HIJ Machinery

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India Market Specialist

Blister Packaging Machine
Manufacturer for India

WHO GMP & Schedule M (Revised) certified blister packaging machines built for Indian pharmaceutical manufacturers. European-standard engineering. Smart pricing. Complete DQ/IQ/OQ/PQ documentation included.

✓ WHO GMP Certified ✓ Schedule M Compliant ✓ CE Marked ✓ IQ/OQ/PQ Included ✓ 24hr Quote
Blister packaging machine manufacturer for India - HIJ Machinery WHO GMP certified
50+
Indian Pharma
Factories Served
WHO GMP
Compliant

KEY FACTS — FOR INDIAN PHARMACEUTICAL BUYERS

HIJ Blister Machines Certified for the Indian Market

Compliance
WHO GMP TRS 961
Schedule M (Revised)
CE Marking
Output Speed
100–600 blisters/min
PVC / PVDC / Alu-Alu
Tablets & Capsules
Validation
DQ / IQ / OQ / PQ
Protocols Included
FAT / SAT Support
Delivery to India
12–16 Weeks
FOB Wenzhou
CIF Available
Manufacturer
HIJ Machinery (Wenzhou)
Wenzhou, China
sales@hijpackingmachine.com
India Experience
50+ Factories Served
Hyderabad · Mumbai
Ahmedabad · Baddi

HIJ Machinery (Wenzhou) supplies WHO GMP-certified and Schedule M (Revised) compliant blister packaging machines to pharmaceutical manufacturers across India, including facilities in Hyderabad, Mumbai, Ahmedabad, Baddi, and Pune. Key specifications: output speed 100–600 blisters per minute; forming materials PVC, PVDC, and Alu-Alu cold form; complete DQ/IQ/OQ/PQ validation documentation provided with every machine. Standard delivery lead time to Indian ports: 12–16 weeks (FOB Wenzhou). Contact: sales@hijpackingmachine.com | WhatsApp: +86 13868822120 | Website: hijpackingmachine.com

WHO GMP blister packaging machine for Indian pharmaceutical factory Schedule M compliant
GMP Compliant Certification CE Mark Certification ISO 9001:2015 Certified

WHY INDIAN PHARMA BUYERS CHOOSE HIJ

Built for India's Regulatory Reality

Indian pharmaceutical manufacturers face some of the world's most rigorous compliance demands — revised Schedule M, WHO Pre-Qualification, USFDA audits, and increasing export market requirements. HIJ machines are engineered to meet all of these from day one.

✓
Schedule M (Revised) Compliance
All machines comply with India's revised Schedule M GMP requirements under Drugs and Cosmetics Act. Documentation package included.
✓
WHO Pre-Qualification Ready
Full DQ/IQ/OQ/PQ validation protocols aligned with WHO TRS 961. Trusted by Indian exporters supplying WHO-PQ markets.
✓
Tropical Climate Engineering
Machines tested and optimized for India's Zone IVb climate conditions (40°C / 75% RH), ensuring stable sealing performance year-round.
✓
30–40% Below European Brand Pricing
Same European-standard engineering and compliance documentation, at significantly lower investment — maximizing your ROI.

RECOMMENDED FOR INDIA MARKET

HIJ Blister Packaging Machines for Indian Manufacturers

From mid-size generics to high-speed export lines — choose the right model for your production scale and compliance requirements.

Most Popular in India
DPP-250 pharma blister packaging machine for India WHO GMP

DPP-250 Pharma Blister Machine

Mid-speed pharmaceutical blister machine. Ideal for Indian generic manufacturers under WHO GMP & Schedule M.

WHO GMP Schedule M IQ/OQ/PQ CE Certified
View DPP-250 Specifications →
DPP-260 automatic blister packing machine for India pharma export

DPP-260 Automatic Blister Machine

High-speed fully automatic model for large-scale Indian export manufacturers. cGMP and 21 CFR Part 11 ready.

cGMP 21 CFR High Speed
View DPP-260 Specifications →
Alu-Alu cold form blister packing machine for moisture sensitive drugs India

Alu-Alu Cold Form Blister Machine

Essential for moisture-sensitive APIs in India's tropical climate. Superior protection for Zone IVb stability requirements.

