57 74Baxter Healthcare South Africa (Pty) Ltd

58 191Bayer (Pty) Ltd

59 61Be Tabs Pharmaceuticals (Pty) Ltd

60 4Bennetts The Chemists (Pty) Ltd

61 225Biotech Laboratories (Pty) Ltd

62 3Bliss Pharmaceuticals

63 55Bodene (Pty) Ltd

64 153Boston Scientific (Pty) Ltd

65 6Brimpharm SA (Pty) Ltd

66 5Brimpharm Sa (Pty) Ltd

67 73Bristol-Myers Squibb (Pty) Ltd

68 12Brunel Laboratoria (Pty) Ltd

69 27Camox Pharmaceuticals (Pty) Ltd

70 33Caps Pharmaceuticals

71 1Cipla Life Sciences (Pty) Ltd

72 653Cipla Medpro (Pty) Ltd

73 6Cipla Medpro Manufacturing (Pty) Ltd

74 5Concord Food & Drug Distributors CC

75 6Cospharm Investment (PTY) LTD

76 1Cospharm Investments (Pty) Ltd

77 2Crux Pharmaceuticals (Pty) Ltd

78 3Curanto Pharma (Pty) Ltd

79 6Delfran (Pty) Ltd

80 51Dezzo Trading 392 (Pty) Limited T/A Indo Pharma

81 23Dezzo Trading 392 (Pty) Ltd

82 2Eco Pharmaceuticals (Pty) Ltd

83 11Eisai Pharmaceuticals Africa (Pty) Ltd

84 72Eli Lilly (SA) (Pty) Ltd

85 1Elttab Pharmaceuticals

86 37Emcure Pharmaceuticals South Africa (Pty) Ltd

87 10Encha Health (Pty) Ltd

88 108Equity Pharmaceuticals (Pty) Ltd

89 68Eurolab (Pty) Ltd

90 27F.D.C. SA (PTY) LTD

91 2F.D.C. SA (Pty) Ltd

92 41Ferring (Pty) Ltd

93 89Forrester Pharma (Pty) Ltd

94 133Fresenius Kabi Manufacturing SA (Pty) Ltd

95 1051Fresenius Kabi SA (Pty) Ltd

96 1336Fresenius Kabi South Africa (Pty) Ltd

97 37Fresenius Medical Care SA (Pty) Ltd

98 21GE Healthcare (Pty) Ltd

99 17Galderma Laboratories South Africa (Pty) Ltd

100 14Gen-Eye (Pty) Ltd

101 16Gen-Eye (pty) Ltd

102 7Genop Healthcare (Pty) Ltd

103 5Gilead Sciences South Africa (Pty) Ltd

104 2GlaxoSmithKline Consumer Healthcare (Pty) Ltd

105 40GlaxoSmithKline Consumer Healthcare South Africa (Pty) Ltd

106 226GlaxoSmithKline South Africa (Pty) Limited

107 2GlaxoSmithKline South Africa Pty Ltd

108 121Glaxosmithkline South Africa (Pty) Ltd - Cape Town

109 53Glenmark Pharmaceuticals South Africa (Pty) Ltd

110 2Goldex 775 (Pty) Ltd

111 63Guerbet South Africa (Pty) Ltd

112 126Gulf Drug Company (Pty) Ltd

113 30H. Lundbeck (Pty) Ltd

114 1Haleon S. A. (Pty) Ltd 

115 7Henry Schein Dental Warehouse (Pty) Ltd

116 169Hetero Drugs South Africa (Pty) Ltd

117 1IPM South Africa NPC

118 7Imperial Market Access Healthcare SA (Pty) Ltd

119 152Ingelheim Pharmaceuticals (Pty) Ltd

120 1Ingwe Lifescience (Pty) Ltd

121 118Innovata Pharmaceuticals (Pty) Ltd

122 193Janssen Pharmaceutica (Pty) Ltd

123 198Johnson & Johnson (Pty) Ltd

124 36Jubilant Pharma SA (Pty) Ltd

125 6Juno Pharma SA (Pty) Ltd

126 20Kahma Biotech (Pty) Ltd

127 42Key Oncologics (Pty) Ltd

128 52Kiara Health (PTY) LTD

129 27LHC Pharmaceuticals (Pty) Ltd

130 4Lamar International (Pty) Ltd

131 6LeBasi Pharmaceuticals (Pty) Ltd

132 47LeBasi Pharmaceuticals CC

133 12Lebasi Pharmaceuticals (Pty) Ltd

134 15Lebasi Pharmaceuticals CC

135 68Litha Pharma (Pty) Ltd

136 2Litha Vaccines

137 2Loock Pharmaceuticals (Pty) Ltd

138 19MC Pharma (Pty) Ltd

139 3MDI HEALTHCARE CC

140 146MSD (Pty) Ltd

141 287Macleods Pharmaceuticals SA (Pty) Ltd

142 28Mallinckrodt (Pty) Ltd

143 8Meda Pharma South Africa (Pty) Ltd

144 3Medchem Pharmaceuticals

145 7Medi Challenge

146 77Medicine Developers International CC

147 15Medicine Developers International Healthcare cc

148 17Medivision (Pty) Ltd

149 3Medpro Pharmaceutica (Pty) Ltd

150 1Medwich Pharma (Pty) Ltd

151 9Menarini South Africa (Pty) Ltd

152 4Mentholatum South Africa (Pty) Ltd

153 123Merck (Pty) Ltd

154 1MeyerZall Laboratories (Pty) Ltd

155 18Micro Healthcare

156 2Mirren (Pty) Ltd

157 42Mundipharma (Pty) Ltd

158 181Mylan (Pty) Ltd

159 79NTP Radioisotopes (Pty) Ltd

160 21National Bioproducts Institute (NPC)

