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Suppliers and packagers for generic pharmaceutical drug: ACETAMINOPHEN
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ACETAMINOPHEN
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Aspiro | ACETAMINOPHEN | acetaminophen | SOLUTION;INTRAVENOUS | 216617 | ANDA | Camber Pharmaceuticals, Inc. | 31722-205-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (31722-205-10) / 100 mL in 1 VIAL, SINGLE-DOSE (31722-205-31) | 2022-07-27 |
| Aspiro | ACETAMINOPHEN | acetaminophen | SOLUTION;INTRAVENOUS | 216617 | ANDA | Camber Pharmaceuticals, Inc. | 31722-205-24 | 24 VIAL, SINGLE-DOSE in 1 CARTON (31722-205-24) / 100 mL in 1 VIAL, SINGLE-DOSE (31722-205-31) | 2022-07-27 |
| B Braun Medical | ACETAMINOPHEN | acetaminophen | SOLUTION;INTRAVENOUS | 204957 | NDA | B. Braun Medical Inc. | 0264-4050-80 | 24 CONTAINER in 1 CASE (0264-4050-80) / 50 mL in 1 CONTAINER | 2021-02-18 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for generic pharmaceutical drug: ACETAMINOPHEN
Who Supplies Acetaminophen to the Pharmaceutical Market?
Acetaminophen (paracetamol) is a high-volume, commodity Active Pharmaceutical Ingredient (API) with a deep global supply base. Supplier qualification typically splits into two lanes: (1) API manufacturers of record for acetaminophen (API) and (2) finished-dose manufacturers that package acetaminophen tablets, capsules, and combination products under branded or private-label programs.
Which companies manufacture acetaminophen API?
Below are established, widely cited API and bulk-drug producers that have published acetaminophen capabilities and supply into global pharmaceutical markets.
Global API and bulk-drug manufacturers (representative)
| Company | HQ / Region (public) | Typical role in market | Product form commonly supplied |
|---|---|---|---|
| Jiangsu Hengrui Medicine (Hengrui) | China | API and pharmaceutical intermediate supply | Acetaminophen API (paracetamol) (supplier presence in China bulk market) |
| Shandong Lukang Pharmaceutical | China | API manufacturing | Acetaminophen API (paracetamol) |
| Ningbo Sansheng Pharmaceutical | China | API manufacturing | Acetaminophen API |
| Nantong Jiuzhou Pharmaceutical | China | API supply | Acetaminophen API |
| Hangzhou Keyun Pharmaceutical | China | API supply | Acetaminophen API |
| Hubei Jinghong Pharmaceutical | China | API supply | Acetaminophen API |
| Sudeep Pharma Chem | India | API manufacturing | Acetaminophen API |
| Borregaard (downstream only; not an acetaminophen API producer) | Europe | Not relevant for acetaminophen | Not a direct acetaminophen supplier (listed only to avoid misattribution) |
Source basis: acetaminophen API supplier listings are routinely published via chemical and API distributor databases and industry supplier directories that aggregate vendor capabilities for procurement and qualification workflows (example sources cited below). [1]-[3]
Which finished-dose manufacturers supply acetaminophen tablets and capsules?
Acetaminophen finished-dose production is split across brand owners, large global generic firms, and contract manufacturers (CMOs) that fill-and-finish for private label.
Representative finished-dose and generic manufacturers (representative)
| Company | Common packaging footprint | Typical role | Drug form |
|---|---|---|---|
| Teva | U.S. and global | Generic and branded alternatives | Tablets, capsules |
| Lupin | U.S. and global | Generic | Tablets, combination products |
| Sandoz | Global | Generic | Tablets, caplets |
| Mylan (Viatris) | Global | Generic | Tablets, extended supply cycles |
| Dr. Reddy’s | Global | Generic | Tablets, combination products |
| Amneal | U.S. | Generic | Tablets, capsules |
Source basis: manufacturer participation in acetaminophen dosage forms is visible through drug product label coverage and generic product presence in public drug databases. [4]-[6]
How do procurement teams validate acetaminophen suppliers?
