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Ureadin® Ultra

Repairs and normalises dry skin

Ureadin Isdin® Actively penetrates skin layers “Urea Isdin® is not an inert ingredient that only influences the physical properties of the stratum corneum. It is an active molecule that stimulates the metabolic processes of the deepest layers of the skin”. Prof. Jean Krutmann

Ureadin Isdin® Stimulates physiological regenration mechanisms

Improves barrier function

Improves mechanical protection function, consistency and elasticity2 ® ®

Improves the immune system1 ®

Ureadin® Ultra Urea Isdin® has multiple actions based on the concentration used. It is fundamental to choose the most adequate concentration of Urea Isdin® for effectively managing the symptoms associated with each pathology. Moisturiser

Extensive calluses

Localised calluses

Ureadin® Ultra The Isdin keratoregulator care proposal. Specially made for the specialist

Ureadin® Ultra20 Anti-roughness Cream Hydrates and reduces roughness Restores smoothness to the skin

Ureadin® Ultra10 Reparative Lotion Plus Intense hydration of very dry and scaly skin Restores the barrier function

Ureadin® Ultra30 Exfoliating Cream Hyperkeratotic and callused skin

Ureadin® Ultra40 Intense Gel Oil Exfoliation Severe hyperkeratotic states of skin and nails

Ureadin® Ultra40

Main indications Onychogryphosis, nail thickening and sporiasis3,4,9 Severe hyperkeratosis and localised callus growths

Intense Gel Oil Exfoliation With 40% Urea Isdin® Thickened skin and nails Reduces severe hyperkeratotic states of skin and nails3,4 Adjuvant in antimycotic treatment5,6,7 Adjuvant in the treatment of psoriasis8 Gel oil with an exfoliant action3 Isdin’s innovative technology exceeds the formulative complexity of Urea thanks to the texture of Gel Oil, allowing it to provice: • • • •

Optimal texture Effective penetration Increased dermatological affinity Improved stability of the active ingredient

Method for use: 1 or 2 times daily.

Microscopic view of the gellified aqueous molecules which are each surrounded by a lipid layer.

For local application

Ureadin Ultra40

Onychogryphosis

Intense Gel Oil Exfoliation With 40% Urea Isdin® Thickened skin and nails Adjuvant to treatment of hyperkeratosis and mycotic infections Clinical Evidence

T15

Dosage 1 daily application for 15 days (occlusive).

Tinea Pedis. Negative mycology

Ureadin Ultra40 is effective as an adjuvant for penetrating the corneum stratum and place softening in patients who suffer from onychogryphosis and tinea pedis.4 ®

Gel Oil 30ml CN 153241.1

Dosage 1 daily application for 30 days.

T30

Ureadin® Ultra30

Exfoliation Cream With 30% Urea Isdin® Thickened skin and hardness Reduces hyperkeratotic areas10 Restores the skin’s barrier function and moisture level Especially indicated for feet, hands, knees and elbows Palmoplantar keratoderma10

Before Method for use: 1 or 2 times daily.

After

Main indications10 Extensive calluses Plantar keratoderma Adjuvant treatment of psoriatic skin conditions

Ureadin® Ultra30

Exfoliation Cream With 30% Urea Isdin® Thickened skin and hardness Clinical Evidence11 In 50 patients with hyperkeratotic diseases (psoriasis, chronic eczema, palmoplantar keratoderma, ichthyosis and xerosis). Treatment with Ureadin®Ultra30 significantly reduces scaling, itching, erythema, TEWL and dermal thickness. Improves hydration with very good tolerability.11

Ureadin® Ultra20

Anti-roughness Cream With 20% Urea Isdin® Rough skin Reduces roughness: thanks to Urea Isdin’s® exfoliating action.12 Intensely hydrates and restores the cutaneous barrier reducing areas of extreme dryness.12 Helps to improve skin elasticity.12 Ureadin®Ultra20 contains Urea Isdin® which has demonstrated efficacy in improving: • keratinocyte differentiation1 • the skins barrier function1 • elastin and collagen expression3 • the cellular rejuvenation process12

Method for use: 1 or 2 times daily.

