Contact Us

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.
Contact Us
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

Randolph, NJ

cGMP-Compliant
Packaging Campus

Why Leading Pharmaceutical Companies Choose MAK Pharma

From FDA compliance to scalable capacity — we deliver the reliability, expertise, and infrastructure that top pharmaceutical companies demand.

FDA Approved Packaging Facilities

Fully FDA-registered; meets all cGMP requirements.

17 Packaging Lines

2 Blister, 4 carton, bottle, and 1 steam tunnel lines.

Rapid Turnaround

Emergency fulfillment and accelerated timelines.

Regulatory Expertise

Deep FDA, DEA, and health canada experience.

One-Stop Contract Packaging

Procurement through delivery under one roof.

Experienced QA Team

Batch documentation, lot release.

Ready to Package Your Next Product?
Partner with an Experienced Pharmaceutical Packaging Company

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

Contact Us