Compliance · Operational Infrastructure

A three-tier workflow architecture.

Zymetra's operational model is structured to serve high-volume institutional procurement with regulatory precision at every stage — no handoff introduces variance or documentation gaps.

Supplier QMS: ISO 13485:2016 AlignedMarkets: EU · India · MEA · SEA
compliance· zymetra ·

Regulatory Sync

Export documentation, CE/ISO/FDA alignment, customs support across destination markets.

Institutional Flow

Hospital tenders, logistics orchestration, and full batch tracking for procurement teams.

Strategic Sourcing

WHO-GMP partner audits, raw material vetting, and long-term supply agreements.

Supplier Certification Standards

Audited excellence.

The standards below are held by our manufacturing partners and govern the products we source and distribute. Zymetra's own statutory licenses are listed in the section that follows.

WHO-GMP Sourced

Manufacturing partners audited to WHO Good Manufacturing Practice standards.

ISO 13485:2016 Aligned

Products sourced from facilities operating ISO 13485:2016 quality management systems.

CE-Marked Supply

Devices distributed under manufacturer-held CE conformity for European market access.

CDSCO Licensed · FDA Aligned

Zymetra holds CDSCO Form 20B & 21B; documentation aligned with Indian and US regulatory frameworks.

Licenses & Registrations

Statutory documentation.

Our complete regulatory portfolio — drug licenses, foreign trade authorisation, and tax registration — verified and held on file. Originals available to qualified procurement partners on request.

Drug License — Form 20B thumbnail
Drug License — Form 20B
Wholesale License (Sale)

Authorisation under the Drugs and Cosmetics Act for wholesale sale and distribution of drugs other than those specified in Schedules C and C(1). Issued by the State Drugs Control Department.

Drug License — Form 21B thumbnail
Drug License — Form 21B
Wholesale License (Specified Drugs)

Authorisation for the wholesale distribution of specified drugs including biologicals and other regulated categories under Schedules C and C(1) of the Drugs and Cosmetics Rules.

Importer–Exporter Code (IEC) thumbnail
Importer–Exporter Code (IEC)
DGFT · Ministry of Commerce

Issued by the Directorate General of Foreign Trade, the IEC is the mandatory ten-digit identifier enabling Zymetra Medsystems to legally undertake import and export of medical devices and supplies across international borders.

GST Registration Certificate thumbnail
GST Registration Certificate
Goods & Services Tax — GoI

Statutory registration under the Central Goods and Services Tax Act, 2017. Confirms the company's compliance with India's unified indirect tax framework for institutional supply and inter-state distribution.

Manufacturing & Supply Chain

Sourcing Network

Vetted supplier partnerships with rigorous procurement standards, QA protocols, and compliance verification.

Vendor Partnerships

WHO-GMP aligned facility audits, collaborative quality management, and long-term agreements.

Export & Logistics

40ft container shipments, urgent air-freight, full cold-chain, and customs clearance support.

Geographic Coverage

India-wide institutional distribution, regional hubs, direct-to-hospital delivery, and international markets.

Growth Strategy

Future roadmap.

2025

Capacity & Diversification

Supply expansion by Q4 2025 and launch of specialized medical device categories.

2026

Geographic Expansion

Entry into African and Southeast Asian markets, plus Middle East institutional partnerships.

2027+

Global Leadership

R&D investment, sustainable manufacturing, and digital supply chain integration.