Quality & Certifications

Internationally Recognized Standards

Our certifications reflect our unwavering commitment to pharmaceutical quality, safety, and regulatory compliance — recognized by global health authorities worldwide.

Global Accreditations

Our Quality Certifications

We maintain rigorous adherence to international Good Manufacturing Practices and food safety guidelines across all manufacturing facilities.

WHO-GMP
World Health Organization Good Manufacturing Practice
Certified
ISO 9001:2015
International Quality Management System
Certified
HALAL
Islamic Compliance Authority Certified
Certified
FSSAI
Food Safety & Standards Authority of India
Approved
EU GMP
European Union Good Manufacturing Practice
Compliant
US FDA
United States Food & Drug Administration
Compliant
PIC/S
Pharmaceutical Inspection Co-operation Scheme
Compliant
Global Reach

Global Presence & Target Markets

ANISKO HEALTHCARE is expanding its international presence, focusing on key healthcare markets across Asia, Africa, Middle East, and Latin America.

Global Export Network & Radar Hub
Global HQ (Ahmedabad, India)
Primary Focus Markets
Target Export Regions
🇮🇳 HQ: Ahmedabad, India ⭐ 🇲🇲 Myanmar & 🇰🇭 Cambodia 🇰🇪 Kenya, 🇺🇬 UG & 🇹🇿 TZ 🇳🇬 Nigeria & 🇬🇭 Ghana 🇵🇪 Peru, 🇪🇨 EC & 🇬🇹 GT
🌏
Southeast & South Asia
Primary Focus Markets
Myanmar Flag Myanmar Primary
Cambodia Flag Cambodia Primary
Maldives Flag Maldives
Vietnam Flag Vietnam
Malaysia Flag Malaysia
Sri Lanka Flag Sri Lanka
🌍
Africa Region
East & West Africa Markets
Kenya Flag Kenya
Nigeria Flag Nigeria
Uganda Flag Uganda
Ghana Flag Ghana
Tanzania Flag Tanzania
🌎
Latin America (LATAM)
High-Growth Emerging Markets
Peru Flag Peru
Ecuador Flag Ecuador
Guatemala Flag Guatemala
Quality Matrix

Understanding Our Quality Standards

Comprehensive regulatory dossiers (CTD, eCTD, ACTD) prepared for seamless health authority approvals globally.

WHO-GMP Guidelines
World Health Organization Standard

All active ingredients, excipients, and finished dosage forms undergo mandatory testing against USP, BP, and EP pharmacopoeia specifications prior to batch authorization.

In-Process Controls (IPC)
30-Minute Sampling Intervals

Weight variation, friability, hardness, disintegration, and dissolution profiling performed at strict 30-minute intervals throughout every production run.

Finished Product Assay
HPLC & UV Spectroscopy

High-performance liquid chromatography (HPLC) and quantitative UV analysis to confirm 100% active ingredient potency and purity.

Microbiological Limit Testing
Class 100 Laminar Flow Cleanrooms

Total aerobic microbial count, pathogen testing, and endotoxin monitoring conducted inside ISO-classified cleanroom environments.

QA Protocol

8-Step Quality Assurance Process

From raw material receipt to container sealing, quality assurance governs every single stage.

Pharma Quality Testing
01
Raw Material Testing
100% testing of active ingredients & excipients against USP/BP/EP specs.
02
In-Process Controls (IPC)
Weight variation, disintegration, hardness, and friability checks every 30 min.
03
Finished Product Assay
HPLC and UV spectrophotometric quantitative analysis of active content.
04
Microbiological Limit Testing
Sterility and pathogen testing in Class 100 laminar flow hoods.
05
Stability Chamber Testing
Accelerated & real-time stability testing under ICH climate zones.
06
Packaging & Sealing Inspection
Leak testing of Alu-Alu/Blister foils and tamper-evident seal verification.
07
CoA & Dossier Release
Certificate of Analysis signed by Qualified QA Head before batch release.
08
Pre-Shipment Inspection
Final box inspection, temperature loggers setup, and container sealing.

Require Regulatory Dossiers for Your Country?

Our regulatory compliance team provides CTD, eCTD, and ACTD dossiers formatted for your health authority.

Request Dossier & Quote View Products