Global B2B Pharmaceutical Sourcing · Dossier Licensing · Named-Patient Access
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Pharmaceutical Contract Packaging

Primary and secondary packing, relabelling and serialisation for your medicines, through GMP-licensed packaging sites in India.

Packaging is a regulated manufacturing step

In most countries, including India, putting a medicine into its primary pack is part of manufacturing and needs a licence and GMP. So does relabelling. A contract packer is therefore chosen much like a manufacturer: by its licence, its approvals and its documentation.

The other half is market rules: the pack material that gives the stability your climate needs, the language and layout of the label and leaflet, and the serialisation or barcodes the importing and exporting countries require.

We find packaging sites that match your product and market, either as part of a manufacturing project or for packing bulk you already buy.

Tell us this to get a quote

  • Product, dosage form and whether you supply the bulk
  • Primary pack: blister type, strip, bottle, sachet, tube
  • Secondary pack: carton, leaflet, languages
  • Serialisation or barcode requirements of your market
  • Target market(s)
  • Annual volume and pack sizes

What to check in a contract packer

Licence and approvals

The site needs a manufacturing licence that covers packing of your dosage form, and approvals that your market accepts for the packing site, which is often listed in the dossier.

Pack materials

PVC, PVC/PVdC, Alu-Alu cold-form blisters, strips, HDPE or glass bottles. The material should match your stability data; a change usually needs a regulatory variation.

Serialisation and barcodes

India's export rules require barcodes on export packs. The EU Falsified Medicines Directive requires a unique identifier and tamper-evident seal on prescription medicines, and the US requires serialised product identifiers under the DSCSA. Ask which systems the line runs.

Artwork and languages

Multi-language leaflets and cartons, Braille where required, and artwork control so the right version reaches the right batch.

Segregation

Beta-lactams, hormones and cytotoxic products need dedicated or segregated packing areas, just as in manufacturing.

Line clearance and records

Mix-ups between products or label versions are the classic packaging failure. Ask how line clearance and reconciliation of printed materials are documented.

Choosing the blister material

MaterialMoisture protectionTypical use
PVCLowProducts that are not sensitive to moisture
PVC/PVdCMedium to high, depending on coating weightMost tablets and capsules for hot, humid markets
Alu-Alu (cold-form)Very high; also blocks lightMoisture- or light-sensitive products, effervescent and some softgels
Alu stripVery highCommon in India and some export markets; effervescent and hygroscopic products

The pack must be the one the stability study was done in. Changing it later is a variation in most markets.

How it works with PharmaTradz

1
Brief

You send the product, pack, market and volume, and whether you supply the bulk.

2
Shortlist with approvals

Packaging sites with the right licence, lines and serialisation, with their approvals. Names under a confidential disclosure agreement when the requirement is firm.

3
Artwork and materials

Artwork approval, printed materials and pack specifications.

4
Validation and first run

Line set-up, first packing run and documentation for your dossier where needed.

5
Release

Batch packing record, reconciliation and release documents; pre-shipment inspection on request.

6
Repeat runs

Scheduled packing with version-controlled artwork.

Problems we see most often

Wrong artwork version on a batch

Usually weak artwork control. Ask how versions are approved, issued to the line and reconciled.

Pack that fails stability in the market

A cheaper blister was used than the one in the stability study. Keep the pack specification locked to the registered one.

Serialisation that the importer cannot read

Codes in the wrong format or not uploaded to the right system. Agree the data format with the importer before the first run.

Need a packing or relabelling partner?

Send the product, pack type, market and volume. We will tell you which packaging sites fit and what documents they hold.

Send your requirement Talk to our team

Frequently Asked Questions

A licensed site packs medicines into their primary packs (blisters, bottles, sachets) and secondary packs (cartons and leaflets) for a brand owner or manufacturer, under GMP.

Yes. Packing a medicine into its primary container is a manufacturing activity under Indian drug law, so the site needs a manufacturing licence covering that dosage form and must follow GMP.

It depends on the market. India requires barcodes on export packs, the EU requires a unique identifier and anti-tampering device on prescription medicines, and the US requires serialised product identifiers under the DSCSA. Many other countries now have their own systems.

Yes, where a licensed packaging site can take in your bulk with its documents. The bulk manufacturer and the packer both usually appear in the dossier.

The one your stability data supports. PVC/PVdC suits most products in hot, humid markets; Alu-Alu is used for moisture- or light-sensitive products.

We handle artwork through the packaging site and your regulatory requirements. Brand design itself is usually done by your own agency.

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