Product Description
Since last manyyears Saintroy Lifescience is leading manufacture, export and supplierofL-Asparaginase Injection from Surat, Gujarat, India. L-Asparaginase Injectionused as a medication and in food manufacturing.
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ISO/GMP/cGMP/WHOGMP/NAFDAC approved, PPB Kenya approved/USFDA approved/EUGMP approved/MOH Iran approved manufacturingfacility in Gujarat, India.
Registration: Saintroy Lifescience is interested in registrationof own brand or customer brands in ministry of health of clientscountry and we also provide the products samples, COA, COPP, ACTD or CTD dossier, DMF, Manufacturing license, Free sales certificate and other required documents.
Export Country:Saintroy Lifescience L-Asparaginase Injectionexport to USA, Canada, Germany, Europe, France, Ghana, Nigeria,Kenya, Senegal, Sudan,UAE, Kuwait, Dubai, Cameroon, Lebanon, Peru, Chile,Somalia, Philippines, Myanmar, Maldives, Thailand, Singapore, Malaysia, HongKong, China, Zimbabwe, Togo, Burkina Faso, Niger,Guinea Bissau, Congo,Democratic of republic, Ivory Costa, Oman, Guatemala, Nicaragua, Salvador,Qatar, Costa Rica, Panama, Cuba, Colombia, Bolivia, Argentine, Algeria, Guyana,Morocco, Jordan, Bahrain, Iran, Egypt, Kyrgyzstan, Uzbekistan, Kazakhstan.
Superior Protein Purity and SafetyThis L-Asparaginase injection features protein purity greater than 99% as confirmed by SDS-PAGE, ensuring a highly refined product. Endotoxin levels remain below 0.5 EU/mg, minimizing potential adverse immune reactions and offering a high degree of safety for clinical application. Each batch undergoes strict quality control, maintaining consistency and reliability.
Flexible Administration and ReconstitutionAdministered via intravenous or intramuscular routes, this injection is easy to prepare by reconstituting the lyophilized powder with sterile water. For IV infusion, normal saline or 5% dextrose serves as a suitable diluent. The product maintains stability and enzymatic activity across specified pH and temperature ranges, allowing flexibility in clinical settings.
Stringent Quality and Compliance StandardsProduced in facilities compliant with GMP, WHO-GMP, and ISO 9001:2015 certifications, L-Asparaginase injection guarantees pharmaceutical-grade quality. All batches are tested for sterility and potency, supporting safe and effective use for healthcare institutions, wholesalers, and distributors worldwide.
FAQ's of L-Asparaginase Injection:
Q: How should L-Asparaginase Injection be properly reconstituted and administered?
A: Reconstitute the lyophilized powder in sterile water for injection, following the manufacturer's guidance. For intravenous infusion, dilute with normal saline or 5% dextrose. The solution can be administered either intravenously or intramuscularly, depending on clinical judgment.
Q: What are the primary indications and benefits of using L-Asparaginase Injection?
A: L-Asparaginase injection is indicated for the treatment of Acute Lymphoblastic Leukemia (ALL). Its primary benefit lies in its ability to inhibit asparagine-dependent tumor cell growth, forming a critical component of combination chemotherapy protocols for ALL.
Q: When is this product contraindicated?
A: This injection is contraindicated in patients with known hypersensitivity to L-Asparaginase or any component of its formulation. Always assess patient history prior to administration to avoid severe allergic reactions.
Q: Where should L-Asparaginase vials be stored before use?
A: Store L-Asparaginase vials in a cool, dry place, away from direct sunlight. Proper storage conditions ensure the stability and effectiveness of the medication until its two-year shelf life is reached.
Q: What quality certifications does this product hold?
A: L-Asparaginase Injection is manufactured in facilities certified for GMP, WHO-GMP, and ISO 9001:2015, affirming adherence to the highest standards of pharmaceutical manufacturing and quality assurance.
Q: What disposal protocols should be followed after administration?
A: Used vials, syringes, and residual product must be disposed of according to biohazard waste management protocols, ensuring environmental safety and reducing the risk of contamination.
Q: How can dealers, distributors, or hospitals in India obtain this product?
A: Dealers, distributors, exporters, manufacturers, suppliers, and wholesalers across India may procure L-Asparaginase Injection directly from certified pharmaceutical suppliers or authorized distribution channels, ensuring proper documentation and compliance with local regulations.