Radhey Bio-Tech – API Manufacturer in India
About Radhey Bio-Tech
Radhey Bio-Tech Pvt. Ltd. is an Indian pharmaceutical manufacturing company focused on the development and production of Active Pharmaceutical Ingredients (APIs).
The company operates a CDSCO-licensed manufacturing facility aligned with Indian GMP requirements under Schedule M, supported by structured quality systems and in-house Quality Control. Radhey Bio-Tech also provides CMO services, process execution & commercial manufacturing support (technology transfer for customer provided processes), and toll manufacturing, supporting partners from development through commercial API supply.
In addition, the company facilitates the supply of generic finished formulations through approved third-party manufacturing partners, offering a reliable sourcing option alongside API manufacturing.
Radhey Bio-Tech is committed to process discipline, compliance, and long-term partnerships with pharmaceutical companies across domestic and international markets.
API Product Portfolio
Active Pharmaceutical Ingredients manufactured at our facility in Udaipur, Rajasthan, supported by complete quality and regulatory documentation.
Solutions
We provide pharmaceutical manufacturing and development support services focused on Active Pharmaceutical Ingredients (APIs). Our capabilities are designed to support process development, process execution & manufacturing support (technology transfer for customer provided processes), and commercial API manufacturing under controlled and compliant systems.
Comprehensive API Solutions
We provide integrated pharmaceutical manufacturing support focused on Active Pharmaceutical Ingredients. Our capabilities span process development, process scale-up and optimization, process execution, technology transfer for customer-provided processes, validation support, commercial manufacturing, CMO and toll manufacturing, and long-term supply programs.
Our approach combines manufacturing excellence, quality-driven operations, technical expertise, and responsive commercial support to deliver reliable solutions aligned with customer requirements.
Manufacturing Excellence
Radhey Bio-Tech operates a CDSCO-licensed API manufacturing facility aligned with Indian GMP requirements under Schedule M. Our manufacturing infrastructure is designed to support multi-step chemical synthesis, controlled processing, commercial-scale production, and consistent batch execution.
Manufacturing Capabilities
- Multi-step chemical synthesis
- Pilot-scale to commercial production
- Process scale-up and optimization
- Flexible production scheduling
- Dedicated manufacturing infrastructure
- Commercial supply programs
- Process validation support
- Batch-to-batch process consistency
- Process monitoring and in-process controls
- Manufacturing traceability
- Capacity planning and flexibility
- Supply continuity
- Customer-specific manufacturing planning
- Long-term manufacturing programs
Research & Development
Our R&D function supports process optimization, scale-up, process understanding, manufacturing execution, and development of robust and reproducible processes for commercial API production.
Through close coordination between R&D, manufacturing, and quality functions, we support process scale-up, validation activities, manufacturing readiness, and consistent commercial execution.
Quality & Analytical Excellence
Quality is embedded throughout our manufacturing operations. Our quality framework is supported by Quality Assurance (QA), Quality Control (QC), In-Process Quality Control (IPQC), batch traceability, structured documentation controls, and advanced analytical capabilities.
Our analytical laboratory supports:
- HPLC Analysis
- Gas Chromatography (GC)
- FTIR Spectroscopy
- UV-Visible Spectrophotometry
- Microbiological Analysis
- Stability Studies
Our systems emphasize GMP-compliant operations, ICH Q7-aligned quality systems, batch-to-batch consistency, customer audit support, continuous quality improvement, and regulatory compliance.
Finished Formulations – Generic Medicines
In addition to API manufacturing, Radhey Bio-Tech facilitates the supply of finished pharmaceutical formulations (generic medicines) through approved third-party manufacturing partners.
Third-Party Manufacturing
These formulations are manufactured at independent, compliant facilities operated by established formulation manufacturers, while Radhey Bio-Tech supports commercial coordination, product selection, and supply facilitation based on customer requirements.
Tablet Dosage Forms
The finished dosage forms offered include tablet formulations, supplied for domestic and international markets as per mutually agreed commercial and regulatory scope.
Quality Assurance
Radhey Bio-Tech does not directly manufacture finished formulations but works with experienced partner manufacturers to provide customers with a reliable sourcing option alongside API supply.
Partner with Radhey Bio-Tech
Built on Manufacturing Excellence. Driven by Quality. Focused on Long-Term Partnerships.
From technical consultation and process scale-up to validation support, CMO and toll manufacturing, commercial supply coordination, and long-term manufacturing programs, Radhey Bio-Tech is positioned to support pharmaceutical partners with dependable manufacturing solutions.
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Schedule M
Aligned
Manufacturer