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Quality You Can Count On

We maintain strict quality standards at every steps – from component selection to final packaging – ensuring safe, compliant and consistent product for ore customers.
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FDA Compliance
cGMP Standards
Quality Assurance
In-Process Checks
Validated Processes
Traceability
Regulatory Compliance
Supplier Quality
Final Product Inspection
FDA Compliance
cGMP Standards
Quality Assurance
In-Process Checks
Validated Processes
Traceability
Regulatory Compliance
Supplier Quality
Final Product Inspection
FDA Compliance
cGMP Standards
Quality Assurance
In-Process Checks
Validated Processes
Traceability
Regulatory Compliance
Supplier Quality
Final Product Inspection

Built Around Quality

MAK Pharma USA is proud to be FDA-audited and holds key certifications and regulatory approvals from leading global authorities. these certifications ensure that our products meet the highest standards of quality, safety and efficacy.

Product Safety

Protecting patients and consumers.

Compliance

Meeting global requirements.

Quality Assurance

Continuous monitoring and improvement.

Trust & Transparency

Building long-term partnerships.

Quality Checks

Quality Checks Built into Every Process

MAK Pharma’s high-quality packaging services make you get the best packaging for all your pharmaceutical, nutraceutical, and veterinary products. MAK Pharma believes in the strategy of error tolerance i.e. detection and correction rather than error avoidance, which
includes:
  • Strict component release criteria
  • In-process component check
  • validated vendor/component providers
  • CoC for bottles
  • Validated cleaning procedure,
  • Allergen program
  • Equipment IQ, OQ, PQ
  • Mock recalls
  • Internal core audits
  • Under Strict 21CFR 210 & 211 Guidelines
  • Components traceability
  • Change control
  • CAPA
  • GMP training
  • Follow AQL
  • Retain sample
  • Vendor audit
Quality Checks Built

Certifications & Accreditations

Our multi-certification portfolio demonstrates unwavering commitment to quality, safety, and regulatory excellence.
health canada
k
gmp registered
gmp supplements
gmp drugs
u service
FDA Approved
ul certified
ssci
organic
sedex
grma pharma
certified msc

Randolph, NJ

cGMP-Compliant
Packaging Campus

Why Leading Pharmaceutical Companies Choose MAK Pharma

Delivering reliable pharmaceutical packaging solutions through FDA-registered operations, advanced infrastructure, and a commitment to quality.

FDA-Registered Packaging Facility

FDA-registered for pharmaceutical labeling, packaging, relabeling, and repackaging operations.

17 Packaging Lines

Dedicated packaging lines supporting bottles, blisters, cartoning, and specialized packaging requirements.

Flexible Turnaround

Responsive scheduling and flexible production capabilities to meet customer timelines.

Regulatory Expertise

Experience supporting FDA, DEA, and applicable cGMP regulatory requirements.

One-Stop Contract Packaging

Integrated pharmaceutical packaging solutions from project planning through final shipment.

Dedicated Quality Team

Quality oversight, batch documentation, and controlled product release processes.

Let's Package Your Next Product Together.

Partner with MAK Pharma for reliable pharmaceutical packaging solutions tailored to your needs.

Contact our team to discuss your project requirements. we’ll respond with a full capabilities overview and competitive proposal.

Request a Quote