HDPE Tablet Bottle USP

Item No	Capacity	Height	Diameter of Body	Neck Finish	Weight
GT 31	45ml	61.8 mm	37.8 mm	33-400	7.6g
GTN 60(No Img)	60ml	70.71mm	39.88 mm	33-400	10g
GT 127	50ml/60ml	68.5 mm	38.6 mm	33-400	9.9g
GT 32	75ml	75.5 mm	43.4 mm	33-400	10g
GT 35	85ml	82.0 mm	44.4 mm	33-400	10g
GT 95	100ml	82.0 mm	47.5 mm	38-400	13.8g
GTS 100(No Img)	100ml	78 mm	47 mm	38-400	25.3g
GT 28	120ml	88.5 mm	50.4 mm	38-400	16g
GT 23	150ml	93.0 mm	53.6 mm	38-400	18.3g
GT 216	175ml	98.5 mm	55.4 mm	38-400	18.4g
GT 51	200ml	106.2 mm	58.5 mm	43-400	22g
GT 77	250ml	113.8 mm	62.5 mm	43-400	25.4g
GTS 250	250ml	103.5mm	66.68 mm	53-400	40g
GT 52	300ml	126.5 mm	65.2 mm	43-400	27.9g
GT 50	400ml	130.7 mm	72.6 mm	52-400	33.5g
GT 50-A	500ml	147.5 mm	75.5 mm	52-400	36.6g
GT 226	750ml	171.9 mm	86.1 mm	53-400	47g
GT 126	950ml	165.1mm	98.4 mm	53-400	80g

What You Get

One Validated Container Closure System, Not Loose Components

Every bottle in our range is supplied with a matched closure and liner that have been dimensionally and functionally verified together. You receive a complete container closure system ready for your stability program, not a bottle from one supplier and a cap from another.

Closure Options

Child-Resistant (CRC) — Push-and-turn or squeeze-and-turn. Tested to 16 CFR 1700.20. Senior-friendly open. Continuous Thread (Non-CR) — Standard screw cap for markets without CR requirements. Desiccant Closures — Integrated silica gel or molecular sieve, [1–3] g, for moisture-sensitive formulations. Liners — Induction seal (one-piece or two-piece), pressure-sensitive, or foam. Tamper-evident on all induction options.

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Registered, Tested, Documented

Drug Master Files US FDA Type III DMF — HDPE bottles& Closures: DMF No. 26421 Letter of Authorization issued within 5 business days of request	Child-resistance Certification 16 CFR 1700.20 (US CPSC protocol) Third-party test reports available for CRC design
Material Compliance USP <661.1> Plastic Materials of Construction and <661.2> Plastic Packaging Systems FDA 21 CFR 177.1520 (polyolefins) and 177.1630 (PP closures) Resin and colorant declarations available	Quality Management Systems ISO 15378 — GMP for primary packaging materials for medicinal products ISO 9001 — Quality management Cleanroom classification ISO 8

The Dossier Your QA Team Needs is Ready today

• USP <661.1>, <661.2> | Bottle, closure, liner | Test report
• USP <671> | Bottle-closure system | Test report
• 16 CFR 1700.20 | CRC | Third-party report
• ISO 15378 | Facility | Certificate
• ISO 9001 | Facility | Certificate

Know What Was Tested Before the Shipment Arrives

Incoming: Resin MFR, density, FTIR identity — wrong resin never reaches the machine In-process: Every 2 h: weight, wall, neck, thread, visual · 100% vision inspection catches what sampling misses Final: Leak, torque, seal strength, CRC function, drop Type testing: USP <661> <671>, CRC, ESCR — annually and after any change, so your file stays current Lab: Torque, leak, MVTR, CMM, FTIR, environmental chamber · third-party: SGS Cleanroom: ISO 8, positive pressure, routine particle and microbial monitoring Per batch: CoA with measured values. Not “conforms.” Numbers.

Traceability | From Resin Lot to Your Purchase Order

Hand us any bottle or closure from any shipment. We will return the complete record — resin lot, production batch, inspection data, retained sample — within 48 hours.

Raw Material

• Resin grade locked to (supplier + grade name).
• Every resin lot CoA archived and linked to production batches.
• Colorant and foil liner traced to lot level.

Production

• Each production batch carries a unique lot number linked to mold ID, cavity number, machine, date, shift and operator.
• Cavity number molded into bottle base and closure interior — dimensional issues can be isolated to a single cavity.

Inspection & Retention

• IPQC and FQC records retrievable by lot number.
• Retained samples from every batch, held for 3 year.

Shipment

• Carton label: lot number, quantity, production date.
• One lot per carton, no mixed lots.

Built to Pass Your Supplier Qualification Quickly

We know how pharmaceutical supplier qualification works. The documents are ready, the facility is open, and the quality agreement is negotiable. Our goal is to shorten your approval cycle, not add to it.
We’ve Been Audited by US/EU Pharma. We Know What You’ll Ask.Most supplier approvals stall on paperwork, not product. Ours doesn’t:

• Supplier questionnaire returned in 5-7 business days, complete
• Document pack ready now: licenses, ISO certificates, DMF, facility layout, org chart, quality manual index
• On-site or remote audit — any area, any day, with pre-audit package sent in advance
• Full quality system with procedures and records: document control, training, calibration, deviation, CAPA, change control, supplier management
• We sign your quality agreement, not just ours

FAQ

Can we reference your DMF in our application?

On-site, remote live video, and document-based. Supplier questionnaires are returned within 5-7 business days.

Can we buy bottles and closures separately?

Yes. However, we recommend the validated pair. If you use another supplier’s closure or bottles, we will provide neck finish drawings for your compatibility check.

Are samples free?

Standard samples are free; you cover freight. We support line trials and can supply 200-500 pcs (or your request) for filling-line validation.

What audit formats do you support?

On-site, remote live video, and document-based. Supplier questionnaires are returned within 5-7 business days.

Do you provide measured values on the CoA?

Yes. Every CoA shows actual measured results against specification, not just pass.

Which cleanroom class is your production?

ISO 8  with continuous pressure monitoring and scheduled environmental monitoring.

Will you notify us before changing resin, molds or process?

Yes. Written notification with impact assessment is issued before any change. This is written into our quality agreement.