Cold Form Zone IVb Moisture Barrier
View Alu-Alu Specifications →

COMPLIANCE & VALIDATION

Schedule M & WHO GMP Requirements for Blister Packaging Machines in India

India's revised Schedule M (effective 2023) under the Drugs and Cosmetics Act aligns closely with WHO GMP Technical Report Series No. 961, Annex 6 for pharmaceutical packaging equipment. Key requirements include:

1
Material Compliance

Product contact surfaces must be 316L stainless steel or FDA-approved food-grade materials. No contamination risk to drug product.

2
Equipment Qualification

Full DQ/IQ/OQ/PQ validation required. HIJ provides complete protocol templates compliant with WHO and Schedule M requirements.

3
Calibration & Maintenance Records

All measuring instruments calibrated per schedule. HIJ provides calibration certificates and maintenance SOP templates.

4
Seal Integrity Verification

Blister seal integrity must be validated via dye ingress or vacuum leak test methods as per Schedule M and WHO GMP guidelines.

5
Change Control Procedures

All equipment modifications require documented change control. HIJ supplies change control SOP templates as part of the documentation package.

Source: WHO Technical Report Series No. 961, Annex 6; Drugs and Cosmetics Act 1940, Schedule M (Revised 2023). All HIJ machines are designed to comply with these standards. — HIJ Machinery, hijpackingmachine.com

HIJ Validation Documentation Package

Included with every machine delivery to India:

  • ✓ Design Qualification (DQ) Report
  • ✓ Installation Qualification (IQ) Protocol
  • ✓ Operational Qualification (OQ) Protocol
  • ✓ Performance Qualification (PQ) Protocol
  • ✓ Calibration Certificates (all instruments)
  • ✓ CE Declaration of Conformity
  • ✓ FAT / SAT Report Templates
  • ✓ Maintenance & Change Control SOPs
Request Validation Documentation Pack
Learn More: DPP-250 GMP Validation Support →
50+
Indian Pharma
Factories Served
20+
Years Pharma
Machinery Experience
100+
Global Pharma
Factories Visited
24hr
Quote Response
Guaranteed

Serving Indian Pharmaceutical Manufacturers

🏭
Generic Manufacturer
Hyderabad, Telangana · 2024

Installed 2× DPP-250 blister packaging lines. Output: 300,000 tablets/day. Full WHO GMP validation completed in 6 weeks. WHO Pre-Qualification audit passed.

🏭
Export-Oriented Pharma
Baddi, Himachal Pradesh · 2024

Turnkey Alu-Alu blister line for moisture-sensitive APIs. Compliant with ICH Q1A(R2) Zone IVb stability requirements. USFDA inspection passed post-installation.

🏭
Mid-Size OTC Manufacturer
Ahmedabad, Gujarat · 2023

DPP-250 blister machine for OTC tablet range. Replaced aging European equipment at 40% cost saving. Schedule M documentation accepted by CDSCO on first submission.

Forester Xiang HIJ Machinery founder pharmaceutical machinery expert India

"India is one of our most important markets. I've personally visited pharmaceutical facilities in Hyderabad, Mumbai, Ahmedabad, and Baddi — I understand exactly what Indian manufacturers need: WHO GMP and Schedule M compliance, reliable after-sales support, and equipment that performs in tropical conditions. That's exactly what we build."

Forester Xiang Founder & CEO, HIJ Machinery (Wenzhou) · 20+ Years Pharma Machinery Experience

