Contract pharmaceutical manufacturing facility

Contract & Third-Party Manufacturing

We Manufacture Your Products Under Your Brand

Beyond exporting our own portfolio, Tuli Enterprise gets your pharmaceutical and nutraceutical products manufactured to your specification — through a network of facilities accredited by the USFDA, EU-GMP, UK MHRA, TGA, Health Canada, PMDA, WHO-GMP and PIC/S. From custom formulation and dossiers to private-label packaging, export documentation and door-to-door shipping, we handle everything.

Everything We Do For You

A Complete End-to-End Manufacturing Partner

Whether you are a distributor, importer, hospital group, pharmacy chain or a new brand owner, we turn your product idea into finished, export-ready goods. You focus on your market — we manage sourcing, formulation, accredited manufacturing, quality control, regulatory documentation and global logistics.

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Custom Formulation

New product development, reformulation and line extensions tailored to your market.

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Private Labeling

Your brand, artwork, packaging and multi-language labels.

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Regulatory Dossiers

CTD / ACTD dossiers, COPP, COA and full registration support.

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Export & Logistics

Documentation, cold-chain and shipping to your destination port.

Accreditations

Manufacturing at Globally Accredited Facilities

Every product is manufactured at facilities holding stringent international accreditations. We select the site that matches your target market’s regulatory requirement — these approvals are held by our manufacturing partners.

Stringent Regulatory Authorities (SRA) & Global Standards

USFDA
U.S. Food & Drug Administration
United States
EU-GMP
European Medicines Agency GMP
European Union
UK MHRA
Medicines & Healthcare products Regulatory Agency
United Kingdom
TGA
Therapeutic Goods Administration
Australia
Health Canada
Health Canada GMP
Canada
PMDA
Pharmaceuticals & Medical Devices Agency
Japan
EDQM / CEP
European Directorate for the Quality of Medicines
Europe
PIC/S
Pharmaceutical Inspection Co-operation Scheme
International
WHO-GMP
World Health Organization Good Manufacturing Practice
International
WHO-PQ
WHO Prequalification
International

Quality & Safety Management Systems

  • ISO 9001:2015 (Quality Management)
  • ISO 13485:2016 (Medical Devices)
  • ISO 14001 (Environmental Management)
  • ISO 22000 / FSSC 22000 (Food Safety – Nutraceuticals)
  • cGMP (Current Good Manufacturing Practice)
  • GLP (Good Laboratory Practice)
  • HACCP & HALAL Certification
  • Schedule M (India) & ICH Guidelines

Emerging-Market Regulatory Registrations

NAFDAC (Nigeria)SAHPRA (South Africa)TMDA (Tanzania)PPB (Kenya)EFDA (Ethiopia)NDA (Uganda)NMRA (Sri Lanka)DIGEMID (Peru)ANVISA (Brazil)COFEPRIS (Mexico)INVIMA (Colombia)Saudi FDAUAE MOHNMPA (China)MFDS (South Korea)ZAMRA (Zambia)MCAZ (Zimbabwe)MOH Cambodia / Nepal / Yemen

Documentation supported for registration across 50+ countries including COPP, GMP certificates and CTD / ACTD dossiers.

Manufacturing Capabilities

Dosage Forms We Can Manufacture

From simple oral solids to complex sterile injectables, oncology and nutraceuticals — across all major delivery formats.

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Tablets

Immediate & sustained release, enteric-coated, bilayer, effervescent, chewable, dispersible & film-coated.

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Capsules

Hard gelatin, softgels, pellet-filled and liquid-filled capsules.

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Sterile Injectables

Liquid & lyophilized vials, ampoules, pre-filled syringes and dry powder injections.

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IV Fluids & Infusions

Large & small volume parenterals (LVP / SVP) in bottles, bags and vials.

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Liquid Orals

Syrups, suspensions, dry syrups, drops and oral solutions.

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Topicals & Semi-solids

Creams, ointments, gels, lotions and dermatological preparations.

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Ophthalmic & Nasal

Eye / ear / nasal drops, ophthalmic ointments and nasal sprays.

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Oncology & Hormonal

Cytotoxic / high-potency injectables & tablets in dedicated facilities.

