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Omeprazole and Domperidone Capsules – Manufacturing in India

Third Party Pharma Manufacturing > Blog > pharma manufacturing > Omeprazole and Domperidone Capsules – Manufacturing in India
Omeprazole and Domperidone Capsules

Omeprazole and Domperidone Capsules – What Brands Should Know Before Manufacturing

When someone searches omeprazole and domperidone capsules, they usually already understand the market demand.

This combination is widely prescribed.
It has stable demand across retail and hospital segments.
And many pharma brands include it in their core portfolio.

But manufacturing this product consistently is not as simple as putting two APIs together.

It requires controlled production, careful formulation, and strong quality discipline.

Why This Combination Requires Careful Manufacturing

Omeprazole is acid-labile.
It needs protection from stomach acid.

That’s why it is often produced as enteric-coated pellets inside capsules.

Domperidone has its own stability considerations.

When combined, manufacturing must ensure:

  • Proper dosage accuracy

  • Stability under storage

  • Uniform pellet coating

  • Controlled release where required

If pellet coating thickness varies, the drug release profile changes.
If moisture control is weak, stability can drop.

This is where manufacturing discipline matters.

How Omeprazole and Domperidone Capsules Are Manufactured

Let’s look at it practically.

The process usually involves:

  1. Pellet formation or procurement

  2. Enteric coating of omeprazole pellets

  3. Blending with domperidone (where applicable)

  4. Capsule filling under controlled conditions

  5. Packaging in moisture-protective materials

Each step requires strict parameter control.

Moisture, temperature, and handling must be carefully monitored.

Capsule shell quality also matters for long-term stability.

Raw Material Discipline Is Critical

Both APIs must be sourced from approved vendors.

Serious manufacturers:

  • Test incoming raw materials

  • Verify purity and potency

  • Maintain batch traceability

  • Store materials under controlled conditions

Even slight variation in API quality affects finished product performance.

This is why raw material discipline defines manufacturing reliability.

Quality Control in Capsule Production

Quality control does not begin at the end.

It runs throughout production.

For omeprazole and domperidone capsules, QC typically includes:

  • Assay testing

  • Dissolution testing

  • Uniformity of weight

  • Stability monitoring

  • Moisture content evaluation

If dissolution profiles are inconsistent, prescription confidence drops quickly.

Brands that ignore this stage risk long-term market damage.

Compliance – Especially Important for High-Prescription Products

Since this combination is widely prescribed, compliance becomes even more critical.

Manufacturers must maintain:

  • Valid drug manufacturing licenses

  • GMP-compliant facilities

  • Batch documentation

  • Regulatory-ready records

High-demand products attract higher scrutiny.

Compliance protects against disruption.

Scalability – Where Manufacturing Strength Shows

Omeprazole and domperidone capsules often become high-volume SKUs.

If a manufacturer cannot scale smoothly:

  • Delivery timelines suffer

  • Quality variation increases

  • Market supply becomes unstable

Scalable manufacturing requires:

  • Adequate machinery capacity

  • Secured raw material supply

  • Structured QC support

  • Realistic production scheduling

Scaling without planning creates instability.

Why Many Brands Choose Third-Party Manufacturing for This Product

Setting up capsule manufacturing lines with enteric coating capability requires:

  • Investment in equipment

  • Skilled technical staff

  • Quality infrastructure

  • Regulatory approvals

For many brands, third-party manufacturing is more practical.

It allows focus on:

  • Distribution

  • Doctor engagement

  • Market expansion

But success depends entirely on the strength of the manufacturing partner.

Where Impelled Remedies Supports Capsule Manufacturing

Impelled Remedies operates from Ambala, Haryana, offering structured third-party and contract manufacturing.

For products like omeprazole and domperidone capsules, the emphasis remains on:

  • Controlled process parameters

  • Strong quality testing

  • Compliance-first operations

  • Scalable production planning

For brands building a gastro portfolio, stable capsule production is essential.

What To Evaluate Before Finalising a Manufacturer

Before choosing a partner, ask:

  • How is pellet coating controlled?

  • How is dissolution consistency maintained?

  • Are stability studies conducted properly?

  • Can production increase if demand rises?

  • Are compliance documents updated and clear?

These answers protect your product’s long-term performance.

FAQs

Is omeprazole and domperidone capsule manufacturing complex?
Yes, due to stability and coating requirements.

Can third-party manufacturers handle this combination safely?
Yes, if infrastructure and QC systems are strong.

Does scaling increase risk for capsule products?
Yes, if process control and moisture management are weak.

Is compliance mandatory for this combination?
Yes, as with all prescription pharma products.

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