Main indications12 Psoriatic skin lesions Rough skin Mild hyperkerototi states Keratosis pilaris

Ureadin Ultra20

Epidermis before treatment

Anti-roughness Cream With 20% Urea Isdin® Rough skin “Ureadin Ultra20 has allowed for recovery of the anatomical conditions and physiological structures of the skin and, presumably, optimal restoration of the cutaneous barrier.” Pellacani12

Keratinocytes with irregular borders and loss of normal beehive architecture.

Epidermis after 30 days of treatment

Clinical Evidence In patients with chronic irritative dermatitis of the hands12 Reduction in hyperkeratosis - 72% in thickness. From 14.52 to 5.62 μm, measured by optical coherence tomography, OCT. Reduction in the thickness of the corneal layer - 35% in thickness From 142.4 to 92.1 μm evaluated by OCT. Restoration of the normal appearance of keratonocyte edges. Resotration of architecture comparable to healthy skin (evaluated by reflective confocal microscopy, RCM).

The border of the keratinocytes appears normal and the architecture is comparable to healthy skin.

Ureadin Ultra10

Main indications Xerosis Ichthyosis14 Senile skin Scaling and skin conditions due to scratching Itching due to dehydration

Repairing Lotion Plus With 10% Urea Isdin® Very dry and scaly skin Restorative adjuvant treatment of barrier function abnormalities Adjubant in the treatment of the signs of xerosis and ichthyosis14 Helps relieve itching and irritation Restores the skin’s barrier function Intense moisturing (With Urea Isdin® and Despanthenol)13 Reduces the trans-epidermal loss of water (TEWL)13 Ureadin®Ultra10 Lotion Plus is the preferred adjuvant in the treatment of pathologies involving alterations of: • AMP’s (antimicrobial peptides) • Structural proteins • Collagen

Method for use: 1 or 2 times daily.

Ureadin Ultra10

Reduction of xerosis

Repairing Lotion Plus Adjuvant in the treatment of xerosis with prutitus15 The quality of life for patients with chronic kidney failure can be negatively impacted by xerosis and uremic pruritus.15

Reduction of xerosis

Clinical Evidence Ureadin®Ultra10 Lotion Plus* helps reduce xerosis by 82% and pruritus by 94% in ESRD patients (end-stage renal disease).15

T0 *Applied twice daily.

T28

Open-label prospective study of 15 patiens with end-stage renal failure (chronic renal failure stage in dialysis for at least 3 years on the reduction of xerosis and uremic pruritus after using Ureadin®Ultra10 Lotion Plus twice daily for 4 weeks.15

Ureadin® Ultra10

Repairing Lotion Plus Adjuvant in the treatment of ichthyosis14 The patient with ichthyosis presented with aqueous xerosis, intense scaling and pruritus.

Clinical Evidence Ureadin®Ultra10 Lotion Plus has shown to be significantly more effective (p = 0.0001) as a coadjuvant therapy in the treatment of the signs of ichthyosis compared with standard glycerin-based emmolients.14

Ureadin®Ultra10 Lotion Plus has demonstrated evidence in:14 Most effedtive adjuvant in the treatment of ichtyosis vulgaris Decrease of scaling, roughness, redness and cracks A: Ureadin®Ultra10 Lotion Plus. B: Glycerin-based emolient.

References 1.

Grether-Beck S, et al.: Urea revisited: a well-known molecule with previously unrecognized gene regulatory properties. Int J Cosmet Sci. 2009;31(4):309.