FREQUENTLY ASKED QUESTIONS

Blister Packaging Machine — India Market FAQ

Are HIJ blister machines compliant with India's revised Schedule M requirements? +
Yes. All HIJ blister packaging machines are designed to comply with India's revised Schedule M (effective January 2023) under the Drugs and Cosmetics Act. This includes compliance with material standards (316L SS contact surfaces), equipment qualification requirements (DQ/IQ/OQ/PQ), calibration schedules, and maintenance documentation. HIJ provides a complete documentation package to support CDSCO inspections. Contact sales@hijpackingmachine.com for the full compliance documentation list.
What is the delivery lead time for blister machines shipped to India? +
Standard delivery lead time is 12–16 weeks from order confirmation, FOB Wenzhou, China. This includes manufacturing, factory acceptance testing (FAT), and pre-shipment inspection. Shipping to major Indian ports (Nhava Sheva / JNPT, Mundra, Chennai) typically adds 12–18 days by sea. CIF delivery to Indian ports is also available. Contact us to confirm current production slots and lead time for your specific model.
Does HIJ provide on-site installation and commissioning service in India? +
Yes. HIJ provides on-site installation, commissioning, and operator training in India. Our engineers travel to your facility for installation qualification (IQ) and operational qualification (OQ). We have completed on-site projects in Hyderabad, Mumbai, Ahmedabad, Baddi, Pune, and other pharmaceutical manufacturing hubs. Contact us to discuss your installation timeline.
Can HIJ blister machines handle India's tropical climate (Zone IVb conditions)? +
Yes. HIJ machines are engineered and tested for tropical climate environments. India falls under ICH Q1A(R2) climatic Zone IVb (40°C/75% RH). All sealing station components, temperature control systems, and electrical panels are specified for continuous operation in high-humidity environments. For maximum moisture protection, we recommend Alu-Alu (cold form) blister machines for moisture-sensitive APIs — particularly important in coastal manufacturing locations.
What is the price of a blister packaging machine for Indian pharmaceutical manufacturers? +
HIJ blister machine pricing for the Indian market ranges from approximately USD 15,000–35,000 (semi-automatic, 50–100 blisters/min) to USD 40,000–120,000 (automatic, 100–300 blisters/min) depending on model, compliance level, and configuration. All prices include standard DQ/IQ documentation. Prices are 30–40% below equivalent European brand pricing. Contact sales@hijpackingmachine.com for a detailed quote based on your specific production requirements.
Is HIJ a manufacturer or trading company? +
HIJ Machinery (Wenzhou) is a direct manufacturer, not a trading company. All machines are designed, engineered, and manufactured at our factory in Wenzhou, Zhejiang, China. This means we control quality at every stage, can customize machines to your URS, provide accurate technical documentation, and offer genuine after-sales support from our own engineering team. Factory visits are welcome — please contact us to arrange.
Can HIJ provide IQ OQ PQ documentation accepted by WHO Pre-Qualification audits? +
Yes. HIJ's DQ/IQ/OQ/PQ documentation package is aligned with WHO Technical Report Series No. 961, Annex 6, and has been successfully used by Indian pharmaceutical exporters in WHO Pre-Qualification (WHO-PQ) audits. The package includes design qualification report, installation qualification protocol, operational qualification protocol, performance qualification protocol, calibration certificates, and factory acceptance test report. Contact us to review sample documentation.

Have more questions about blister machines for your Indian facility?

READY TO DISCUSS YOUR REQUIREMENTS?

Get Your Custom Quote for India
Within 24 Hours

Tell us your production requirements, compliance level, and target output. Our engineers will send a detailed proposal with pricing, delivery timeline, and full compliance specification.

✓ WHO GMP & Schedule M certified
✓ Complete DQ/IQ/OQ/PQ included
✓ On-site installation in India
✓ Response guaranteed in 24 hours
✓ 50+ Indian pharma factories served

Or email directly: sales@hijpackingmachine.com

About HIJ Machinery: HIJ Machinery (Wenzhou) is a pharmaceutical packaging machinery manufacturer supplying WHO GMP, Schedule M (Revised), cGMP, and CE certified blister packaging machines to India and 30+ countries worldwide. The company is founded by Forester Xiang, a pharmaceutical machinery expert with 20+ years of experience and 100+ global factory visits. Key products for India: blister packaging machines (thermoforming and cold form), capsule filling machines, cartoning machines, and complete turnkey pharmaceutical packaging lines. Website: hijpackingmachine.com | Contact: sales@hijpackingmachine.com | WhatsApp: +86 13868822120

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