WHO-GMP Certified
Pharmaceutical Contract
Manufacturing from India
India supplies 20% of the world’s generic medicines. Jireh Nutrition Hub is part of that backbone — a WHO-GMP and ISO 9001:2015 certified pharmaceutical contract manufacturer operating a dedicated 60,000 sq ft facility built for regulated export markets in the USA, UK, Europe, Middle East, and beyond. Tablets, capsules, syrups, sterile injectables, and topical formulations — all under one roof.
India Manufactures
20% of the World’s
Generic Medicines.
That statistic is not incidental. It reflects decades of pharmaceutical-grade manufacturing infrastructure, a workforce trained to WHO-GMP and US FDA standards, a cost structure that is 40–60% below equivalent Western production, and a regulatory ecosystem specifically built for global pharmaceutical export.
Jireh Nutrition Hub’s pharmaceutical manufacturing unit was built to operate within that infrastructure while eliminating the gap that has historically frustrated international buyers — the absence of a single, accountable, documentation-fluent partner that can take a product from API sourcing to customs-cleared finished goods without losing compliance integrity at any step.
When your brand sources pharmaceutical contract manufacturing from our WHO-GMP certified facility in India, you are not making a cost compromise. You are accessing a supply chain that powers a significant share of the world’s medicine supply — at the price point that makes global health brands viable.
Every Pharmaceutical
Dosage Form.
One Certified Facility.
Our 60,000 sq ft pharmaceutical manufacturing unit houses five dedicated production departments — oral solid dosage, hard-shell capsule filling, liquid manufacturing, sterile injectables, and topical formulations. Each operates under independent GMP-controlled environments with dedicated IPQC monitoring and batch release protocols.
High-volume tablet compression using rotary compression machines with automated weight-variation monitoring. Film-coating in fully enclosed perforated coating pans with precise inlet air temperature, spray rate, and pan speed controls. Immediate-release, sustained-release, enteric-coated, bilayer, and effervescent tablet formats available. Custom debossing, scoring, and film-coat colors for branded product differentiation. Production compliant with WHO-GMP Schedule M and US FDA 21 CFR Part 211 standards. Full dissolution, disintegration, and friability testing per batch.
Pharmaceutical-grade hard-shell capsule manufacturing using high-speed automated capsule filling machinery. Hard gelatin (bovine, porcine), HPMC (hydroxypropyl methylcellulose) vegetarian, and modified-release capsule shells available. Immediate-release, delayed-release, and extended-release profiles achievable through pellet, mini-tablet, or powder-fill technologies. Liquid-filled hard capsule (LFHC) format available for lipid-based drug delivery systems. Precision fill weights with ±2% tolerance. Capsule printing and banding available for tamper evidence and brand identification. Complete dissolution, disintegration, and content uniformity testing per batch.
Dedicated pharmaceutical liquid manufacturing suite with stainless steel SS316L mixing vessels, in-line homogenisers, and automated filling-sealing lines. Oral solutions, syrups, suspensions, elixirs, drops, and dry syrup reconstitution powders manufactured under controlled microbial environment conditions. Allergen separation protocols in place. Cold-chain production capabilities available for temperature-sensitive actives. Complete pH, viscosity, density, microbial limits, and assay testing per batch. Sugar-free and sucrose-based formulation options. Bottle, sachet, and unit-dose ampoule filling available.
Sterile injectable manufacturing in ISO Class 5 (Grade A) laminar airflow fill-finish suites within ISO Class 7 (Grade B) background cleanroom environments. Aqueous solutions, suspensions, and lyophilised (freeze-dried) injectable products. Small-volume parenteral (SVP) manufacturing in glass vials, ampoules, and pre-filled syringes. Sterilisation by membrane filtration (0.22 μm) for aseptically-filled products. Terminal sterilisation by validated autoclave cycles for eligible formulations. Environmental monitoring, sterility testing, endotoxin testing, and particulate matter analysis on every batch. WHO-GMP cleanroom standards maintained with continuous environmental monitoring protocols.
