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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 1360Pharmacare Limited, Woodmead

08 77Strides 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 50Abex Pharmaceutica (Pty) Ltd

15 184Accord Healthcare (Pty) Ltd

16 146Acino Pharma (Pty) Ltd

17 10Actavis Pharma (Pty) Ltd

18 65Activo Health (Pty) Ltd

19 52Actor Pharma (Pty) Ltd

20 1Actor Pharma (Pty) Ltd.

21 1141Adcock Ingram Critical Care (Pty) Ltd

22 6Adcock Ingram Healthcare (Pty) Ltd

23 1424Adcock 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 1Applicant Name as Registered with MCCSAHPRA

33 51Arrow Pharma South Africa (Pty) Ltd

34 48Arya Pharma (Pty) Ltd

35 96Ascend Laboratories (Pty) Ltd

36 7Ascendis Pharma (Pty) Ltd

37 25Astellas Pharma (Pty) Ltd

38 6AstraZeneca Pharmaceuticals (Pty) Ltd

39 25Astral Pharma (Pty) Ltd

40 9Astrazeneca Pharmaceuticals (Pty) Ltd

41 3Astrazeneca Pharmaceuticals (Pty) Ltd - Bryanston

42 98Astrazeneca Pharmaceuticals (Pty) Ltd - Sunninghill

43 32Astrazeneca Pharmaceuticals (Pty) Ltd- Bryanston

44 2Astrazeneca Pharmaceuticals (Pty) Ltd- Sunninghill

45 47Aurobindo Pharma (Pty) Ltd

46 140Aurogen South Africa (Pty) Ltd

47 160Austell Laboratories (Pty) Ltd

48 5Austell Pharmaceuticals (Pty) Ltd

49 176Austell Pharmaceuticals (Pty) Ltd

50 55Axim Pharmaceuticals (Pty) Ltd

51 748B. Braun Medical (Pty) Ltd

52 1BEIGENE SOUTH AFRICA (PTY) LTD

53 91Baroque Pharmaceuticals (Pty) Ltd

54 4Barrs Pharmaceutical Industries (Pty) Ltd

55 10Baxter HealthCare South Africa (Pty) Ltd

56 74Baxter Healthcare South Africa (Pty) Ltd

57 192Bayer (Pty) Ltd

58 61Be Tabs Pharmaceuticals (Pty) Ltd

59 4Bennetts The Chemists (Pty) Ltd

60 3Biomab Innovation (Pty) Ltd

61 226Biotech Laboratories (Pty) Ltd

62 3Bliss Pharmaceuticals

63 53Bodene (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 11Camox Pharmaceuticals (Pty) Ltd

70 33Caps Pharmaceuticals

71 1Cipla Life Sciences (Pty) Ltd

72 666Cipla 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 24Dezzo Trading 392 (Pty) Ltd

