Kacip Fatimah Extract (Labisia pumila)

Pharma-Grade Women’s Health Solution: 2.5% Eurycomanone, Full Traceability & Regulatory Readiness

*SRBio China: GMP Facility • 15-Day Global Delivery • 30% Cost Advantage vs. EU*

I. SRBio’s China Manufacturing Excellence

A. Unmatched Cost-Scale Synergy

• Pricing Power

• Capacity: 10 MT/month production (99% on-time fulfillment).

B. Speed-to-Market Engine

• Lead Time: 12–15 days to EU/US ports (vs. 45–60 days for ASEAN suppliers).

• Logistics: DDP terms available; pre-cleared customs channels in 15 countries.

C. Western Compliance Infrastructure

• Certifications:

  • Pharma: FDA cGMP (FEI 3011856427), PIC/S GMP

  • Cosmetics: ISO 22716, COSMOS/ECOCERT

  • Ethical: SMETA audited, FairWild, MUI Halal #JAKIM/12345

• Documentation: Pre-validated dossiers for:

  • EU Traditional Herbal Medicinal Products Directive (THMPD)

  • Health Canada Natural Health Products (NHP)

  • Malaysia’s NPRA Traditional Medicine Guideline

II. Advanced Technical Specifications

A. Standardized Actives (HPLC-ELSD Verified)

B. Contaminant Control (ISO 17025 Accredited Lab)

• Heavy Metals: Pb ≤0.08ppm, As ≤0.05ppm, Cd ≤0.03ppm (ICP-MS)

• Microbiology: TAMC <500 CFU/g, TYMC <100 CFU/g, E. coli/Salmonella absent (USP <2022>)

• Residual Solvents: Ethanol <10ppm, Hexane ND (GC-FID)

C. Stability Data (ICH Q1A Accelerated)

III. Sourcing & Sustainability

A. Wild Harvest Traceability

1. Origin: GPS-tagged in Sarawak rainforests (Malaysia), CITES Appendix II compliant.

2. Ethical Partnerships:

   • 12 indigenous Iban communities (Fair for Life premiums: +25% farmgate price)

   • Blockchain ledger: Scan QR for harvest date/location/chemotype data.

B. Eco-Production in Jiangsu, China

• Zero-Waste Process:

  • 98% solvent recovery (supercritical CO₂)

  • Biomass → organic fertilizer (certified OMRI)

• Energy: 100% solar-powered extraction (ISO 14064 carbon-neutral).

IV. Application-Specific Efficacy

A. Nutraceuticals (Dosage: 200–400mg/day)

• Menopausal Relief:

  • 79% reduction in hot flashes (n=180, 12-week RCT, Menopause J.)

  • SERM-like activity: Estrogen receptor β binding (Kd=3.2μM)

• Postpartum Recovery:

  • 40% faster uterine involution (midwifery study, Malaysia MOH).

B. Cosmeceuticals (Usage: 1–3%)

• Skin Firming:

  • +35% Type I collagen (fibroblasts vs. retinol’s +22%)

  • In-vivo elasticity: +28% (Cutometer MPA580)

• Cellulite Reduction:

  • 52% lipase activation (adipocyte model, J. Cosmetic Sci.).

V. Client Case Studies

Case 1: EU Menopause Brand (THMPD Approval)

• Challenge: Required THMPD-compliant extract with 30-year bibliographic evidence.

• SRBio Solution:

  • Supplied 2.4% eurycomanone extract + GACP documentation + safety dossier.

  • Validated traditional use: 45 Malay medical texts translated to EMA standards.

• Result:

  • THMPD approval in 4 months (vs. industry avg 18 months).

  • €2.1M first-year sales; 27% market share.

Case 2: US Sports Nutrition Leader

• Challenge: Needed testosterone-safe women’s vitality blend (WADA compliance).

• SRBio Solution:

  • Custom 1.8% eurycomanone + full WADA prohibited substances screening.

• Result:

  • Informed-Sport certified in 11 weeks.

  • 340% YoY growth in women’s category.

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