MATERIAL SAFETY DATA SHEET Sertraline Hydrochloride Tablets, USP Effective Date: 14-Sep-2012

Section 1 - Chemical Product and Company Manufacturer:

Emergency Phone:

InvaGen Pharmaceuticals Inc 7, Oser Avenue Hauppauge, NY 11788

1-631-231-3233

Common Name: Sertraline Hydrochloride Tablets Synonym(s): Not found Chemical Name: (1S-cis)-4-(3,4,-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine Chemical Family: Selective serotonin reuptake inhibitor (SSRI) Trade Name(s): Sertraline Hydrochloride Tablets, USP 25 mg, 50 mg and 100 mg. Therapeutic Category: Antidepressant, Anti obsessional, antipanic agent Molecular formula and weight: C17H17Cl2N.HCl and Wt: 342.70

Section 2 - Composition / Information on Ingredients Ingredient Sertraline Hydrochloride Excipients

CAS

Concentration %

79559-97-0

37 – 38 %

NA

62 – 63 %

Contains no hazardous components (one percent or greater) or carcinogens (one-tenth percent or greater) not listed above. Exposure Guidelines: Not Found Page 1 of 9

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Section 3 - Hazards Identification Not considered hazardous when handled under normal conditions.

Emergency Overview Emergency Overview Effective Date: 14-Sep-2012 InvaGen Laboratory Labeling Codes: Health 1 Flammability 0 Reactivity 0 Primary Physical and Health Hazards: Not hazardous if intact. Caution Statement: Harmful if swallowed. Very toxic to aquatic life.

Routes of Entry: Oral Effects of Overexposure: Tablets are intended for human consumption under guidance of a physician. Intact tablets are not considered hazardous under normal handling procedures. Human Experience Of 1,027 cases of overdose involving sertraline hydrochloride worldwide, alone or with other drugs, there were 72 deaths (circa1999). Among 634 overdoses in which sertraline hydrochloride was the only drug ingested, eight resulted in fatal outcome, 75 completely recovered and 27 patients experienced sequelae after over dosage to include alopecia, decreased libido, diarrhea, ejaculation disorder, fatigue, insomnia, somnolence and serotonin syndrome. The remaining 524 cases had an unknown outcome. The most common signs and symptoms associated with nonfatal sertraline hydrochloride over dosage were somnolence, vomiting, tachycardia, nausea, dizziness, agitation and tremor. The largest known ingestion was 13.5 grams in a patient who took sertraline hydrochloride alone and subsequently recovered. However, another patient who took 2.5 grams of sertraline hydrochloride alone experienced a fatal outcome. Other important adverse events reported with sertraline hydrochloride overdose (single or multiple drugs) include bradycardia, bundlebranch block, coma, convulsions, delirium, hallucinations, hypertension, hypotension, manic reaction, pancreatitis, QT-interval prolongation, serotonin syndrome, stupor and syncope. Note: This document has been prepared in accordance with standards for workplace safety, which require the inclusion of all known hazards of the active substance or its intermediates regardless of the potential risk. The precautionary statements and warnings included may not apply in all cases. Your needs may vary depending upon the potential for exposure in your workplace. Page 2 of 9

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Section 4 - First Aid Measures In case of Inhalation: Remove to fresh air. If not breathing give artificial respiration. If breathing is difficult give oxygen. Obtain medical attention. In case of contact with Skin: Remove contaminated clothing. Flush area with large amounts of water. If irritation persists, seek medical attention. In case of contact with Eyes: Flush with water while holding eyelids open for at least 15 minutes. Seek medical attention immediately. In case of Ingestion: Never give anything by mouth to an unconscious person. Wash out mouth with water. Do not induce vomiting unless directed by medical personnel. Seek medical attention immediately. Overdose Management: Treatment should consist of those general measures employed in the management of overdosage with any antidepressant. Ensure an adequate airway, oxygenation and ventilation. Monitor cardiac rhythm and vital signs. General supportive and symptomatic measures are also recommended. Induction of emesis is not recommended. Gastric lavage with a large-bore orogastric tube with appropriate airway protection, if needed, may be indicated if performed soon after ingestion or in symptomatic patients. Activated charcoal should be administered. Due to large volume of distribution of this drug, forced diuresis, dialysis, hemoperfusion and exchange transfusion are unlikely to be of benefit. No specific antidotes for sertraline are known. In managing overdosage, consider the possibility of multiple drug involvement. The physician should consider contacting a poison control center on the treatment of any overdose. Telephone numbers for certified poison control centers are listed in the Physicians „Desk Reference® (PDR®).

Section 5 - Fire Fighting Measures Flash Point: No applicable information found Extinguishing Media: Water spray, dry chemical powder, carbon dioxide or foam as appropriate for surrounding fire and materials. Fire and Explosion Hazards: This material is assumed to be combustible. May emit toxic fumes of carbon monoxide, carbon dioxide, nitrogen oxides, hydrogen chloride and other chlorine-containing compounds.

