Last Updated: May 1, 2026

Suppliers and packagers for generic pharmaceutical drug: IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE


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IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Haleon Us Holdings ADVIL COLD AND SINUS ibuprofen; pseudoephedrine hydrochloride CAPSULE;ORAL 021374 NDA Haleon US Holdings LLC 0573-0184-16 16 BLISTER PACK in 1 CARTON (0573-0184-16) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2002-05-30
Haleon Us Holdings ADVIL COLD AND SINUS ibuprofen; pseudoephedrine hydrochloride CAPSULE;ORAL 021374 NDA Haleon US Holdings LLC 0573-0184-32 32 BLISTER PACK in 1 CARTON (0573-0184-32) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2002-05-30
Aurobindo Pharma IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE ibuprofen; pseudoephedrine hydrochloride CAPSULE;ORAL 209235 ANDA WALGREEN CO. 0363-1106-08 4 BLISTER PACK in 1 CARTON (0363-1106-08) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2017-12-01
Aurobindo Pharma IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE ibuprofen; pseudoephedrine hydrochloride CAPSULE;ORAL 209235 ANDA WALGREEN CO. 0363-1106-67 2 BLISTER PACK in 1 CARTON (0363-1106-67) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2017-12-01
Aurobindo Pharma IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE ibuprofen; pseudoephedrine hydrochloride CAPSULE;ORAL 209235 ANDA Amerisource Bergen 46122-609-58 4 BLISTER PACK in 1 CARTON (46122-609-58) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2017-12-01
Aurobindo Pharma IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE ibuprofen; pseudoephedrine hydrochloride CAPSULE;ORAL 209235 ANDA Aurohealth LLC 58602-803-03 1 BLISTER PACK in 1 CARTON (58602-803-03) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (58602-803-83) 2017-12-01
Aurobindo Pharma IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE ibuprofen; pseudoephedrine hydrochloride CAPSULE;ORAL 209235 ANDA Aurohealth LLC 58602-803-08 4 BLISTER PACK in 1 CARTON (58602-803-08) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (58602-803-83) 2017-12-01
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Suppliers and packagers for generic pharmaceutical drug: IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

Last updated: April 24, 2026

What Suppliers Commonly Supply Ibuprofen and Pseudoephedrine Hydrochloride?

Which companies supply ibuprofen (API and/or intermediates)?

Ibuprofen is a high-volume, commodity NSAID API with multiple global supply sources across China, India, and Europe. Typical supplier categories include API manufacturers, intermediate suppliers, and toll manufacturers.

Representative global supplier set (API and related industrial supply):

  • Hangzhou First Applied Material Technology / Zhejiang-type ibuprofen API supply ecosystem (China-based bulk chemical supply)
  • Sichuan Tongsheng / Sichuan-based fine chemical supply ecosystem (China-based bulk ibuprofen API supply)
  • BASF (generic pharma chemicals and downstream integration; some routes via fine-chemical suppliers)
  • Synthon (EU-based API manufacturing capability for NSAIDs; product mix depends on grade)
  • Aurobindo Pharma (India-based API capacity; ibuprofen product availability varies by grade)
  • Torrent Pharmaceuticals / Torrent Intermediates supply chain (India-based capacity for standard APIs and intermediates)
  • Cipla (API and intermediates via group manufacturing; ibuprofen availability varies)

How to validate an actual supplier match (business checklist):

  • Confirm API form (ibuprofen, not salts), grade (USP/EP/FCC), impurity specs, and DMF/CEP status if required by target markets.
  • Confirm whether the supplier provides direct API or key intermediates (e.g., chlorination/esterification steps in ibuprofen synthesis) based on your route.

Which companies supply pseudoephedrine hydrochloride (API and controlled supply chains)?

Pseudoephedrine hydrochloride is a regulated precursor linked to methamphetamine and other illicit synthesis routes. Supply is typically tighter, more compliance-driven, and often delivered through licensed channels.

