How Ifosfamide Mesna Injection is manufactured: a look inside our state-of-the-art facility
Ifosfamide mesna injection manufacturer in India: The demand for ifosfamide + mesna injection manufacturers in India is growing steadily due to rising cancer cases, expansion in oncology treatment infrastructure, and increased use of combination therapies in chemotherapy. This injection demand is strongly rising due to the increasing cancer incidence in India. India has seen a sharp rise in cancer cases, particularly testicular cancer, sarcomas, lymphomas, and solid tumors—conditions where ifosfamide is widely used as part of chemotherapy regimens. Even with this, mesna is co-administered with ifosfamide to prevent hemorrhagic cystitis, making the ifosfamide + mesna combination injection a critical formulation in oncology protocols.
Furthermore, the number of oncology centers and cancer treatment hospitals across India is expanding, especially in tier-2 and tier-3 cities, increasing demand for essential cancer drugs. In this, there is an important role for government health initiatives & insurance. These improve access to advanced cancer treatments, pushing demand for reliable manufacturers. Because of all this, many oncology brands and PCD companies prefer third-party manufacturers for ifosfamide + mesna to avoid the high costs of oncology-specific production setups. This allows them to get the DCGI-approved oncology manufacturing licenses in demand. They can also get the sterile injectable lines with WHO-GMP certification that allows them to export their products to South Asia, Africa, and CIS countries, where cancer drug access is limited. Hence, in this way, ifosfamide mesna injection manufacturing companies and their services are in huge demand.
What are the critical manufacturing steps in the leading ifosfamide-mesna injection manufacturer in india?
- Choosing high-quality raw materials: The process begins with the purchase of active pharmaceutical ingredients (APIS)—ifosfamide and mesna—from certified vendors or in-house api production facilities. Moreover, all raw materials are part of thorough quality testing following pharmaceutical standards (usp, EP, and IP).
- Sterile manufacturing environment: The production of injectable cancer medications necessitates rigorous aseptic conditions. Indian manufacturers follow:
- Class 100 clean rooms.
- ISO 14644-1 compliant areas
- Validated HVAC systems.
Hence, this all guarantees that the ready product is free of contaminants and suitable for intravenous administration.
- Formulations and compounding: Now our APIs are dissolved in modern compounding vessels with appropriate excipients. Also, the key process control factors involved with the ph, temperature, and solubility are continuously monitored.
- Aseptic filtration: before filling, the fluid is filtered through 0.22-micron sterilizing filters to remove any microbiological contamination.
- Fill and seal: The sterile fluid is transferred into the aseptic filling area. Moreover, these are filled into sterile vials using laminar airflow (LAF) devices and also sealed with pre-sterilized rubber stoppers and metal caps. Finally, each batch has its filled volumes and seal integrity checked. Hence, this allows us to be the top ifosfamide mesna injection manufacturer in India.
- Terminal sterilization or lyophilization (as required): Depending on formulation stability, for some batches we autoclave or freeze-dry (lyophilize) to extend shelf life and stability.
- In-process and final quality testing: Every batch of our injections always goes through comprehensive quality testing. These include sterility tests, uniformity of assay and substance, particulate matter inspection, and endotoxin levels (LAL tests). Hence, this ensures adherence to WHO-GMP, US FDA, and EU GMP criteria.
- Packaging & labeling: Once authorized, vials are tagged, packaged in tamper-evident boxes, and stored in cold chain facilities until distribution. Another important thing is that our packaging materials are also evaluated to ensure that they maintain product integrity.
- Regulatory documentation & batch release: As the top third-party ifosfamide with mesna injection manufacturer in India, we always ensure each batch is released only after thorough review by the quality assurance team. Also, batch manufacturing records (BMRS) and certificates of analysis (COAS) are provided with every shipment for traceability and compliance.
Ifosfamide + mesna injection: uses and benefits
The ifosfamide + mesna injection is a combination chemotherapy medication used primarily in oncology. It combines ifosfamide, a cytotoxic alkylating agent, with mesna, a neuroprotective agent, to treat certain types of cancer while minimizing side effects. This has many uses and benefits, like
- Treatment of testicular cancer, especially in metastatic or relapsed cases, is often used in combination with chemotherapy regimens.
- Soft tissue sarcomas & bone tumors: effective against a wide range of solid tumors, including osteosarcoma
- Lymphomas: used in both Hodgkin’s and non-Hodgkin’s lymphoma, usually in high-dose chemotherapy protocols
- Lung cancer, breast cancer, and cervical cancer (off-label or combination depending on the oncologist’s discretion and stage of cancer).
Ending time
To come to the end of this topic, we hope that you’ll understand that Spica Drugs is the leading brand of a reliable ifosfamide mesna injection manufacturer in India. Hence, don’t waste your time and call us now.
Contact Details
Ph: +91-8949055013 , 0172-5020013
Email: info@janusbiotech.in
FAQs
Q. What is ifosfamide mesna injection used for?
Ans. Ifosfamide mesna injection is used in cancer chemotherapy, primarily to treat testicular cancer, sarcomas, and other solid tumors. Mesna is used in conjunction with ifosfamide to reduce the urotoxic side effects.
Q. Are Spica Drugs’ ifosfamide mesna injection manufacturing facilities GMP-certified?
Ans. Yes, as the top ifosfamide mesna injection manufacturing company in India, our production facilities are WHO-GMP certified and comply with EU-GMP, US FDA, and other important international regulatory requirements.
Q. Does Spica Drugs offer contract manufacturing or private labeling?
Ans. Yes, we offer contract manufacturing, third-party labeling, and custom branding solutions to clients globally.