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Third Party Pharmaceutical Manufacturing in India — Complete Guide for Pharma Businesses
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Aarise Pharmaceuticals is a WHO GMP certified third party pharmaceutical manufacturer based in Haridwar, India. We manufacture finished pharmaceutical formulations and APIs for international brands, generic companies, and distributors across 18 countries including USA, Germany, Brazil, Mexico, Colombia, and South Korea.
Looking for a reliable third party pharma manufacturer in India?
Call us: +91 9899783330 | +91 9289410333
Or Request a Quote → — we respond within 24 hours.
What is Third Party Pharmaceutical Manufacturing?
Third party pharmaceutical manufacturing (also called contract manufacturing or loan license manufacturing) is a business arrangement where a certified manufacturer produces pharmaceutical products on behalf of another company — under that company’s brand name, specifications, and regulatory requirements.
The brand owner provides the formula, branding, and target market requirements. The manufacturer handles production, quality control, regulatory documentation, and packaging.
Why international companies choose third party manufacturing in India:
- Manufacturing costs 30–50% lower than USA or Europe
- WHO GMP certified facilities meeting international standards
- No capital investment in manufacturing infrastructure
- Faster time to market — first batch in 15–20 days
- Full regulatory documentation for your target market
- Scalable — start with 10,000 units, scale to crores
Aarise Pharmaceuticals — Third Party Manufacturing Services
Facility: Haridwar, Uttarakhand, India (SIDCUL Industrial Area)
Certification: WHO GMP Certified
Capacity: 50+ crore tablets annually
Quality Lab: NABL-accredited in-house QC
Formulations: 58+ product formulations available
Turnaround: 15–20 days for first batch after approval
Dosage Forms Available for Contract Manufacturing
| Dosage Form | Examples | MOQ |
|---|---|---|
| Tablets (coated/uncoated) | All standard molecules | 10,000 units |
| Dispersible Tablets | Paracetamol, Amoxicillin, Ibuprofen | 10,000 units |
| Capsules (hard gelatin) | All standard molecules | 10,000 units |
| Oral Liquids | Syrups, suspensions, drops | 5,000 units |
| Ointments & Creams | Topical formulations | 5,000 units |
| Injections | Ampoules, vials | 10,000 units |
| External Applications | Gels, lotions | 5,000 units |
Custom formulations available on request. Stability testing and shelf-life documentation provided.
Documentation We Provide with Every Order
Every third party manufacturing order from Aarise includes:
- Certificate of Analysis (COA) — batch-specific
- Material Safety Data Sheet (MSDS)
- WHO GMP Certificate (facility)
- Stability data and shelf-life documentation
- Packaging and labelling as per your market requirements
- Export documentation (commercial invoice, packing list, COO)
Additional documentation on request: DMF support, COPP, regulatory dossier for target market.
Exporting Third Party Manufactured Products — By Market
USA USA (FDA)
For pharmaceutical products entering the US market, Aarise provides:
- cGMP compliant manufacturing (WHO GMP equivalent)
- Drug Master File (DMF) support for ANDA/NDA submissions
- FDA-format COA and stability data
- Labelling compliant with 21 CFR requirements
Products manufactured at our facility have been exported to US-based distributors and pharma companies. We support your regulatory team through the submission process.
Germany / EU Germany / EU (EMA / BfArM)
- EU GMP equivalent documentation
- EDQM CEP support where applicable
- COA and MSDS in EU-required format
- Regulatory dossier support for BfArM / EMA submissions
Brazil Brazil (ANVISA)
- ANVISA-format COA and technical dossier
- Portuguese labelling available
- Brazilian import documentation support
- IFA (Ingrediente Farmacêutico Ativo) supplier documentation
Mexico Mexico (COFEPRIS)
- COFEPRIS-compatible documentation package
- Spanish labelling available
- COA, MSDS, stability data in required format
Colombia Colombia (INVIMA)
- INVIMA documentation support
- Full compliance package available on request
South Korea South Korea (MFDS)
- MFDS-compatible quality documentation
- COA and GMP certificate in required format
How Third Party Manufacturing Works at Aarise
Step 1 — Inquiry
Share your product requirement: molecule name, dosage form, strength, target market, and annual volume estimate. Contact us at +91 9899783330 or fill the inquiry form.
Step 2 — Formulation Agreement
We share our existing formulation or develop a custom one per your specification. Technical data sheet and COA for the formulation provided.
Step 3 — Regulatory Review
We confirm all regulatory requirements for your target market and prepare the documentation package.
Step 4 — Sample Batch
A sample batch is manufactured and full QC testing completed. COA issued. You verify in your own lab before approving bulk production.
Step 5 — Bulk Production
Full batch manufactured, QC cleared, packed as per your requirements, and shipped with complete documentation.
Step 6 — Ongoing Supply
Regular supply schedule established. Dedicated account manager for reorders and documentation updates.
Why Choose Aarise Over Other Indian Third Party Manufacturers?
| Factor | Aarise Pharmaceuticals | Typical Indian CMO |
|---|---|---|
| Certification | WHO GMP Certified | Varies |
| QC Lab | NABL-accredited in-house | Often outsourced |
| Export experience | 18 countries | Often domestic only |
| Turnaround | 15–20 days first batch | 30–60 days |
| Documentation | Full regulatory package | Basic COA only |
| MOQ | From 10,000 units | Often 50,000+ |
| Market support | USA, EU, LATAM, Asia | India-focused |
Selection Criteria — What to Check Before Choosing a Third Party Manufacturer
When evaluating any Indian third party manufacturer, verify:
Aarise Pharmaceuticals meets all of the above. Request our compliance documentation →
Frequently Asked Questions
What is the difference between third party manufacturing and pharma franchise?
Third party manufacturing = you own the brand, we manufacture under your name. Pharma franchise = you sell our branded products in your territory. Both are available at Aarise.
What is the minimum order quantity?
Typically 10,000 units for tablets and capsules, 5,000 units for liquids. Lower MOQs available for sample/trial orders — contact us to discuss.
Can you manufacture for export to regulated markets (USA, EU)?
Yes. We provide full regulatory documentation for USA (FDA/cGMP), EU (EMA/GMP), and other regulated markets. DMF support available.
How long does it take to start production?
First batch: 15–20 days after formulation approval and regulatory clearance. Reorders: 7–10 days.
Do you provide custom packaging and labelling?
Yes. We manufacture and pack as per your brand specifications including country-specific labelling requirements.
What quality certifications does Aarise hold?
WHO GMP Certification, ISO 9001:2015, NABL-accredited quality control laboratory.
Can I visit the facility before placing an order?
Yes. We welcome facility visits and virtual audits for international buyers. Contact us to schedule.
Request a Third Party Manufacturing Quote
Tell us:
- Product name / molecule
- Dosage form and strength
- Target market / country
- Estimated annual volume
We respond within 24 hours.
+91 9899783330 | +91 9289410333
aarisepharma.com
Aarise Pharmaceuticals | WHO GMP Certified Third Party Pharmaceutical Manufacturer | Haridwar, India