82 155Dr Reddy's Laboratories (Pty) Ltd

83 2Eco Pharmaceuticals (Pty) Ltd

84 11Eisai Pharmaceuticals Africa (Pty) Ltd

85 72Eli Lilly (SA) (Pty) Ltd

86 1Elttab Pharmaceuticals

87 40Emcure Pharmaceuticals South Africa (Pty) Ltd

88 10Encha Health (Pty) Ltd

89 114Equity Pharmaceuticals (Pty) Ltd

90 67Eurolab (Pty) Ltd

91 27F.D.C. SA (PTY) LTD

92 2F.D.C. SA (Pty) Ltd

93 41Ferring (Pty) Ltd

94 89Forrester Pharma (Pty) Ltd

95 135Fresenius Kabi Manufacturing SA (Pty) Ltd

96 1051Fresenius Kabi SA (Pty) Ltd

97 1338Fresenius Kabi South Africa (Pty) Ltd

98 37Fresenius Medical Care SA (Pty) Ltd

99 21GE Healthcare (Pty) Ltd

100 17Galderma Laboratories South Africa (Pty) Ltd

101 14Gen-Eye (Pty) Ltd

102 16Gen-Eye (pty) Ltd

103 7Genop Healthcare (Pty) Ltd

104 5Gilead Sciences South Africa (Pty) Ltd

105 2GlaxoSmithKline Consumer Healthcare (Pty) Ltd

106 36GlaxoSmithKline Consumer Healthcare South Africa (Pty) Ltd

107 226GlaxoSmithKline South Africa (Pty) Limited

108 2GlaxoSmithKline South Africa Pty Ltd

109 121Glaxosmithkline South Africa (Pty) Ltd - Cape Town

110 53Glenmark Pharmaceuticals South Africa (Pty) Ltd

111 2Goldex 775 (Pty) Ltd

112 63Guerbet South Africa (Pty) Ltd

113 126Gulf Drug Company (Pty) Ltd

114 30H. Lundbeck (Pty) Ltd

115 4Haleon S. A. (Pty) Ltd 

116 7Henry Schein Dental Warehouse (Pty) Ltd

117 172Hetero Drugs South Africa (Pty) Ltd

118 1IPM South Africa NPC

119 7Imperial Market Access Healthcare SA (Pty) Ltd

120 152Ingelheim Pharmaceuticals (Pty) Ltd

121 1Ingwe Lifescience (Pty) Ltd

122 119Innovata Pharmaceuticals (Pty) Ltd

123 193Janssen Pharmaceutica (Pty) Ltd

124 198Johnson & Johnson (Pty) Ltd

125 36Jubilant Pharma SA (Pty) Ltd

126 10Juno Pharma SA (Pty) Ltd

127 17Kahma Biotech (Pty) Ltd

128 42Key Oncologics (Pty) Ltd

129 52Kiara Health (PTY) LTD

130 27LHC Pharmaceuticals (Pty) Ltd

131 4Lamar International (Pty) Ltd

132 6LeBasi Pharmaceuticals (Pty) Ltd

133 47LeBasi Pharmaceuticals CC

134 14Lebasi Pharmaceuticals (Pty) Ltd

135 15Lebasi Pharmaceuticals CC

136 68Litha Pharma (Pty) Ltd

137 2Litha Vaccines

138 2Loock Pharmaceuticals (Pty) Ltd

139 19MC Pharma (Pty) Ltd

140 3MDI HEALTHCARE CC

141 146MSD (Pty) Ltd

142 291Macleods Pharmaceuticals SA (Pty) Ltd

143 28Mallinckrodt (Pty) Ltd

144 8Meda Pharma South Africa (Pty) Ltd

145 3Medchem Pharmaceuticals

146 7Medi Challenge

147 77Medicine Developers International CC

148 15Medicine Developers International Healthcare cc

149 17Medivision (Pty) Ltd

150 3Medpro Pharmaceutica (Pty) Ltd

151 1Medwich Pharma (Pty) Ltd

152 9Menarini South Africa (Pty) Ltd

153 4Mentholatum South Africa (Pty) Ltd

154 123Merck (Pty) Ltd

155 1MeyerZall Laboratories (Pty) Ltd

156 18Micro Healthcare

157 2Mirren (Pty) Ltd

158 42Mundipharma (Pty) Ltd

159 128Mylan (Pty) Ltd

160 79NTP Radioisotopes (Pty) Ltd

161 21National Bioproducts Institute (NPC)