161 6Norgine (Pty) Ltd

162 65Novagen Pharma (Pty) Ltd

163 327Novartis South Africa (Pty) Ltd

164 64Novo Nordisk (Pty) Ltd

165 6ORTHOMEDICS PHARMACEUTICALS (PTY) LTD

166 24Octapharma SA (Pty) Ltd

167 102Oethmaan Biosims (Pty) Ltd

168 2Omnimed

169 17Opella Healthcare South Africa (Pty) Ltd

170 3Opus Pharmaceuticals (Pty) Limited

171 1Orchid Pharmaceuticals SA (Pty) Ltd

172 114Organon South Africa (Pty) Ltd

173 1PPS Pharmaceuticals (Pty) Ltd

174 273Pfizer Laboratories (Pty) Ltd

175 357Pharma Dynamics (Pty) Ltd

176 49Pharma Q (Pty) Ltd

177 48Pharma-Q Holdings (Pty) Ltd

178 1Pharmacentrix (Pty) Ltd

179 9Pharmaceutical Contractors (Pty) Ltd

180 44Pharmaceutical Enterprises (Pty) Ltd

181 27Pharmachemie (Pty) Ltd

182 2Pharmacia South Africa (Pty) Ltd

183 66Pharmaco Distribution (Pty) Ltd

184 44Pharmacorp (Pty) Ltd

185 7Pharmafrica (Pty) Ltd

186 15Pharmaplan (Pty) Ltd

187 12Pharmascript Pharmaceuticals Ltd

188 6Phyto OTC Health (Pty) Ltd

189 4Pierre Fabre South Africa (Pty) Ltd

190 7Piramal Critical Care South Africa (Pty) Ltd

191 2Portfolio Laboratories (Pty) Ltd

192 22Procter & Gamble SA (Pty) Ltd

193 4RX Medicals (Pty) Ltd

194 469Ranbaxy Pharmaceuticals (Pty) Ltd

195 89Ranbaxy S.A (Pty) Ltd

196 35Reckitt Benckiser Pharmaceuticals (Pty) Ltd

197 5Resmed Healthcare

198 1Roche Products (Pty) Ltd

199 144Roche Products (Pty) Ltd

200 15Ruby Pharmaceuticals (Pty) Ltd

201 2SCP Pharmaceuticals (Pty) Ltd

202 10SMART PHARMACEUTICALS (PTY) LTD

203 34Safeline Pharmaceuticals (Pty) Ltd

204 610Sandoz SA (Pty) Ltd

205 71Sandoz SA Pty Ltd

206 22Schering-Plough (Pty) Ltd - (Site1)

207 24Sekpharma (Pty) Ltd

208 138Servier Laboratories S.A. (Pty) Ltd

209 6Shanur Healthcare (Pty) Ltd

210 8Smith & Nephew Pharmaceuticals (Pty) Limited

211 30Soflens (Pty) Ltd

212 8Sonke Pharmaceuticals (Pty) Ltd

213 6South African Vaccine producers (PTY) LTD

214 3Spear Pharmaceuticals

215 75Specpharm (Pty) Ltd

216 2Specpharm Holdings (Pty) Ltd

217 2Sun Pharmaceuticals SA (Pty) Ltd

218 45Takeda (Pty) Ltd

219 5Technikon Laboratories (Pty) Ltd

220 6Tema Medical (Pty) Ltd

221 217Teva Pharmaceuticals (Pty) Ltd

222 5The Biovac Institute

223 57Thebe Medicare

224 16Thebe Medicare (Pty) Ltd

225 203Trinity Pharma (Pty) Ltd

226 12Umsebe Healthcare

227 57Unichem SA (Pty) Ltd

228 144Unicorn Pharmaceuticals (Pty) Ltd

229 86Unimed Healthcare (Pty) Ltd

230 156Viatris Healthcare (Pty) Ltd

231 94Viatris South Africa (Pty) Ltd

232 14Watson Pharma No. 1 (Pty) Ltd

233 22Western Province Blood Transfusion Service

234 5Wyeth Consumer Healthcare

235 103Xixia Pharmaceuticals (Pty) Ltd

236 29Zentiva South Africa (Pty) Ltd-Midrand

237 4Zimbili Pharma CC

238 220Zydus Healthcare SA (Pty) Ltd

239 103iNova Pharmaceuticals (Pty) Ltd

240 15iPharma (Pty) Ltd

241 18iThemba LABS

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PharmaCompass

01

CTAD25
Not Confirmed
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CTAD25
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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

CTAD25
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CTAD25
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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

CTAD25
Not Confirmed
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CTAD25
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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04

CTAD25
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CTAD25
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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

CTAD25
Not Confirmed
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CTAD25
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

CTAD25
Not Confirmed
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CTAD25
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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07

CTAD25
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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

CTAD25
Not Confirmed
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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

CTAD25
Not Confirmed
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CTAD25
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
CTAD25
Not Confirmed
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Applicant Name as Registered with MCCSAH...

Country
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CTAD25
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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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