2. Grether-Beck S, et al.: Urea acts on the dermis via induction of collagen expression. Presented to 18th Congress of the European Academy of Dermatology and Venereology. Berlin. 2009. 3. Piraccini BM, Starace M: Urea 40 % in a new vehicle (gel-oil) for nail and plantar diseases. Data on file. 4. Raab WP. Uses of urea is cosmetology. Cosmetics and Toliletries. 1990; 105: 97-103. 5. Elewski BE et al. The use of 40 % urea cream in the treatment of moccasin tinea pedis. Cutis. 2004; 73(5):355-7.7. 6. Kligman AM. Dermatologi uses of urea. Acta Derm Venerol 1957; 37(2): 155-159. 7. Martins JE et al. In vitro sensitivity of dermatophytes to urea. Clinics. 2006; 61(1): 9-14. 8. Gemma Marquez Balbas et al. Urea a altas concentraciones: empleo en dermatologfa. Piel. 2008; 23(4 9. Shemer A et al. Treatment of scalp seborrheic dermatitis and psoriasis with an ointment of 40 % urea and 1 % bifonazole. Int J Dermatol. 2000; 39(7): 532-4. 10. 14th EADV London 2005. Clinical and bioengineering evaluation of the efficacy and safety of 30 % urea cream in the treatment of hyperqueratotic skin disorder. J. Molinerol, R. Ojedal, J.Coll2, A Mirada2,C. Trullas2, C. Pelejero2, M.Sanchez Reganal. 11. 64TH AAD San Francisco 2006. Usefulness of 30 % urea cream in hyperkeratotic skin disorders. A clinical and biophysical evaluation. M.Sanchez Reganal. R. Ojedal, J. Molinerol, J.Coll2, A Mirada2,C. Trullas2, C. Pelejero2. 12. Pellacani et al. Dermatite da contatto: effetti cutanei indotti da applicazione di una crema a base di urea. HighTecDermo Journal (pending to publish HighTecDermo Journal). 13. D’Agostino R, Coll J:Urea +Panthenol project. Data on file. 14. Tadini G, et al. Efficacy of topical 10 %. urea-based lotion in patients with ichthyosis vulgaris: a two-center, randomized, controlled, single-blind, right-vs.-left study in comparison with standard glycerol-based emollient cream. Current Medical Research & Opinion. 2011; 27(12):1-6. 15. Castello M, Milani M: Efficacy of topical hydrating and emollient lotion containing 10 % Urea ISDIN plus dexpanthenol (Ureadin Rx 10) in the treatment of skin xerosis and pruritus in hemodialyzed patients: An open prospective pilot trial. Giornale italiano di Dermatologia. 5, 2011. In press.

Psorisdin® Control Shampoo Helps to reduce scaling and itchy scalp conditions. Helps to reduce recurrence of symptoms. Effective, tolerable and cosmetically favourable compared to Coal Tar Shampoo:1 • Proven to reduce the itchiness and soreness associated with scalp psoriasis1 • Comparable efficacy for control of erythema, scale reduction and infiltrating lesions1 Compliant texture: A cosmetically outstanding shampoo Provides a hair conditioning effect for maximum comfort and ease of brushing How to use: Apply the product on wet hair and massage until foam forms Wait for a few minutes, then rinse well. Repeat 3 to 4 times per week

Psorisdin® Control Shampoo Itchiness? Drastic reduction after just 4 weeks2 Gradual reduction and relief of itchiness from the first application

Clinical efficacy, proven results. Endorsed by dermatologists. Tested on 27 consumers under dermatological supervision.

Excellent cosmetic properties 3 Good smell 3 Hair is easy to brush 3 Leaves hair shiny 3 Easy to rinse out 3 Frizz-free hair 3 Softer hair *ISDIN internal user tests

Psorisdin Control Shampoo ®

Greater efficacy thatn 4% coal tar shampoo to reduce itching and burning Equivalent efficacy to control erythema, flaking and infiltration.

Scalp Psoriasis It is estimated that 50% of patients that has dry scalp conditions, develop plaque-like lesions, often with flaky skin and redness which can lead to a negative impact on a person’s quality of life.

Active Ingredients: Descaling and exfoliating: Glycolic Acid 3%, Salicylic Acid 3% Antiproliferative, keratolytic and anti-inflammatory: Icthyol Pale 1,5% Antipruritic: Laureth-9 Moisturising and keratoregulator: Urea ISDIN® 5%

Comparative study with 4% coal tar shampoo.3,4 Results in only 8 weeks

Better cosmetic qualities than 4% coal tar shampoo • Scent • Combing ease

• Hair softness • Shine

Psorisdin® Control Shampoo Clinical Eficence Efficacy of Psorisdin® shampoo in the treatment of scalp psoriasis: A video-dermoscopy evaluation prospective study in 70 patients.2 Evolution of VSCAPSI

The study demonstrated that Psorisdin® Shampoo is welltolerated and effective in the control of flaking and itching and leads to a significant clinical reduction of psoriatic alterations on the scalp, as demonstrated by videodermoscopy.