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Inhalation

Metered-dose inhalers (MDI), dry powder inhalers (DPI) and respules.

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Sachets & Powders

ORS, oral powders, granules, effervescent sachets and premixes.

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Suppositories & Pessaries

Rectal and vaginal dosage forms for specialist indications.

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Nutraceuticals

Softgels, gummies, protein powders, effervescent tablets & capsules.

How It Works

Our Contract Manufacturing Process

A transparent, step-by-step journey from your first enquiry to finished goods delivered at your port.

01

Enquiry & Product Selection

Share your product, molecule, strength, dosage form, target market and quantity. We recommend the best-fit accredited facility.

02

Quotation & Agreement

Transparent per-unit pricing, MOQ, timelines and a formal contract / loan-license or third-party manufacturing agreement.

03

Formulation & Development

Custom formulation development, sample batches, and stability studies as per ICH zones for your destination climate.

04

Regulatory Dossier & Artwork

Preparation of CTD / ACTD dossiers, product registration documents and your brand artwork, labels and packaging design.

05

Manufacturing

Production at an accredited facility (USFDA / EU-GMP / WHO-GMP class) under your specified branding and packaging.

06

Quality Control & Testing

In-process and finished-product testing in accredited QC laboratories with full batch documentation and retention samples.

07

Packaging & Private Labeling

Blister, strip, bottle, vial and carton packing with your brand, multi-language labeling and market-specific artwork.

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Export, Shipping & Delivery

Complete export documentation, cold-chain where required, and door-to-port / door-to-door delivery to your market.

Regulatory & Documentation Support

Complete Documentation, Handled For You

Successful export and registration depend on flawless paperwork. Our regulatory team prepares and provides every document your market requires, so your products clear customs and registration without delays.

  • Certificate of Pharmaceutical Product (COPP / CoPP)
  • Certificate of Analysis (COA) — batch-wise
  • CTD / ACTD Product Registration Dossiers
  • GMP & WHO-GMP Certificates of the manufacturing site
  • Free Sale Certificate (FSC)
  • Material Safety Data Sheets (MSDS)
  • Stability Study Data (ICH Zones II–IVb)
  • Method of Analysis & Method Validation reports
  • Drug Master File (DMF) support where applicable
  • Product artwork, packing lists & shipping documents
Pharmaceutical regulatory documentation and quality control
Shipping & Logistics

Delivered Anywhere in the World

Reliable global logistics with full export documentation and validated cold-chain where required.

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Complete Export Documentation

Invoice, packing list, COO, COA, COPP, insurance and country-specific import paperwork prepared for you.

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Cold-Chain Logistics

Temperature-controlled and validated shipping for thermolabile and injectable products.

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Air & Sea Freight

Flexible FOB, CIF and CFR terms via trusted freight forwarders to any port worldwide.

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Import Permit Assistance

Guidance on registration, import licenses and destination-country regulatory compliance.

Frequently Asked Questions

Contract Manufacturing FAQs

What is the difference between third-party and contract manufacturing?

Both mean we get your product manufactured for you at an accredited facility. In third-party / loan-license manufacturing you provide the brand and formula and we handle production, packaging and export under your label. Contract manufacturing can also include full formulation development from scratch.

Which accreditations do your manufacturing facilities hold?

Our partner facilities hold accreditations including USFDA, EU-GMP, UK MHRA, TGA (Australia), Health Canada, PMDA (Japan), EDQM, PIC/S, WHO-GMP and WHO Prequalification, along with ISO quality systems. We match the facility to your target market’s regulatory requirement.

What is the minimum order quantity (MOQ)?

MOQ depends on the dosage form and facility. We work with you to arrive at commercially viable batch sizes, including trial batches for new formulations.

Can you handle product registration in my country?

Yes. We prepare CTD / ACTD dossiers, COPP, GMP certificates and all supporting documentation, and assist your local regulatory agent with the registration process.

Will the products carry my brand?

Absolutely. We offer full private labeling — your brand name, artwork, packaging, multi-language labels and market-specific design.

Ready to Manufacture Your Products?

Tell us your product, dosage form, target market and quantity — we'll match you with the right accredited facility and send a detailed quotation.