Dedicated semi-solid manufacturing suite for dermatological and topical pharmaceutical product categories. Creams, ointments, gels, lotions, and pastes manufactured using temperature-controlled mixing systems with homogenisation capability for stable emulsion formation. Water-in-oil and oil-in-water emulsion systems. Medicated, cosmeceutical, and OTC topical formulations. Tube, jar, pump, and airless dispenser fill formats. Viscosity, pH, spreadability, microbial limits, preservative efficacy, and assay testing per batch. Dermatologically tested formulations available. Suitable for export to USA (OTC Monograph compliance), EU, UK, and Gulf markets.
60,000 Sq Ft Built
for Pharmaceutical-Grade
Production Precision
Our pharmaceutical manufacturing unit is not a converted or retrofitted general-purpose facility. It was purpose-built for pharmaceutical production — with dedicated departments, validated environmental controls, and cleanroom infrastructure that meets WHO-GMP and US FDA architectural and engineering standards from the ground up.
Certified to Enter
Every Major
Pharmaceutical Market
Our WHO-GMP, ISO 9001:2015, and US FDA compliant certifications provide the regulatory access credentials that pharmaceutical distributors and brand owners require to import and register products in the world’s most demanding pharmaceutical markets. Each market has distinct documentation requirements — we know all of them, and we produce the right paperwork before your shipment leaves India.
US FDA registered facility infrastructure. 21 CFR Part 211 cGMP compliance for pharmaceutical manufacturing. OTC Monograph-compliant formulations and labelling. Full supplement facts and drug facts label production capability. Amazon and retail-ready documentation packages.
EU GMP Annex-aligned manufacturing processes. EU Novel Food Regulation documentation support for applicable botanical and nutraceutical ingredients. CEP (Certificate of Suitability) support for API products. UK MHRA compliance documentation. CE marking support for medical devices/borderline products.
WHO-GMP certification is the primary regulatory credential for pharmaceutical import approval across UAE Ministry of Health, Saudi SFDA, and GCC Drug Regulatory Authority registration pathways. COPP (Certificate of Pharmaceutical Product) issued through CDSCO. Halal certification available for GCC market requirements.
TGA (Therapeutic Goods Administration) compliance documentation package for Australian market product registration. Health Canada NPN (Natural Product Number) support for complementary medicines. ANDS (Abbreviated New Drug Submission) documentation assistance for pharmaceutical products.
WHO-GMP certification enables straightforward pharmaceutical import registration across African and Asian markets that follow WHO prequalification pathways. NAFDAC (Nigeria) and KEBS (Kenya) registration documentation support. Southeast Asian market registration assistance for Philippines FDA, BPOM (Indonesia), and HSA (Singapore).
Active export partnerships with pharmaceutical distributors across Latin America (Mexico, Brazil, Colombia), CIS countries (Kazakhstan, Uzbekistan), and MENA region (Egypt, Jordan, Iraq). ANVISA (Brazil) registration documentation support. All export documentation packages include Certificate of Analysis, Certificate of Origin, and MSDS as standard.
No Batch Ships
Without Complete
QA Sign-Off
Our Quality Assurance department operates independently from production — not as a support function, but as a gate-keeping authority. No batch is released without QA-authorised sign-off following complete analytical and microbiological verification. This is not a procedural formality. It is the structural mechanism that ensures every unit that leaves our facility is exactly what the label says it is.
Every finished pharmaceutical product batch undergoes the following analytical and microbiological testing before QA release authorisation is granted:
Manufacturing Services
for Every Brand Stage
Whether you are entering the pharmaceutical space for the first time or scaling an established distribution network into new regulated markets, our service models are structured to meet you at your current stage — and grow with you as your volumes increase.
Your brand identity on finished, market-ready pharmaceutical products. We handle API sourcing, formulation, stability testing, packaging design, regulatory-compliant labelling for your destination market, and finished goods delivery — all under your brand name and with full ownership documentation.
