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Global API Sourcing & Regulatory Compliance

Brimchem is a South African company specializing in sourcing cost-effective Active Pharmaceutical Ingredients (APIs) from China, ensuring full regulatory compliance and cGMP standards for global markets.

We deliver exceptional service with efficiency, professionalism, and documentation that meets international regulatory requirements.

Pharmaceutical Manufacturing

About Brimchem

A trusted partner in the global pharmaceutical supply chain, connecting high-quality Chinese API manufacturers with international markets.

Laboratory Research

Our Mission

Brimchem focuses on sourcing cost-effective Active Pharmaceutical Ingredients (APIs) from China and facilitating their regulatory approval across global markets. We pride ourselves on delivering outstanding service with efficiency, effectiveness, and professionalism.

We work closely with our Chinese manufacturing partners to ensure all documentation provided to terminal customers or regulatory authorities meets the highest international standards.

Our support extends to helping manufacturers achieve and maintain cGMP compliance aligned with recognized global benchmarks, ensuring quality and safety at every step.

Our Services

From sourcing to compliance, we provide end-to-end support for pharmaceutical APIs entering global markets.

Global API Sourcing

We identify and source high-quality, cost-effective Active Pharmaceutical Ingredients from trusted manufacturers in China, tailored to your formulation and market needs.

Regulatory & Technical Support

Full documentation packages including CEP, ASMF, DMF, and EDCTD submissions. We ensure compliance with EU, FDA, TGA, Health Canada, and other global regulatory bodies.

cGMP Compliance Assistance

We guide Chinese manufacturers through cGMP implementation and audits, ensuring alignment with international standards such as PIC/S, WHO, and EU GMP.

Our Products

A selection of high-purity Active Pharmaceutical Ingredients sourced and supported by Brimchem for global regulatory submission.

💊

Paracetamol API

High-purity paracetamol for oral formulations. Complies with BP, USP, and Ph. Eur. standards.

  • Purity: ≥99.5%
  • Appearance: White crystalline powder
  • Packaging: 25kg fiber drums
💊

Ibuprofen API

Pharmaceutical-grade ibuprofen for solid and liquid dosage forms. cGMP certified.

  • Purity: ≥99.0%
  • Form: Fine white powder
  • Regulatory: DMF available
💊

Metformin HCl

First-line antidiabetic agent. High solubility and stability. Suitable for tablet manufacturing.

  • Purity: ≥99.5%
  • Appearance: White crystalline powder
  • Compliance: USP, BP, EP
💊

Atorvastatin Calcium

Potent statin for lipid-lowering therapy. High batch consistency and low impurity profile.

  • Purity: ≥99.0%
  • Form: Off-white powder
  • Regulatory: CEP in progress
💊

Amoxicillin Trihydrate

Broad-spectrum antibiotic. Ideal for capsule and suspension formulations.

  • Purity: ≥95.0%
  • Appearance: White to yellowish powder
  • Compliance: USP, BP
💊

Lisinopril

ACE inhibitor for hypertension and heart failure. Stable and highly bioavailable.

  • Purity: ≥98.5%
  • Form: White powder
  • Regulatory: ASMF support available
💊

Omeprazole

Proton pump inhibitor for gastric acid reduction. High purity and stability.

  • Purity: ≥99.0%
  • Appearance: White to off-white powder
  • Compliance: USP, EP
💊

Ciprofloxacin HCl

Fluoroquinolone antibiotic with broad microbial coverage. Suitable for oral and IV use.

  • Purity: ≥98.5%
  • Form: Crystalline powder
  • Regulatory: Full DMF documentation
💊

Levothyroxine Sodium

Thyroid hormone replacement. High potency and batch-to-batch consistency.

  • Purity: ≥98.0%
  • Appearance: White powder
  • Compliance: USP, Ph. Eur.
💊

Sertraline HCl

SSRI antidepressant with proven efficacy. Ideal for tablet and capsule production.

  • Purity: ≥99.0%
  • Form: Fine white powder
  • Regulatory: cGMP compliant

Why Choose Brimchem?

  • Global Reach: Serving customers in Europe, South Africa, Brazil, Australia, New Zealand, and Ireland.
  • Regulatory Expertise: Full support for CEP, ASMF, DMF, and EDCTD submissions.
  • cGMP Compliance: We assist manufacturers in achieving and maintaining international cGMP standards.
  • Documentation Excellence: All technical and regulatory documents meet the highest international standards.

By the Numbers

100+
APIs Sourced
15+
Global Markets
10
Manufacturing Partners
12
Years of Excellence

Frequently Asked Questions

What regions does Brimchem serve?

We have multinational customers in Europe, Ireland, South Africa, Brazil, Australia, and New Zealand.

Do you provide regulatory documentation?

Yes, we supply full regulatory dossiers including CEP, ASMF, DMF, and EDCTD-compliant documentation.

How do you ensure cGMP compliance?

We work directly with Chinese manufacturers to implement and maintain cGMP standards in line with PIC/S, WHO, and EU GMP requirements.

Can you source custom APIs?

Yes, we specialize in sourcing specific APIs based on customer requirements and market needs.

Is technical support available?

Absolutely. Our team provides end-to-end technical and regulatory support throughout the product lifecycle.

Get in Touch

For inquiries about our APIs, regulatory support, or partnerships, please visit our official website.

Visit Official Website

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