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01 37Adcock Ingram

02 16B. Braun Medical

03 2Baxter Healthcare South Africa (Pty) Ltd

04 2Darnytsia

05 2LeBasi Pharmaceuticals CC

06 2MONICO SpA

07 2SALF SpA

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PharmaCompass

01

Process Development
Not Confirmed
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Process Development
Not Confirmed

Calcium chloride dihydrate

Brand Name : Accusol 35 K0

Dosage Form : SOL

Dosage Strength : 0,3 g/1000ml

Packaging : 5000X1g/1000ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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02

Process Development
Not Confirmed
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Process Development
Not Confirmed

Calcium chloride dihydrate

Brand Name : Accusol 35 K2

Dosage Form : SOL

Dosage Strength : 0,3 g/1000ml

Packaging : 5000X1g/1000ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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03

Process Development
Not Confirmed
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Process Development
Not Confirmed

Calcium chloride dihydrate

Brand Name : Accusol 35 K4

Dosage Form : SOL

Dosage Strength : 0,3 g/1000ml

Packaging : 5000X1g/1000ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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04

Process Development
Not Confirmed
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Process Development
Not Confirmed

Calcium chloride dihydrate

Brand Name : Sabax Dianeal 2.5

Dosage Form : SOL

Dosage Strength : 257mg/1000ml

Packaging : 2500X1mg/1000ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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05

Process Development
Not Confirmed
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Process Development
Not Confirmed

Calcium chloride dihydrate

Brand Name : Sabax Dianeal 2.5

Dosage Form : SOL

Dosage Strength : 257mg/1000ml

Packaging : 2500X4mg/1000ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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06

Process Development
Not Confirmed
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Process Development
Not Confirmed

Calcium chloride dihydrate

Brand Name : Sabax Dianeal 2.5

Dosage Form : SOL

Dosage Strength : 257mg/1000ml

Packaging : 5000X4mg/1000ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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07

Process Development
Not Confirmed
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Process Development
Not Confirmed

Calcium chloride dihydrate

Brand Name : Sabax Dianeal 2.5

Dosage Form : SOL

Dosage Strength : 257mg/1000ml

Packaging : 5000X4mg/1000ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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08

Process Development
Not Confirmed
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Process Development
Not Confirmed

Calcium Chloride Dihydrate

Brand Name : Physioneal 40 Glucose 2.27% w/v/22.7 MG?ML

Dosage Form : SOL

Dosage Strength : 154g

Packaging : 2000X4g/1000ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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09

Process Development
Not Confirmed
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Process Development
Not Confirmed

Calcium Chloride dihydrate

Brand Name : Sabax Dianeal LS 4.25

Dosage Form : DIA

Dosage Strength : 154g

Packaging : 2500X1g/1l

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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10

Process Development
Not Confirmed
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Process Development
Not Confirmed

Calcium Chloride dihydrate

Brand Name : Sabax Dianeal LS 4.25

Dosage Form : DIA

Dosage Strength : 150g/1000ml

Packaging : 2500X4g/1l

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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11

Process Development
Not Confirmed
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Process Development
Not Confirmed

Calcium Chloride dihydrate

Brand Name : Sabax Dianeal LS 4.25

Dosage Form : DIA

Dosage Strength : 257mg

Packaging : 2500X4g/1l

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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12

Process Development
Not Confirmed
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Process Development
Not Confirmed

Calcium chloride dihydrate

Brand Name : Nutrineal PD4 with 1.1% amino acids

Dosage Form : SOL

Dosage Strength : 152mg/1000ml

Packaging : 2500X1g/1000ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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13

Process Development
Not Confirmed
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Process Development
Not Confirmed

Calcium chloride dihydrate

Brand Name : Nutrineal Pd4 W/1.1% Amin Acid (2.5L)

Dosage Form : SOL

Dosage Strength : 152mg/1000ml

Packaging : 2500X5g/1000ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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14

Process Development
Not Confirmed
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Process Development
Not Confirmed

Calcium Chloride dihydrate

Brand Name : Sabax Dianeal LS 4.25

Dosage Form : DIA

Dosage Strength : 3g/1000ml

Packaging : 1000X1g/1l

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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15

Process Development
Not Confirmed
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Process Development
Not Confirmed

Calcium Chloride dihydrate

Brand Name : Sabax Dianeal LS 4.25

Dosage Form : DIA

Dosage Strength : 257mg

Packaging : 1000X1g/1l

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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16

Process Development
Not Confirmed
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Process Development
Not Confirmed

Calcium Chloride dihydrate

Brand Name : Sabax Dianeal LS 4.25

Dosage Form : DIA

Dosage Strength : 152mg/1000ml

Packaging : 1000X6g/1l

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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17

SALF SpA

Country
Process Development
Not Confirmed
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SALF SpA

Country
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Process Development
Not Confirmed

Sodium Chloride; Potassium Chloride; Magnesium Chloride; Sinjarite; Sodium Bicarbonate

Brand Name : Cardioplegica Solution

Dosage Form :

Dosage Strength : 1 Bag 1,000 Ml  

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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18

MONICO SpA

Country
Process Development
Not Confirmed
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MONICO SpA

Country
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Process Development
Not Confirmed

Sodium Chloride; Potassium Chloride; Magnesium Chloride; Sinjarite; Sodium Bicarbonate

Brand Name : Cardioplegica Solution

Dosage Form :

Dosage Strength : To Soluz 480 Ml/500 Ml  

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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19

SALF SpA

Country
Process Development
Not Confirmed
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SALF SpA

Country
arrow
Process Development
Not Confirmed

Sodium Chloride; Potassium Chloride; Magnesium Chloride; Sinjarite; Sodium Bicarbonate

Brand Name : Cardioplegica Solution

Dosage Form :

Dosage Strength : 1 500 Ml Bottle  

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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20

MONICO SpA

Country
Process Development
Not Confirmed
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MONICO SpA

Country
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Process Development
Not Confirmed

Sodium Chloride; Potassium Chloride; Magnesium Chloride; Sinjarite; Sodium Bicarbonate

Brand Name : Cardioplegica Solution

Dosage Form :

Dosage Strength : B 1 Vial 20 Ml  

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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