Capabilities & Compliance
Built for quality. Documented for compliance. Ready for global markets.
Divyaman Biotech maintains a comprehensive regulatory and quality framework spanning Indian domestic requirements and US export compliance. Every certification, registration, and process is current, documented, and available for partner review.
Regulatory Certifications
Active, current, audit-ready.
FSSAI Central License
License No: 10725998001296
- Authority
- Food Safety and Standards Authority of India
- Scope
- Marketing and distribution of nutraceutical products across all Indian states
- Significance
- Central license (vs state license) enables pan-India operations and is required for interstate commerce and e-commerce sales.
US FDA Facility Registration
Registration No: 15746453854 · DUNS No: 771700228
- US Agent
- OmniGrowth Solutions LLC, 254 Chapman Road, Ste 208 #20357, Newark, DE 19702, USA
- Valid Until
- December 31, 2026
- Significance
- Mandatory registration under the Federal Food, Drug and Cosmetic Act (as amended by the Bioterrorism Act of 2002 and FSMA) for any facility manufacturing, processing, packing, or holding food/supplements for US consumption. This registration enables Divyaman Biotech to legally export and sell dietary supplements in the United States market.
FDA facility registration is a compliance requirement and does not constitute FDA approval or endorsement of any specific product. The US FDA does not approve dietary supplements.
GMP Certified Manufacturing
Standard: Current Good Manufacturing Practices (cGMP)
- Scope
- All contract manufacturing partners are selected on the basis of active GMP certification, ensuring standardised production processes, quality control protocols, and documentation across every production batch.
Manufacturing Model
Strategic CMO partnerships. India’s best infrastructure.
Divyaman Biotech operates an asset-light manufacturing model, partnering with carefully selected Contract Manufacturing Organisations (CMOs) across India. This approach allows us to access world-class manufacturing facilities, GMP-certified production lines, and pharmaceutical-grade quality systems without the capital constraints of owning manufacturing infrastructure.
Our CMO selection criteria include: active GMP certification with documented audit trail, established track record in nutraceutical/pharmaceutical production, capacity for domestic and export-scale production, willingness to accommodate third-party batch testing, and complete batch documentation and traceability.
Current manufacturing is conducted at GMP-certified facilities in Indore, Madhya Pradesh, with capabilities spanning capsule filling, blister packing, bottle filling, and quality-controlled raw material handling.
Quality Assurance
Every batch. Every time. No exceptions.
01
Formulation
Evidence-based ingredient selection with clinically meaningful dosing. No proprietary blends, no token ingredients.
02
Raw Material Sourcing
Ingredients sourced from qualified, documented suppliers. Identity and potency verified before production.
03
Manufacturing
Produced in GMP-certified facilities under strict SOPs. In-process quality checks at every stage.
04
Third-Party Lab Testing
Every production batch independently tested by NABL-accredited laboratories. Testing covers active ingredient potency, heavy metals (Lead, Arsenic, Cadmium, Mercury), microbiological parameters, and physical specifications.
05
COA Publication
Full Certificate of Analysis published on brand websites and accessible via QR code on product packaging. Complete transparency for consumers and partners.
06
Release
Product released for sale only after all quality parameters are confirmed within specification.
Testing Parameters
- Potency
- Active ingredient identity and content vs label claim
- Heavy Metals
- Lead (<3ppm), Arsenic (<1.1ppm), Cadmium (<1.5ppm), Mercury (<0.1ppm)
- Microbiological
- Total Plate Count, Yeast & Mould, E. coli, Salmonella, S. aureus, Coliforms
- Physical
- Capsule weight uniformity, moisture content, appearance
Documentation
Available to qualified partners on request.
- FSSAI Central License (copy)
- US FDA Facility Registration Certificate
- GMP Certificates from manufacturing partners
- Product-specific Certificates of Analysis (batch-level)
- Product specifications and formulation summaries
- US-compliant labelling drafts (for export partners)
- Company registration documents (CIN, PAN, GST)