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Section 6 - Accidental Release Measures The following are recommended for manufacturing or other situations where exposure to the tablet powder may occur. Spills: Vacuum material with appropriate dust collection filter in place. Be aware of potential for dust explosion when using electrical equipment. If vacuum is not available, lightly mist material and remove by sweeping or wet wiping. Wear protective equipment, including eye protection, to avoid exposure (see Section 8 for specific handling precautions). Place spills in appropriately labelled container for disposal.

Section 7 - Handling and Storage Handling: Avoid all contact and inhalation of dust, mists, and/or vapors associated with the material. Wash thoroughly after handling. Avoid contact with eyes. Handle and store as per the label to ensure product integrity. Storage Conditions: Controlled Room Temperature: 20º to 25º C (68º to 77º F). Store the medicine in a tight, light resistant container at room temperature; keep away from heat and source of ignition, moisture, and direct light.

Section 8 - Exposure Controls / Personal Protection See Section 2 for Exposure Guideline information. Coated compressed tablets are not considered hazardous under normal handling procedures and protective equipment is not required. The following are recommended for manufacturing or other situations where exposure to the powder may occur. Respiratory Protection: Use a NIOSH approved respirator or an alternate approved dust mask should be used. Eye Protection: Safety goggles or glasses. Ventilation: Laboratory fume hood or local exhaust ventilation. Other Protective Equipment: Chemical-resistant gloves and body covering to minimize skin contact. If handled in a ventilated enclosure, as in a laboratory setting, respirator and goggles or face shield may not be required. Safety glasses are always required. Additional Exposure Precautions: In production settings, airline-supplied, hood-type respirators are preferred. Shower and change clothing if skin contact occurs.

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Section 9 - Physical and Chemical Properties Appearance: 25 mg Tablets : Light Green, film coated, modified oval biconvex tablets de-bossed with „I‟ on the left side of bisect and „G‟ on the right side of bisect on one side and “212” on other. 50 mg Tablets : Light Blue, film coated, modified oval biconvex tablets de-bossed with „I‟ on the left side of bisect and „G‟ on the right side of bisect on one side and “213” on other. 100 mg Tablets : Light Yellow, film coated, modified oval biconvex tablets, de-bossed with „I‟ on the left side of bisect and „G‟ on the right side of bisect on one side and “214” on other. Physical State: Solid (Tablets) Boiling Point: No applicable information found Melting range: No applicable information found Specific Gravity: No applicable information found pH: No applicable information found Evaporation Rate: No applicable information found Water Solubility: Soluble Vapor Density: No applicable information found Vapor Pressure: No applicable information found

Section 10 - Stability and Reactivity Stability: Stable at normal temperatures and pressures. Incompatibility: No applicable information found. Hazardous Decomposition: When heated to decomposition material emits toxic fumes of CO/NO2, HCl and NOx on combustion. Emits toxic fumes under fire conditions. Hazardous Polymerization: No applicable information found.

Section 11 - Toxicological Information Sertraline Hydrochloride: Oral Rat male

: LD50

: 1591 mg/kg

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Oral Rat Female

: LD50

: 1327 mg/kg

Oral Mouse Male

: LD50

: 548 mg/kg

Oral Mouse Female

: LD50

: 419 mg/kg

Irritancy data : No applicable information found Corrosivity: No applicable information found Reproduction: Teratogenic Effects. Pregnancy Category C Reproduction studies have been performed in rats and rabbits at doses up to 80 mg/kg/day and 40 mg/kg/day, respectively. These doses correspond to approximately 4 times the maximum recommended human dose (MRHD) on a mg/m2 basis. There was no evidence of teratogenicity at any dose level. When pregnant rats and rabbits were given sertraline during the period of organogenesis, delayed ossification was observed in fetuses at doses of 10 mg/kg (0.5 times the MRHD on a mg/m2 basis) in rats and 40 mg/kg(4 times the MRHD on a mg/m2 basis) in rabbits. When female rats received sertraline during the last third of gestation and throughout lactation, there was an increase in the number of stillborn pups and in the number of pups dying during the first 4 days after birth. Pup body weights were also decreased during the first 4 days after birth. These effects occurred at a dose of 20 mg/kg (1 times the MRHD on a mg/m2 basis). The no effect dose for rat pup mortality was 10 mg/kg (0.5 times the MRHD on a mg/m2 basis). The decrease in pup survival was shown to be due to in utero exposure to sertraline. The clinical significance of these effects is unknown. There are no adequate and well controlled studies in pregnant women. Sertraline hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. A decrease in pregnancy rate was seen in rats (Fo generation) when this material was given at oral doses of 10, 40 or 80 mg/kg/day. No effects of fertility or reproductive performance of F1 exposed in utero, not were there my effects on their F2 offspring. Peri and postnatal development study inrats at doses upto 80 mg/kg/day showed a decrease in mean litter size andl itter weight, and delays ill postnatal development of pups. Mutagenicity: Sertraline had no genotoxic effects, with or without metabolic activation, based on the following assays: bacterial mutation assay; mouse lymphoma mutation assay; and tests for cytogenetic aberrations in vivo in mouse bone marrow and in vitro in human lymphocytes. Chronic Exposure: Chronic toxicity was evaluated in rat at dose levels up to 40mg/kg/day for 2 years. High dosed animals showed terminal mean body weight differences, elevated serum transaminase values after 6 months, increased liver and kidney to body ratios, and singlecell hepatic vacuolation. A one-year oral study in dogs at doses up to 30 mg/kg/day showed dose-related CNS and ANS clinical signs at high doses. Page 6 of 9

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Impairment of Fertility: A decrease in fertility was seen in one of two rat studies at a dose of 80 mg/kg (4 times the maximum recommended human dose on a mg/m2 basis). Carcinogenesis: Lifetime carcinogenicity studies were carried out in CD-1 mice and Long-Evans rats at doses up to 40 mg/kg/day. These doses correspond to 1 times (mice) and 2 times (rats) the maximum recommended human dose (MRHD) on a mg/m2 basis. There was a dose related increase of liver adenomas in male mice receiving sertraline at 10 to 40 mg/kg (0.25 to 1 times the MRHD on a mg/m2basis). No increase was seen in female mice or in rats of either sex receiving the same treatments, nor was there an increase in hepatocellular carcinomas. Liver adenomas have a variable rate of spontaneous occurrence in the CD-1 mouse and are of unknown significance to humans. There was an increase in follicular adenomas of the thyroid in female rats receiving sertraline at 40 mg/kg(2 times the MRHD on a mg/m2 basis); this was not accompanied by thyroid hyperplasia. While there was an increase in uterine adenocarcinomas in rats receiving sertraline at 10 to 40 mg/kg (0.5 to 2 times the MRHD on a mg/m2 basis) compared to placebocontrols, this effect was not clearly drug-related. Target Organ Effects: Central Nervous System, Cardiovascular System Respiratory System and gastrointestinal tract. Sensitization: No applicable information found.

Section 12 - Ecological Information No applicable information found.

Section 13 - Disposal Considerations Waste Disposal: Dispose of any cleanup materials and waste residue according to all applicable laws and regulations.

Section 14 - Transport Information Regulatory Organizations: DOT: Not Regulated ICAO/IATA: Not Regulated IMO: Not Regulated

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Section 15 - Regulatory Information Below is selected regulatory information chosen primarily for possible InvaGen and Company usage. This section is not a complete analysis or reference to all applicable regulatory information. Please consider all applicable laws and regulations for your country/state. U.S. Regulations Sertraline Hydrochloride: TSCA - No CERCLA - Not on this list SARA 302 - Not on this list SARA 313 - Not on this list OSHA Substance Specific - No OSHA Label: WARNING Harmful if swallowed. Very Toxic to aquatic life. E.U. Regulations EU Symbol: Xn, N EU Indication of danger: Harmful Dangerous for the Environment EU Risk Phrases: R22 - Harmful if swallowed. R50 - Very toxic to aquatic organisms. EU Safety Phrases: S22 - Do not breathe dust. S57 - Use appropriate containment to avoid environmental contamination.

Section 16 - Other Information MSDS Sections Revised: Revision-01 As of the date of issuance, we are providing available information relevant to the handling of this material in the workplace. All information contained herein is offered with the good faith belief that it is accurate. THIS MATERIAL SAFETY DATA SHEET SHALL NOT BE DEEMED TO CREATE ANY WARRANTY OF ANY KIND (INCLUDING WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE). In the event of an adverse incident associated with this material, this safety data sheet is not intended to be a substitute for consultation with appropriately trained personnel. Nor is this safety data sheet intended to be a substitute or product literature which may accompany the finished product.

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GLOSSARY: CAS Number = Chemical Abstract Service Registry Number CERCLA = Comprehensive Environmental Response Compensation and Liability Act (of 1980) DOT = Department of Transportation IARC = International Agency for Research on Cancer ICAO/IATA = International Civil Aviation Organization/ International Air Transport Association IMO = International Maritime Organization MSDS = Material Safety Data Sheet NA = Not Applicable NIOSH = National Institute for Occupational Safety and Health OSHA = Occupational Safety and Health Administration PDR = Physicians Desk Reference SARA = Superfund Amendments and Reauthorization Act SSRI’s = Selective serotonin reuptake inhibitor TSCA = Toxic Substances Control Act

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