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Paracetamol + Codeine tablets bulk supplier for pharma manufacturers

Paracetamol + Codeine Tablets Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 300 mg paracetamol + 30 mg codeine; 300 mg + 60 mg

Reference Brands: Tylenol with Codeine(US)

Category: Analgesic

Paracetamol + Codeine combine analgesic effects, with codeine activating mu-opioid receptors to block pain signals and paracetamol reducing prostaglandin synthesis for pain and fever relief. Benefits include effective moderate pain control, rapid onset, and improved comfort. Caution is needed due to dependence risk and strict regulations.

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Product Description:

Paracetamol + Codeine tablets are approved in the EU and US for moderate pain relief. In the US, brands like Tylenol with Codeine are regulated by the DEA as Schedule II controlled substances, supported by dossiers demonstrating safety, efficacy, and manufacturing standards. In the EU, regulations vary by country, with strict control measures for codeine-containing products. Both regions require detailed dossiers, clinical data, and pharmacovigilance plans for initial approval and ongoing safety. To ensure compliance, navigate complex regulations, and facilitate market access, visit PharmaTradz. We support seamless registration and compliance for paracetamol + codeine formulations, ensuring adherence to European and American standards for safe, effective pain management.

Paracetamol + Codeine Tablets — third party manufacturing & bulk supply

Paracetamol + Codeine Tablets is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.
Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.
Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

Indicative minimum order quantity

Paracetamol + Codeine Tablets is supplied as Tablets — an oral solid dosage form, so the indicative MOQ is 200,000 units. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and shelf life.

Manufacturers of Paracetamol + Codeine Tablets listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.

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Frequently Asked Questions

Paracetamol + codeine is used to relieve mild to moderate pain that cannot be managed by paracetamol alone. It is commonly prescribed for headaches, dental pain, musculoskeletal pain, and other acute pain conditions.

This combination contains paracetamol, a non-opioid analgesic and antipyretic, and codeine phosphate, an opioid analgesic. Paracetamol reduces pain and fever by inhibiting prostaglandin synthesis in the central nervous system, while codeine acts on opioid receptors to enhance pain relief.

Common trade names include Tylenol with Codeine, Panadeine, Codipar, and Solpadeine, depending on the country.

It is manufactured by several pharmaceutical companies including Johnson & Johnson, GlaxoSmithKline, and Sanofi, among others.

The generic name is paracetamol (acetaminophen) and codeine phosphate combination.

Brand names include Tylenol with Codeine, Panadeine, Codipar, and Solpadeine, depending on regional availability.

It is manufactured in multiple regions including the USA, Europe, and Asia, with availability depending on local regulations.

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