One Plus Impex

Manufacturing Process

Committed to Quality, Compliance & Global Standards

At One Plus Impex, we follow a robust and regulated pharmaceutical manufacturing process, ensuring every batch of medicine meets international safety, efficacy, and quality standards. Our manufacturing is carried out at WHO-GMP certified and ISO-compliant partner facilities in India.

• APIs (Active Pharmaceutical Ingredients) and excipients are sourced from approved & audited vendors.

• All materials undergo quality testing as per pharmacopeial standards (USP/BP/EP/IP).

• Ingredients are accurately weighed in controlled environments using calibrated equipment.

• Materials are barcoded, labeled, and tracked for traceability.

• Based on dosage form (tablet, capsule, injection, etc.), raw materials are either:

  • Wet granulated

  • Dry mixed

  • Micronized

• Processed in GMP-compliant equipment under validated conditions.

• Tablets are compressed using automated rotary presses.

• Capsules are filled with precision dosing machines.

• Injectables are filled using aseptic filling lines inside sterile areas.

• Tablets are coated (if required) for protection or controlled release.

• Injectable vials are sterilized using autoclave / filtration processes.

• Final products are packed in blister packs, vials, strips, or ampoules as per market requirement.

• We offer custom and private label packaging for international clients.

• Each batch undergoes analytical testing in QC labs:

  • Assay

  • Dissolution

  • Microbial limit tests

  • Stability

• COA (Certificate of Analysis) issued with every shipment.

• Final products are released by the QA team after review of BMR/BPR.

• Export documentation (COA, MSDS, Invoice, Packing List) is prepared.

• Shipped in accordance with client country regulations & cold chain requirements.

• Tablets (uncoated, coated, chewable, sustained-release)

• Capsules (hard gelatin, softgel)

• Injections (liquid, lyophilized)

• Creams, Ointments, Gels

• Oral Syrups & Suspensions

• IV Fluids, Eye/Ear Drops