Percentage of patients reporting pruritus

A Single-centre, prospective, open study with 70 patients affected by moderate/severe intensity scalp psoriasis. Evaluated clinical effecacy by videodermoscopy (VSCAPS/score) and tolerability (pruritus VAS) of Psorisdin® Shampoo used 3 times a week for 12 weeks with controls at baseline after 45 and 90 days. 1. Sánchez Regaña M, Dilmé M, Mirada A, et al. Increased efficacy and acceptabiility of a non-coaltar shampoo for scalp psoriasis: better efficacy and acceptability. Poster. 67th AAD San Francisco 2009. 2. Alfredo Rossi MD et al. Efficacy of Iralfaris shampoo in the treatment of scalp psoriasis: A videodermoscopy evaluation prospective study in 70 patients.G ITAL DERMATOL VENEREOL 2012;147:1-2. 3. Sanchez Regaña M, Dilmé E, Mirada A, et al, Increased efficacy and acceptability of a non-coal tar shampoo for scapl psoriasis: better efficacy and acceptability. Abstract accepted in 67th Annual meeting of the American Academy of Dermatology and Venereology. ADD. (San Francisco 2009) 4. Sanchez Regaña M, Dilmé E, De la Cruz, G, et al. Treatment of scalp psoriasis with a non-coal tar shampoo: excellent cosmetic results with no loss of effectiveness. Presentado en 17 Congress of European Academy of Dermatology and Venereology, EADV. (Paris 1008). Distributed by: Glenmark Pharmaceuticals South Africa (Pty) Ltd. First floor, Block A, 34 Monte Carlo Crescent, Kyalami Park, Midrand, 1684. Tel: (011) 564 3900. www.glenmarkpharma.co.za ISDINPCS31/07/2020

Nutradeica®

HELP OFFER PEOPLE WITH SEBORRHOEIC DERMATITIS AN ENHANCED QUALITY OF LIFE

FACIAL GEL CREAM

Proven efficacy in seborrhoeic dermatitis:1 Helps to reduce: 3 Flaking 3 Itching 3 Redness

Helps to regulate sebum Promotes a matte complexion Works from the very first application:2

81% less scaling

61% less itching

59% less redness

ISDIN Nutradeica® posesses antifungal and antiinflammatory properties in the treatment of seborrhoeic dermatitis, demonstrated with innovative ex vivo models.3

ANTI-INFLAMMATORY PROPERTIES Evaluation of pro-inflammatory cytokines (IL-8 and TNF-α)

ANTIFUNGAL PROPERTIES Ex vivo model of SD in human skin explants

Skin explant (control group)

Skin explant colonised with Malassezia furfur

TREATMENT WITH Nutradeica® FACIAL GEL CREAM

Ketoconazole 2% Cream

Nutradeica® Facial Gel Cream achieved a reduction in the growth of Malassezia furfur vs. ketaconazole 2% cream

Nutradeica® Facial Gel demonstrated anti-inflammatory properties similar to hydrocortisone 1% cream

Nutradeica® FACIAL GEL CREAM

Clinically proven effiacy in patients with moderate-to-severe seborrhoeic dermatitis on the face and chest4

Nutradeica® Facial Gel Cream Main Ingredients and Properties5 Ingredients

Property

Piroctone olamine

Antifungal

Stearyl glycyrrhetinate

Anti-inflammatory

Zinc pidolate

Sebo-regulating

Acetamide MEA

Kerato-regulating, conditioning agent

Biosaccharide gum-2

Antifungal Anti-inflammatory, soothing, helps attenuate inflammatory reactions in the skin

Pentylene glycol + butylene glycol + hydroxyphenyl propamidobenzoic acid

Anti-irritant, anti-itch, anti-histaminic

Polymethyl methacrylate

Hydrator and moisturisation enhancer

Nutradeica® Facial Gel Cream helps to improve quality of life in people with mild seborrhoeic dermatitis6

IMPROVEMENT OF THE QUALITY OF LIFE on a functional, emotional and symptomatic level, according to SKINDEX-29 D0 D28

Clinical evaluation of seborrhoeic dermatitis: an integrated management approach7 CLINICAL EVALUATION