Representative global supplier set (API and precursor supply):

  • Merck (regulated chemical supply via established pharma/chem distribution; availability depends on jurisdiction and compliance status)
  • BASF (regulated chemicals supply chain)
  • Tianjin-type and Jiangsu/Zhejiang-type licensed chemical manufacturers (China-based precursor API supply is common, but production and export depend on regulatory approvals)
  • Indian regulated precursor manufacturers (India-based API/precursor supply via licensed entities; exports depend on destination paperwork)
  • EU licensed chemical distributors/manufacturers (pseudoephedrine is not a normal open-market commodity)

Operational note for procurement: In most jurisdictions, pseudoephedrine hydrochloride supply depends on:

  • Customer licensing (import/export, sales authorization)
  • End-use statements
  • Country-specific quota or permit systems
  • Shipment-by-shipment compliance checks

How supply differs by product type (ibuprofen vs pseudoephedrine HCl)

Attribute Ibuprofen Pseudoephedrine hydrochloride
Market structure Commodity-like API with many global manufacturers Regulated precursor supply with licensed operators and tighter distribution
Qualification cycle Shorter in many cases if specs align Longer due to compliance screening and documentation
Typical procurement risk Price volatility in commodity inputs; quality/impurity alignment Regulatory delays, permit requirements, and customer licensing constraints
Competitive landscape Many API producers and intermediate suppliers Fewer compliant suppliers per jurisdiction; route and documentation matter

Supplier selection criteria that govern successful sourcing

Use the same scoring model across both molecules:

API quality and regulatory alignment

  • Target grade: USP/EP/JP where applicable
  • Batch release approach: COA traceability and impurity profile controls
  • Stability data and packaging integrity documentation

Compliance and logistics (especially pseudoephedrine HCl)

  • Confirmation of licensed manufacturing and export rights
  • Ability to provide end-use documentation support
  • Cold-chain is not typically the issue, but controlled substance handling is

Commercial execution

  • Lead time by route (API vs intermediate-to-API conversions)
  • MOQ and price ladder by annual volume
  • Contract manufacturing option (tolling) where direct API supply is constrained

Procurement-ready supplier mapping (what to assign internally)

To move from a “supplier list” to actionable procurement:

  1. Ibuprofen: shortlist API manufacturers and large fine-chemical suppliers that already sell to pharma customers in your target markets.
  2. Pseudoephedrine HCl: shortlist licensed precursor manufacturers and distributors with documented regulatory workflows for your destination country.

Key Takeaways

  • Ibuprofen is a high-volume API with broad global supply; qualification focus is primarily on spec alignment and impurity control.
  • Pseudoephedrine hydrochloride is a regulated precursor; sourcing depends on licensed manufacture/export, customer authorization, and end-use documentation.
  • Supplier evaluation should be spec-first for ibuprofen and compliance-first for pseudoephedrine HCl, then converge on quality and logistics.

FAQs

  1. Can I source ibuprofen and pseudoephedrine hydrochloride from the same supplier?
    Sometimes, but pseudoephedrine HCl typically requires dedicated licensed precursor supply chains. Many “general pharma chemical” suppliers do not hold the necessary precursor permissions for all lanes.

  2. What documentation matters most for pseudoephedrine hydrochloride procurement?
    Customer licensing, end-use declarations, and shipment-by-shipment compliance records for the destination jurisdiction.

  3. Is ibuprofen usually supplied as an API or as a finished tablet ingredient?
    For R&D and manufacturing, it is typically sourced as API or as standardized intermediates depending on route and regulatory needs.

  4. Do suppliers provide pseudoephedrine hydrochloride in multiple grades?
    Yes, but the practical availability is tightly tied to regulatory status, customer eligibility, and destination-market requirements.

  5. How do lead times usually differ between the two products?
    Ibuprofen lead times are often more predictable; pseudoephedrine HCl lead times can extend due to permitting, quotas, and compliance clearance.


References (APA)

[1] Merck. (n.d.). Chemical and pharmaceutical ingredients supply information. https://www.merckgroup.com
[2] BASF. (n.d.). Chemicals and regulated supply chain information. https://www.basf.com
[3] U.S. Drug Enforcement Administration. (n.d.). Diversion control and regulated chemicals (precursor context for pseudoephedrine). https://www.dea.gov

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