Qualification centers on regulatory compliance and manufacturing documentation, not marketing claims. For acetaminophen, procurement workflows typically enforce these controls:
Quality documentation that drives supplier acceptance
- GMP compliance: Evidence that API and/or finished-dose manufacturing is under current Good Manufacturing Practice (cGMP).
- Regulatory filings: Batch- and site-specific information that supports commercial supply.
- Third-party audits: Qualification packages and audit outcomes aligned to risk.
Regulatory and listing checkpoints
- FDA drug product and label databases for finished-dose products and distributor attribution. [4]
- FDA drug establishment and manufacturing site records (where available) for site-level inspection and compliance history. [7]
- API supplier listings through public industry aggregators used in early-stage vendor screening and RFP response routing. [1]-[3]
What supplier categories matter most for acetaminophen procurement?
Acetaminophen sourcing is usually managed through one of these procurement structures:
1) Direct API procurement
Used when a company manufactures its own finished dose or operates a contract fill strategy with API supplied by the client.
2) Finished-dose contract supply
Used when the company owns the packaging/labeling strategy but delegates manufacturing to a contract manufacturer.
3) Private-label programs
Used when volume is high and commercial launch timing is short. Supplier selection is driven by packaging line readiness and regulatory dossier strength.
Supplier landscape patterns specific to acetaminophen
Concentration in Asia for API
The acetaminophen API supply base is heavily represented by China- and India-based manufacturers, with multiple producers competing on cost, batch reliability, and dossier acceptance.
Multiple supplier qualification is standard
Acetaminophen’s high sales volume and supply exposure commonly lead to multi-sourcing to reduce risk from single-site disruptions.
Key Takeaways
- Acetaminophen is a commodity API with a broad supplier base; procurement usually sources through China and India API manufacturers and pairs API supply with either in-house finishing or contract fill-and-finish.
- Supplier selection should be anchored to GMP status, site-level regulatory records, and product dossier traceability, not directory presence alone.
- Finished-dose supply is served by large generics manufacturers and contract manufacturing networks, with product label databases and regulatory listings used to map real-world sourcing footprints.
FAQs
1) Is acetaminophen (paracetamol) sourced mostly as an API or as finished tablets?
Both. High-volume brands and generics frequently procure API directly and manufacture tablets/caplets, while private-label programs often procure finished-dose from contract manufacturers.
2) What regions dominate acetaminophen API manufacturing?
Asia dominates, with multiple China- and India-based manufacturers supplying acetaminophen API into global markets. [1]-[3]
3) How do buyers verify an acetaminophen supplier’s GMP standing?
Through cGMP documentation tied to the specific manufacturing site, supported by regulatory inspection records where available, and audit results for dossier acceptance. [7]
4) Are there many suppliers for acetaminophen versus niche APIs?
Yes. Acetaminophen’s market depth creates a large vendor set, enabling multi-sourcing strategies for supply continuity.
5) What sources are most useful for mapping actual acetaminophen product supply?
FDA label and product databases for finished-dose footprints, and industry supplier directories for initial API vendor screening. [4]-[6]
References (APA)
[1] ChemBK. (n.d.). Acetaminophen manufacturers, suppliers, exporters, wholesalers. Retrieved April 26, 2026, from https://www.chembk.com/
[2] ChemicalBook. (n.d.). Acetaminophen suppliers. Retrieved April 26, 2026, from https://www.chemicalbook.com/
[3] Alibaba. (n.d.). Acetaminophen (paracetamol) API suppliers. Retrieved April 26, 2026, from https://www.alibaba.com/
[4] U.S. Food and Drug Administration. (n.d.). Drugs@FDA. Retrieved April 26, 2026, from https://www.accessdata.fda.gov/scripts/cder/daf/
[5] U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved April 26, 2026, from https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
[6] U.S. National Library of Medicine. (n.d.). DailyMed. Retrieved April 26, 2026, from https://dailymed.nlm.nih.gov/dailymed/
[7] U.S. Food and Drug Administration. (n.d.). OpenFDA Drug Establishments (where available) and related public inspection and establishment information. Retrieved April 26, 2026, from https://open.fda.gov/
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