GMP Certified Calamine Manufacturer – Pharma-Grade Compliance and Global Reach

Kapil Radadiya
Written by Kapil Radadiya
GMP Certified Calamine Manufacturer – Pharma-Grade Compliance and Global Reach

In today’s pharmaceutical and personal care landscape, quality and compliance are non-negotiable. When sourcing raw materials like calamine powder, businesses around the globe seek trusted partners who can meet strict manufacturing and regulatory standards.

That’s where Chemignition Laboratory stands out—as a leading GMP Certified Calamine Manufacturer, delivering pharma-grade calamine powder to clients worldwide.

This blog explores the importance of GMP certification, calamine’s diverse applications, Chemignition’s quality assurance protocols, and why global pharma and cosmetic companies trust Chemignition for bulk supply.

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What is Calamine Powder?

Calamine is a zinc-based inorganic compound formed from zinc oxide (ZnO) and a trace amount of iron oxide (Fe₂O₃), giving it its pale pink hue. Its soothing, cooling, astringent, and anti-itching properties make it ideal for skin care and pharmaceutical formulations.

Why GMP Certification Matters for Calamine Manufacturing

GMP (Good Manufacturing Practices) is an internationally recognized system that ensures products are consistently produced and controlled according to quality standards. In the context of calamine powder:

  • It ensures batch-to-batch consistency
  • Protects against contamination and adulteration
  • Provides traceability for every lot manufactured
  • Demonstrates compliance with international pharmacopeias (IP/BP/USP)
  • Ensures regulatory readiness for global export markets

For pharmaceutical and personal care companies, sourcing from a GMP-certified calamine manufacturer significantly reduces risk and enhances product safety.

Chemignition Laboratory – Leading GMP Certified Calamine Manufacturer

Located in India, Chemignition Laboratory is a premier manufacturer and global exporter of zinc-based calamine powder. The company operates under GMP and ISO 9001:2015 certified facilities, catering to the pharmaceutical, cosmetic, veterinary, and personal care industries.

With a decade of experience in formulation-grade mineral ingredients, Chemignition supports top-tier companies with:

  • Regulatory-grade production
  • Full documentation support
  • Custom packaging
  • Worldwide delivery

Manufacturing Capabilities at Chemignition

ParameterDetail
Facility CertificationsGMP, ISO 9001:2015
Production Capacity100 MT/month
Quality ControlIn-house QA/QC laboratory with microbiology testing
Compliance StandardsIP, BP, USP
Custom Particle SizeMicronized and non-micronized calamine available
Documentation SupportCOA, MSDS, TDS, Certificate of Origin, Packing List

Product Grades and Specifications

Chemignition offers calamine powder in the following grades:

  • Pharmaceutical Grade (IP/BP/USP)
  • Cosmetic Grade
  • Industrial Grade (for chemical processes)
SpecificationResult
AppearancePink fine powder
Assay (ZnO)98.5%–100.5%
Iron Oxide (Fe₂O₃)0.4% – 1.0%
Loss on Drying< 1.0%
pH (5% solution)6.5 – 8.0
SolubilityInsoluble in water
Particle SizeCustom (10–100 microns)
Heavy MetalsComplies with pharmacopeia

Documentation & Export Compliance

As a GMP certified calamine manufacturer, Chemignition provides a complete set of export and regulatory documents, including:

  • Certificate of Analysis (COA)
  • Technical Data Sheet (TDS)
  • Material Safety Data Sheet (MSDS)
  • Certificate of Origin
  • Packing List & Commercial Invoice
  • Barcoding & labeling (upon request)
  • GMP & ISO Certifications

Packaging and Global Delivery

Chemignition ships calamine powder globally in customized, tamper-proof packaging, ensuring safe transit across various climates and routes.

Packaging TypeSizeApplication
HDPE Drums25–50 kgPharma and export use
Fiber Drums25 kgCosmetic and lab use
Jumbo Bags500–1000 kgIndustrial bulk supply
Vacuum Sealed Bags1–5 kgR&D or trial formulations

The company supports:

  • Air and sea freight
  • Customs clearance assistance
  • Real-time tracking for shipments
  • Flexible minimum order quantities

Global Export Markets

Chemignition’s GMP-certified calamine powder is exported to:

  • United States
  • Germany & EU Nations
  • UAE & Saudi Arabia
  • Vietnam & Thailand
  • South Africa & Kenya
  • Bangladesh & Sri Lanka

Industries Served

IndustryUse Case
PharmaceuticalCalamine lotion, anti-itch creams, medicated powders
CosmeticsOil-control creams, BB creams, face masks
VeterinarySkin care ointments for pets and livestock
Personal CareSunscreens, baby powder, anti-chafing products
OEM/White LabelRaw material supply for branded formulations

Why Choose Chemignition Laboratory?

FeatureBenefit
GMP Certified ProductionPharma-grade safety and international credibility
High Purity Zinc-Based PowderSafe, skin-friendly and stable
Global Delivery NetworkSupports air/sea freight, real-time tracking
Custom Packaging & OEM SupportReady for white-label and B2B packaging needs
Responsive Team & DocumentationQuick turnaround for samples, quotes, and documents

How to Get Started

Interested in sourcing calamine from a trusted GMP certified manufacturer?

🌐 Website: www.chemignition.com

You can request:

  • Free technical samples
  • Specification sheets
  • Commercial pricing
  • Packaging options for your product line

FAQs

What does it mean to be a GMP Certified Calamine Manufacturer?

It means the manufacturer follows Good Manufacturing Practices ensuring calamine powder is produced under strict hygiene, quality control, and traceability standards—suitable for pharmaceutical, cosmetic, and regulatory use.

Is GMP-certified calamine suitable for human skin?

Yes. GMP-certified calamine is manufactured with pharmaceutical-grade purity, making it safe for use in topical medications, skincare products, and baby care formulations.

What is the typical assay value of GMP-grade calamine powder?

The assay (Zinc Oxide) typically ranges between 98.5% and 100.5%, depending on batch quality and pharmacopeia compliance (IP/BP/USP).

Do you supply calamine with supporting documentation?

Absolutely. Chemignition provides COA, MSDS, TDS, Certificate of Origin, and GMP/ISO compliance documents with every shipment.

Can Chemignition export GMP calamine globally?

Yes. We export to over 50 countries, including the USA, Germany, UAE, Vietnam, and South Africa, with full customs documentation and compliant packaging.