Start Your Brand →You own the formulation. We manufacture it under full confidentiality with dedicated production runs, batch traceability, and complete BMR documentation. The right choice for pharmaceutical brands with validated proprietary formulations that need WHO-GMP certified scale-up production in India.
Get Pricing →High-volume pharmaceutical production runs for distributors, trading houses, and established pharmaceutical brands requiring reliable WHO-GMP compliant supply under their existing brand names. Preferred by brands entering new geographic markets without establishing local manufacturing infrastructure.
Enquire Now →Our pharmaceutical R&D team develops novel drug formulations based on your target therapeutic indication, API selection, and destination market regulatory requirements. From pre-formulation studies through process development, scale-up validation, and regulatory submission support — we handle the science.
Submit R&D Brief →Direct supply of pharmaceutical-grade APIs, excipients, and intermediates to manufacturers and formulators globally. All materials sourced from CDSCO-approved Indian API manufacturers. Full Certificate of Analysis, MSDS, Certificate of Origin, and phytosanitary documentation included with every shipment.
Request Samples →Compressed tablets, filled capsules, or filled-but-unpackaged vials — manufactured to your specification and delivered ready for your final packaging stage. Reduces your time-to-market significantly for pharmaceutical brands that have local packaging infrastructure but require GMP-compliant semi-finished supply from India.
Get Pricing →We Handle Every
Document Your Regulatory
Team Needs
Failed customs clearances and regulatory rejections are almost never caused by product quality failures. They are caused by incomplete, incorrectly formatted, or market-incompatible documentation. Our documentation team ensures every export shipment is accompanied by the complete, correct, market-specific regulatory package — before it leaves our facility.
All Batch Manufacturing Records, Standard Operating Procedures, Equipment Qualification records, Validation Master Plans, and QA documentation are current, complete, and retrievable within minutes of an audit request. Data integrity protocols align with WHO technical guidelines and US FDA 21 CFR Part 211 expectations. No data retroactive entry. No incomplete records. Audit trail maintained across all systems.
Physical facility is maintained to inspection standard daily — not only when an audit is scheduled. HVAC validation, equipment calibration status, environmental monitoring results, and cleaning validation records are current and accessible. Corrective and Preventive Action (CAPA) system maintains full closure documentation for all previous findings. No open critical or major observations at our last audit cycle.
All manufacturing and QA personnel hold current training certifications for their role-specific SOPs, GMP principles, and safety protocols. Training matrices are maintained per employee with documented retraining intervals. Qualification records for key personnel — QA Manager, Production Manager, Microbiologist — available for auditor review. Virtual audit protocol available for remote inspection by appointed inspection agencies.
Low MOQs for
Market Validation.
Scale When You’re Ready.
Our minimum order quantities for pharmaceutical contract manufacturing are designed to support brands at every stage — from initial market validation through to full-scale supply chain establishment. The same WHO-GMP quality standards, the same batch documentation, and the same CoA package apply at every volume level.
- Market entry validation batches
- Regulatory submission samples
- Retailer and distributor samples
- Full WHO-GMP production applies
- Complete CoA & BMR included
- Optimal cost per unit achieved
- Full export documentation
- Custom packaging and labelling
- Priority production scheduling
- Stability data available on request
- Maximum unit economics
- Dedicated production scheduling
- Long-term supply agreements
- Warehousing & dispatch coordination
- Direct container FCL shipment
Questions Pharmaceutical
Brands Ask Before
Partnering with Us
These are the questions we receive most consistently from pharmaceutical distributors, brand owners, and sourcing managers evaluating Jireh Nutrition Hub as their Indian contract manufacturing partner. If your question is not answered here, contact us directly — our compliance team responds within 24 hours.
Ready to Source
Pharmaceutical Products from
India’s WHO-GMP Network?
Whether you are a pharmaceutical distributor entering a new market, a brand owner transitioning your manufacturing to India, or a healthcare company seeking a WHO-GMP certified Indian CDMO — this is where your sourcing relationship begins. Submit your enquiry and receive a formal capability overview, product portfolio, and indicative pricing within 24 hours. No commitment required.
Or reach us directly: director@shandaniel.com