3.1. Substances Not applicable 3.2. Mixtures Name Product identifier % Classification according to Directive 67/548/EEC

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1 Date of issue: 01/05/2015 Revision date: 01/05/2015 Version: 2.0 SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1. Product identifier Chemical type Trade name SDS CODE Other means of identification : Mixture : COMPRESSOL SM : E054 : A mixture of Non-hazardous Polyol with less than 2% silicates 1.2. Relevant identified uses of the substance or mixture and uses advised against Relevant identified uses Use of the substance/preparation : Pharmaceutical Excipient/Binder Uses advised against 1.3. Details of the supplier of the safety data sheet SPI Pharma Chemin du Vallon du Maire Septemes - France T F CBlasquez@spipharma.com SECTION 2: Hazards identification 2.1. Classification of the substance or mixture Classification according to Regulation (EC) No. 1272/2008 [CLP] Not classified Classification according to Directive 67/548/EEC or 1999/45/EC Not classified Adverse physicochemical, human health and environmental effects 2.2. Label elements Labelling according to Regulation (EC) No. 1272/2008 [CLP] No labelling applicable Labelling according to Directive 67/548/EEC or 1999/45/EC No labelling applicable 2.3. Other hazards SECTION 3: Composition/information on ingredients 3.1. Substances Not applicable 3.2. Mixtures Name Product identifier % Classification according to Directive 67/548/EEC Non-hazardous polyol A (CAS No.) Proprietary Not classified Non-hazardous polyol B (CAS No.) Proprietary Not classified silicon dioxide (CAS No.) (EC no) < 2 Not classified Name Product identifier % Classification according to Regulation (EC) No. 1272/2008 [CLP] Non-hazardous polyol A (CAS No.) Proprietary Not classified Non-hazardous polyol B (CAS No.) Proprietary Not classified silicon dioxide (CAS No.) (EC no) Full text of R-, H- and EUH-phrases: see section 16. SECTION 4: First aid measures 4.1. Description of first aid measures First-aid measures after inhalation < 2 Not classified : If respiratory irritation occurs upon inhalation, remove to fresh air. Seek medical attention if symptoms develop or persist. 01/05/2015 EN (English) 1/5

2 First-aid measures after skin contact First-aid measures after eye contact First-aid measures after ingestion : Wash skin with plenty of water and soap. Seek medical attention if irritation develops. : Immediately rinse with plenty of water. If eye irritation persists: Get medical advice/attention. : If swallowed, seek medical advice immediately and show this container or label. Do not induce vomiting. Never give anything by mouth to an unconscious person Most important symptoms and effects, both acute and delayed Symptoms/injuries after inhalation Symptoms/injuries after skin contact Symptoms/injuries after eye contact Symptoms/injuries after ingestion : Overexposure may be irritating to the respiratory system. : Repeated or prolonged skin contact may cause irritation. : Direct contact with the eyes is likely irritating Indication of any immediate medical attention and special treatment needed Treat symptomatically. SECTION 5: Firefighting measures 5.1. Extinguishing media Suitable extinguishing media: Unsuitable extinguishing media : Ingestion of large amounts may produce some discomfort and gastrointestinal disturbances including a laxative action. : carbon dioxide (CO2), dry chemical powder, foam. Water fog. : Not identified Special hazards arising from the substance or mixture Fire hazard Explosion hazard Reactivity : Material will burn at high temperatures. On combustion forms: Carbon monoxide. Carbon dioxide. : Accumulation of airborne dusts may present an explosion hazard in the presence of an ignition source Advice for firefighters Protective equipment for firefighters : Fully enclosed impervious protective suit with integral or tight-fitting gloves, boots, self-contained or supplied air respirator must be worn. Refer to section 8. SECTION 6: Accidental release measures 6.1. Personal precautions, protective equipment and emergency procedures For non-emergency personnel Protective equipment : Refer to section For emergency responders Protective equipment : Refer to section 8. Emergency procedures 6.2. Environmental precautions Do not flush down sewers. Do not discharge into drains or the environment Methods and material for containment and cleaning up For containment Methods for cleaning up : Avoid generation of dust. Avoid release to the environment. : Contain and collect as any solid. If sweeping of a contaminated area is necessary, use a dust suppressant agent. : Ventilate affected area. Sweep up or vacuum up the product. Use of a moist absorbent is recommended. Avoid raising powdered materials into airborne dust Reference to other sections Refer to sections 8 and 13. SECTION 7: Handling and storage 7.1. Precautions for safe handling Precautions for safe handling : Avoid contact with eyes. Avoid raising powdered materials into airborne dust. Do not breathe dust Conditions for safe storage, including any incompatibilities Storage condition(s) Incompatible materials 7.3. Specific end use(s) Excipient/Binder. : Keep container tightly closed. Store at room temperature. : Strong acid. Oxidizing agents. SECTION 8: Exposure controls/personal protection 8.1. Control parameters silicon dioxide ( ) Austria MAK (mg/m³) 4 mg/m³ (inhalable fraction) 01/05/2015 EN (English) 2/5