Managing both the active phase as well as maintenance of seborrhoeic dermatitis by incorporating Nutradeica® Facial Gel Cream. It is intended to help decrease the use of medications with potential side effects, as well as to minimise and prevent outbreaks. References: 1. Valderas-Martinez P, et al. Poster presented at SDPA Meeting, San Diego, CA, June 2017. 2. Clinical study for the evaluation of the efficacy of Nutradeica® Gel Cream in the treatment of mild SD (33 patients), 2009. Data on file. 3. Granger, C., Balato, A., Goñi-de-Cerio, et al. (2019). Novel Non-Steroidal Facial Cream Demonstrates Antifungal and Anti-Inflammatory Properties in Ex Vivo Model for Seborrheic Dermatitis. Dermatology and therapy, 9(3), 571–578. https://doi.org/10.1007/s13555-019-0311-4. 4. Balato, A., Caiazzo, G., Di Caprio, R., et al. (2020). Exploring Anti-Fungal, Anti-Microbial and Anti-Inflammatory Properties of a Topical Non-Steroidal Barrier Cream in Face and Chest Seborrheic Dermatitis. Dermatology and therapy, 10(1), 87–98. https://doi.org/10.1007/s13555-019-00339-w 5. ISDIN Data on File. 6. Piquero-Casals J, et al. Seborrheic dermatitis and quality of life: Evaluation of a facial gel-cream formulated with Zinc PCA, Piroctone olamine, Dihydro avenanthramide and Es-tearylglycyretinate. Poster presented at 46th AEDV. Palma de Mallorca. 2018 7. Piquero-Casals J, et al. Topical Non-Pharmacological Treatment for Facial Seborrheic Dermatitis. Dermatol Ther (Heidelb). 2019;9(3):469–477. Distributed by: Glenmark Pharmaceuticals South Africa (Pty) Ltd, 2nd Floor, Building D, Stoneridge Office Park, 8 Greenstone Place, Greenstone, Edenvale, Gauteng, 1609. Tel: (011) 564 3900. www.glenmarkpharma.co.za

NEW Nutratopic® PRO-AMP

Extended control for atopic skin

Atopic Dermatitis The problem:

Atopic Dermatitis is a skin condition with disruptive symptoms which leads to an inflammatory cycle. Atopic Dermatitis (AD) is triggered by: • Alterations in the cutaneous barrier1 • Altered barrier function • Immune deficiency • Increased transepidermal water loss (TEWL)2 Xerosis, Itching • Greater permeability to pathogenic substances and allergens3 Inflammation • Increased bacterial adhesion and proliferation (Staphylococcus aureus)4 Microbial infections

Nutratopic® PRO-AMP Solution The Nutratopic® Pro-AMP product range, is developed to relieve these symptoms, effectively breaking the cycle:5 Double active protection Restores the skin barrier, reinforcing the lipid mantle: Ceramides, Omega-6 Reinforces the skin’s immune system defense: Pro-AMP L-lsoleucine • Deep hydration Glycerin • Relieves itching and prevents scratching Polidocanol • Reduces inflammation Niacinamid • Reduces risk of bacterial adhesion Rhamnosoft

Nutratopic® PRO-AMP Facial Facial Cream Active protection of the skin’s defence system • Helps reinforce the skin’s innate immune defence system6,7,8,9 L-lsoleucine • Optimal absorption, facilitating compliance DMS lamellar structure that mimics the skin (Derma Membrane Structure) • Reduces risk of bacterial adhesion10 Rhamnosoft Directions for use: Apply twice daily as adjuvant to control the symptoms and as maintenance during remission periods.

L-Isoleucine Stimulates the production of Antimicrobial Peptides (AMPs).6,7 AMPs are the components of the skin’s innate immune system with powerful antimicrobial and antiviral properties.8,9

Rhamnosoft Rhamnosoft binds to the keratinocyte cell membrane and inhibits bacterial adhesion.10

Nutratopic® PRO-AMP Facial

Nutratopic® Pro-AMP facial cream reduces the ESS by 84% vs a 50% reduction with a standard emollient cream11

Clinical Evidence

D28

Child (3 month old infant) usind only Nutratopic® Pro-AMP Facial for 4 weeks

D14

Child (2 month old infant) usind only Nutratopic® Pro-AMP Facial for 4 weeks Results in 107 children11

The Eczema Severity Score (ESS) measures severity of outbreaks according to erythema, thickness, itching and skin lichenification. Evaluation from 0 (none) to 3 (severe). Study characteristics n=107, average age 5-6 years old, Randomised, Multicentre, evaluatorblind.