162 6Norgine (Pty) Ltd

163 65Novagen Pharma (Pty) Ltd

164 327Novartis South Africa (Pty) Ltd

165 64Novo Nordisk (Pty) Ltd

166 6ORTHOMEDICS PHARMACEUTICALS (PTY) LTD

167 24Octapharma SA (Pty) Ltd

168 105Oethmaan Biosims (Pty) Ltd

169 2Omnimed

170 17Opella Healthcare South Africa (Pty) Ltd

171 3Opus Pharmaceuticals (Pty) Limited

172 1Orchid Pharmaceuticals SA (Pty) Ltd

173 114Organon South Africa (Pty) Ltd

174 1PPS Pharmaceuticals (Pty) Ltd

175 273Pfizer Laboratories (Pty) Ltd

176 360Pharma Dynamics (Pty) Ltd

177 49Pharma Q (Pty) Ltd

178 48Pharma-Q Holdings (Pty) Ltd

179 1Pharmacentrix (Pty) Ltd

180 9Pharmaceutical Contractors (Pty) Ltd

181 44Pharmaceutical Enterprises (Pty) Ltd

182 27Pharmachemie (Pty) Ltd

183 2Pharmacia South Africa (Pty) Ltd

184 66Pharmaco Distribution (Pty) Ltd

185 44Pharmacorp (Pty) Ltd

186 7Pharmafrica (Pty) Ltd

187 15Pharmaplan (Pty) Ltd

188 12Pharmascript Pharmaceuticals Ltd

189 6Phyto OTC Health (Pty) Ltd

190 4Pierre Fabre South Africa (Pty) Ltd

191 7Piramal Critical Care South Africa (Pty) Ltd

192 2Portfolio Laboratories (Pty) Ltd

193 22Procter & Gamble SA (Pty) Ltd

194 4RX Medicals (Pty) Ltd

195 470Ranbaxy Pharmaceuticals (Pty) Ltd

196 89Ranbaxy S.A (Pty) Ltd

197 35Reckitt Benckiser Pharmaceuticals (Pty) Ltd

198 5Resmed Healthcare

199 1Roche Products (Pty) Ltd

200 144Roche Products (Pty) Ltd

201 15Ruby Pharmaceuticals (Pty) Ltd

202 2SCP Pharmaceuticals (Pty) Ltd

203 10SMART PHARMACEUTICALS (PTY) LTD

204 34Safeline Pharmaceuticals (Pty) Ltd

205 613Sandoz SA (Pty) Ltd

206 71Sandoz SA Pty Ltd

207 22Schering-Plough (Pty) Ltd - (Site1)

208 24Sekpharma (Pty) Ltd

209 162Servier Laboratories S.A. (Pty) Ltd

210 6Shanur Healthcare (Pty) Ltd

211 8Smith & Nephew Pharmaceuticals (Pty) Limited

212 30Soflens (Pty) Ltd

213 8Sonke Pharmaceuticals (Pty) Ltd

214 6South African Vaccine producers (PTY) LTD

215 3Spear Pharmaceuticals

216 75Specpharm (Pty) Ltd

217 2Specpharm Holdings (Pty) Ltd

218 2Sun Pharmaceuticals SA (Pty) Ltd

219 45Takeda (Pty) Ltd

220 5Technikon Laboratories (Pty) Ltd

221 6Tema Medical (Pty) Ltd

222 220Teva Pharmaceuticals (Pty) Ltd

223 5The Biovac Institute

224 57Thebe Medicare

225 16Thebe Medicare (Pty) Ltd

226 207Trinity Pharma (Pty) Ltd

227 12Umsebe Healthcare

228 57Unichem SA (Pty) Ltd

229 146Unicorn Pharmaceuticals (Pty) Ltd

230 90Unimed Healthcare (Pty) Ltd

231 200Viatris Healthcare (Pty) Ltd

232 115Viatris South Africa (Pty) Ltd

233 14Watson Pharma No. 1 (Pty) Ltd

234 22Western Province Blood Transfusion Service

235 5Wyeth Consumer Healthcare

236 94Xixia Pharmaceuticals (Pty) Ltd

237 29Zentiva South Africa (Pty) Ltd-Midrand

238 4Zimbili Pharma CC

239 233Zydus Healthcare SA (Pty) Ltd

240 103iNova Pharmaceuticals (Pty) Ltd

241 15iPharma (Pty) Ltd

242 18iThemba LABS

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PharmaCompass

01

BePharma
Not Confirmed
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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

BePharma
Not Confirmed
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BePharma
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

BePharma
Not Confirmed
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BePharma
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

BePharma
Not Confirmed
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BePharma
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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05

BePharma
Not Confirmed
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BePharma
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

BePharma
Not Confirmed
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BePharma
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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07

BePharma
Not Confirmed
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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

BePharma
Not Confirmed
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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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09

BePharma
Not Confirmed
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BePharma
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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10

Applicant Name as Registered with MCCSAH...

Country
BePharma
Not Confirmed
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Applicant Name as Registered with MCCSAH...

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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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