3 silicon dioxide ( ) Belgium Limit value (mg/m³) 10 mg/m³ (inhalable fraction) Germany TRGS 900 Occupational exposure limit value (mg/m³) 4 mg/m³ (Inhalable fraction) Italy - Portugal - USA ACGIH ACGIH TWA (mg/m³) 10 mg/m³ (respirable,dust) Spain VLA-ED (mg/m³) 10 mg/m³ (inhalable fraction) United Kingdom WEL TWA (mg/m³) 6 mg/m³ (inhalable fraction) United Kingdom WEL STEL (mg/m³) 2.4 mg/m³ (respirable, dust) 8.2. Exposure controls Appropriate engineering controls Personal protective equipment : Provide adequate ventilation to minimize dust concentrations. : Gloves. Safety glasses. Protective clothing. Hand protection Eye protection Skin and body protection Respiratory protection : In case of repeated or prolonged contact wear gloves. : safety glasses with side-shields. : Use protective coverall. Wear long sleeves. : In case of inadequate ventilation wear respiratory protection. half-mask with filter according to EN 149. SECTION 9: Physical and chemical properties 9.1. Information on basic physical and chemical properties Physical state : Solid Appearance : Powder. Molecular mass : Mixture- Not applicable g/mol Colour : white. Odour : None. Odour threshold ph : Neutral Melting point : Not determined. Solidification point Boiling point : Not determined. C Flash point : Not available Relat. evapor. rate comp. to butylacetate Flammability (solid, gas) : Not applicable Explosive limits Vapour pressure : Not applicable. Relative vapour density at 20 C : Not applicable Relative density Density : Not available Solubility : Water: Soluble Log Pow Self ignition temperature : Not determined. Decomposition temperature Viscosity 9.2. Other information SECTION 10: Stability and reactivity Reactivity No data available Chemical stability Stable Possibility of hazardous reactions Product will not undergo polymerization Conditions to avoid Avoid raising powdered materials into airborne dust. 01/05/2015 EN (English) 3/5

4 10.5. Incompatible materials Oxidizing agents. Strong acid Hazardous decomposition products Carbon monoxide. Carbon dioxide (CO2). low molecular weight hydrocarbons. SECTION 11: Toxicological information Information on toxicological effects ATE (oral) 2000 mg/kg SECTION 12: Ecological information Toxicity LC50 fishes LC50 other aquatic organisms EC50 Daphnia EC50 other aquatic organisms (fish, 96 h) Not tested (micro-organisms, 5 h) Not tested (daphnia, 48 h) Not tested (algae, 72 h) Not tested Persistence and degradability Persistence and degradability Not tested Bioaccumulative potential Bioaccumulative Potential Not tested Mobility in soil Results of PBT and vpvb assessment Results of PBT assessment Other adverse effects Other adverse effects No data available.. SECTION 13: Disposal considerations Waste treatment methods Regional legislation (waste) Waste disposal recommendations SECTION 14: Transport information Not a dangerous good in sense of transport regulations. SECTION 15: Regulatory information : Dispose of contents/container to comply with applicable local, national and international regulations. : Disposal must be done according to official regulations Safety, health and environmental regulations/legislation specific for the substance or mixture EU-Regulations National regulations Chemical safety assessment SECTION 16: Other information Sources of Key data Abbreviations and acronyms : SDS. : ACGIH (American Conference of Governement Industrial Hygienists). ASTM - American Society for Testing and Materials. CAS (Chemical Abstracts Service) number. CLP - Classification, Labelling and Packaging. CSR: Chemical Safety Report. EC - European Community. EEC: European Economic Community. GHS - Globally Harmonised System. IARC (International Agency for Research on Cancer). Overland transport (ADR). PVC (Polyvinyl chloride). REACH - Registration, Evaluation, Authorisation and Restriction of Chemicals. SDS -. 01/05/2015 EN (English) 4/5

5 This information is based on our current knowledge and is intended to describe the product for the purposes of health, safety and environmental requirements only. It should not therefore be construed as guaranteeing any specific property of the product. 01/05/2015 EN (English) 5/5