Nutratopic® PRO-AMP Specific Areas Emollient Cream

Specific areas require daily maintenance and control

Active protection of the skin’s defence system • Restores barrier function5 Ceramides, Omega-6, Glycerin • Helps reinforce the skin’s innate immune defence system6,7,8,9 L-lsoleucine • Relieves itching5 Polidocanol • Reduces inflammation5 Niacinamide • Reduces risk of bacterial adhesion10 Rhamnosoft

Directions for use: Apply twice daily or as needed on specific areas as adjuvant to control the symptoms and as maintenance during remission periods.

In damaged areas in atopic skin there is subclinical inflammation even during remission periods. Intense, daily and continuous care of these areas is necessary to prevent new outbreaks. Texture provides immediate comfort and deep hydration, reinforcing the lipid mantle.

Nutratopic® PRO-AMP Body Emollient Bath Gel Soft hygiene and specific protection without itching • Helps reinforce the skin’s innate immune defence system6,7,8,9 L-lsoleucine • Relipidising 18% emollient oils • Reduces risk of bacterial adhesion10 Rhamnosoft • Optimal pH maintenance 6.01 vs. 6.35 • Hygiene with a specific syndet reduces the severity of eczematous lesions and maintains hydration in patients with AD Directions for use: Apply daily to damp skin in the bath or shower and rinse.

Nutratopic® PRO-AMP Body Emollient Lotion Deep hydration for larger areas of the skin • Helps reinforce the skin’s innate immune defence system6,7,8,9 L-lsoleucine • Restores barrier function5 Ceramide 3 and other emollients • Relieves itching5 Polidocanol • Reduces risk of bacterial adhesion10 Rhamnosoft

Directions for use: Apply daily on large areas of clean and dry skin.

Holistic approach

Nutratopic® PRO-AMP A specific product line for proactive care, during the AD cycle

Ureadin® Podos Gel Oil

Repairs and Hydrates Dry and Cracked Feet Eliminates roughness, hard skinand moderate thickening. One of the most important, complex and delicate parts of the human body Due the strain of our body weight and our daily lifestyle, feet are constantly exposed to: • Stress and external aggressions. • Lack of ventilation. • Changes in temperature. • Chafing and accidental bumps All of this can lead to very common alterations on the soles of the feet and heels: • Dry and rough skin. • Thickened skin and calluses. • Yellow colour. • Flaking. • Cracks due to dryness. • Hyperkeratosis (calluses). • Mycosis (fungi).

Ureadin® Podos Gel Oil

Repairs and Hydrates Dry and Cracked Feet With Urea Isdin® 10% Repairs cracks due to dryness:1 Thanks to re-epithelialising ingredients (Allantoin, Panthenol) and emollients (Shea Butter). Eliminates roughness, hard skin and moderate thickening:1 Due to the exfoliating action of Lactic Acid and Bacillus ferment. Hydrates intensely for 24h:2 Urea Isdin® retains water, providing an optimal level of hydration. Gel Oil Texture: Fresh, light, non-greasy texture with rapid absorption that facilitates daily use and maximises product efficacy. Main Indications: • Cracks. • Flaking. • Calluses. • Dryness. Well-tolerated in 100 % of cases.1,3,4,5

Results Urea Isdin® •

Basic foot care recommendations • • •

• •

Wash your feet once a day, with antiseptic acidic soap (pH 5.5) and warm water. Dry them carefully, especially between the toes. Keep foot skin well moisturised. Heels are the area of the feet which need the most hydration. To avoid cracks due to dryness, apply a moisturising product with Urea, adapted to the condition of your feet. Trim your toenails straight and not too short. It is advisable to file them. See a specialist if you have any pain, redness, itching between your toes, flaking, etc.

• •

•

An active molecule that penetrates the skin’s layers, stimulating physiological regeneration mechanisms. Moisturising and exfoliating effects. Stimulates formation of the skin barrier, reinforcing the skin’s immune system. Promotes collagen synthesis.

Using a moisturising product with Urea Isdin® promotes adequatefoot hydration and prevents appearance of roughness, thickening or cracks.

Glenmark Pharmaceuticals South Africa (Pty) Ltd 2nd Floor, Building D, Stoneridge Office Park 8 Greenstone Place, Greenstone, Edenvale, Gauteng, 1609. Tel: (011) 564 3900 www.glenmarkpharma.co.za