BIO APIs
Our Commitment to Quality
At Provis Biolabs, quality is our hallmark. We adhere to stringent international standards, including ISO and cGMP certifications, ensuring that every product meets the highest quality benchmarks.
Our Commitment to Quality
At Provis Biolabs, quality is our hallmark. We adhere to stringent international standards, including ISO and cGMP certifications, ensuring that every product meets the highest quality benchmarks.
Salient Features of our Bulk APIs
Antibiotic-free and solvent-free manufacturing process prioritizing safety and environmental sustainability.
Raw materials used are animal component free, TSE/BSE free certified and comply with IP/USP/EP.
Manufactured in WHO-GMP and GLP certified facility with ISO classified clean rooms following ICH Q7 principles to meet international standards.
Robust and state of the art manufacturing operations to supply large volumes of API bulk within short duration, meeting market demands efficiently.
Drug Master File (DMF) as per ICH M4 guideline.
GMP Quality Statement
- Personnel training records
- Manufactured and tested under GMP guidelines
- Batch-to-batch consistency
- Testing and traceability of raw material
- Documentation of QA, QC and Production
- Records of the maintenance and equipment calibration
- Stability monitors of product shelf life
- Antibiotic-free and solvent-free manufacturing process
- Animal origin free raw materials
- TSE/BSE free certified and comply with IP/USP/EP/BP
- Following ICH Q7 principles to meet international standards
- Drug Master File (DMF) as per ICH M4 guideline
Salient Features of our Bulk APIs
Quality Control Testing
Antibiotic-Free and Solvent-Free Manufacturing
Animal Component-Free Raw Materials
Orthogonal Quality Control Tests
Purity
Robust Manufacturing Operations
Compliance with Pharmacopeial Limits
Drug Master File (DMF)
Manufacturing in WHO-GMP and GLP Certified Facility
Our Accreditations
Explore Our BIOAPIs
Click on the links below to learn more about each of our BIOAPI products: