Swapnroop Drugs & Pharmaceuticals is a pharmaceutical and biopharmaceutical API manufacturer and supplier of Tocilizumab in India, supporting pharmaceutical companies, biotechnology organizations and formulation manufacturers with biologic drug-substance requirements.
Tocilizumab is a recombinant humanized IgG1 monoclonal antibody directed against the human interleukin-6 (IL-6) receptor. It binds to both soluble and membrane-bound IL-6 receptors and inhibits IL-6-mediated signaling. Tocilizumab is produced using recombinant DNA technology in Chinese hamster ovary (CHO) cells.
Tocilizumab is identified by CAS Number 375823-41-9. FDA and NIH sources describe it as a humanized anti-human IL-6 receptor monoclonal antibody with an approximate molecular mass in the 148–149 kDa range, including glycosylation.
Tocilizumab belongs to the interleukin-6 receptor antagonist and monoclonal antibody categories. It consists of two heavy chains and two kappa light chains connected by disulfide bonds and contains an N-linked glycosylation site on each heavy chain.
The API is used in biological medicinal products for inflammatory and immune-mediated conditions. Current European medicinal products containing tocilizumab include both originator and biosimilar products. EMA lists tocilizumab products for indications including rheumatoid arthritis, juvenile idiopathic arthritis, cytokine-related conditions and COVID-19 in specified clinical circumstances.
| Parameter | Details |
|---|---|
| Product Name | Tocilizumab |
| CAS Number | 375823-41-9 |
| UNII | I031V2H011 |
| Development/Reference Code | RO4877533 / MRA |
| Molecular Formula | C₆₄₂₈H₉₉₇₆N₁₇₂₀O₂₀₁₈S₄₂* |
| Molecular Weight | Approximately 148–149 kDa |
| Molecule Type | Recombinant Humanized IgG1 Monoclonal Antibody |
| Light Chain | Kappa |
| Production System | CHO cells |
| Target | Human Interleukin-6 Receptor (IL-6R) |
| Therapeutic Category | Immunosuppressant / Immunomodulator |
| ATC Code | L04AC07 |
*The molecular formula is an estimated/theoretical representation and can vary according to glycosylation and other post-translational modifications; FDA/NCATS identify the molecular weight of tocilizumab at approximately 145–149 kDa depending on the representation and molecular form.
Tocilizumab binds to both soluble IL-6 receptor (sIL-6R) and membrane-bound IL-6 receptor (mIL-6R). This blocks IL-6-mediated signaling and reduces downstream inflammatory responses.
Tocilizumab is used as the active biological substance in medicinal products for several inflammatory and immune-mediated conditions, including:
The exact approved indications vary according to the specific tocilizumab product and jurisdiction. Current EMA records include multiple authorized tocilizumab products and biosimilars.
Swapnroop Drugs & Pharmaceuticals supports pharmaceutical and biopharmaceutical customers seeking Tocilizumab API / biologic drug substance for qualified development, manufacturing and supply requirements.
As a Tocilizumab API supplier in India, Swapnroop can support requirements involving recombinant monoclonal antibody drug substances, subject to applicable manufacturing, quality, regulatory and customer-specific requirements.
Tocilizumab can be supplied for qualified biopharmaceutical requirements including:
For biologic drug substances, quantity, formulation, concentration, storage conditions and release criteria are generally established according to the specific manufacturing process and regulatory dossier.
Tocilizumab is a complex recombinant monoclonal antibody rather than a conventional small-molecule API. Therefore, quality assessment is based on biological and physicochemical characterization, including identity, purity, aggregation, charge variants, glycosylation, protein concentration, potency and other product-specific critical quality attributes.
Regulatory assessments for tocilizumab biosimilars describe control of the active substance through identity, purity, biological activity and physicochemical characterization rather than conventional small-molecule tests such as melting point or residue on ignition.
Tocilizumab drug substance storage conditions are product- and manufacturing-process-specific and should follow the approved stability program and applicable product specification.
Finished tocilizumab medicinal products are commonly supplied as sterile solutions. For example, the EU RoActemra formulation is supplied as a 20 mg/mL concentrate, with 80 mg/4 mL, 200 mg/10 mL and 400 mg/20 mL presentations. The concentrate is a clear to opalescent, colorless to pale-yellow solution with a pH of 6.3–6.7.
These finished-product parameters should not be treated as bulk drug-substance specifications.
Documentation for Tocilizumab API/biologic drug substance can be provided according to the applicable project and regulatory requirements and may include:
Tocilizumab is an established recombinant humanized anti-IL-6 receptor IgG1 monoclonal antibody with extensive pharmaceutical and biopharmaceutical applications. Swapnroop Drugs & Pharmaceuticals supports organizations seeking Tocilizumab API in India for qualified development, bulk procurement and biopharmaceutical manufacturing requirements.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |