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Suppliers and packagers for generic pharmaceutical drug: HYDROXYCHLOROQUINE SULFATE
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HYDROXYCHLOROQUINE SULFATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Accord Hlthcare | HYDROXYCHLOROQUINE SULFATE | hydroxychloroquine sulfate | TABLET;ORAL | 213342 | ANDA | Accord Healthcare, Inc., | 16729-485-01 | 100 TABLET in 1 BOTTLE (16729-485-01) | 2020-05-12 |
| Accord Hlthcare | HYDROXYCHLOROQUINE SULFATE | hydroxychloroquine sulfate | TABLET;ORAL | 213342 | ANDA | Accord Healthcare, Inc., | 16729-485-16 | 500 TABLET in 1 BOTTLE (16729-485-16) | 2020-05-12 |
| Accord Hlthcare | HYDROXYCHLOROQUINE SULFATE | hydroxychloroquine sulfate | TABLET;ORAL | 213342 | ANDA | Accord Healthcare, Inc., | 16729-561-01 | 100 TABLET in 1 BOTTLE (16729-561-01) | 2021-09-28 |
| Accord Hlthcare | HYDROXYCHLOROQUINE SULFATE | hydroxychloroquine sulfate | TABLET;ORAL | 213342 | ANDA | Accord Healthcare, Inc., | 16729-562-01 | 100 TABLET in 1 BOTTLE (16729-562-01) | 2021-09-28 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for generic pharmaceutical drug: HYDROXYCHLOROQUINE SULFATE
Who Supplies Hydroxychloroquine Sulfate to the Pharma Market?
Hydroxychloroquine sulfate is a generic active pharmaceutical ingredient (API) with a multi-supplier, global supply chain. The market standard is to source either (1) hydroxychloroquine sulfate API for drug manufacturers or (2) finished dosage forms from qualified manufacturers for brand and generic products. Publicly available supplier lists are fragmented by region and qualification status, but the supplier landscape is consistently dominated by API manufacturers in India and China, with additional sourcing via toll manufacturers and contract development and manufacturing organizations (CDMOs) that supply finished tablets.
Which Companies Supply Hydroxychloroquine Sulfate (API) for Pharma?
The following companies are repeatedly identified in public regulatory and commercial records as manufacturers and/or distributors of hydroxychloroquine sulfate (API) or hydroxychloroquine-based materials used in pharmaceutical products.
India-based API and drug substance supply
| Supplier | Likely role in supply chain | Public sourcing indicators |
|---|---|---|
| Hetero Labs / Hetero Drugs (Hetero group) | API and/or finished formulations | Multiple product and substance footprints across generic antimalarials; Indian supply presence in global filings (company group commonly appears as manufacturer for hydroxychloroquine products). |
| Zydus Lifesciences / Zydus | API and/or finished products | Broad API and formulation manufacturing footprint in generic specialty and anti-infectives; recurrent presence in global generic supply chains. |
| Cipla | Finished products and potentially supply of intermediates/API for its own generics | Large-scale generic supply chain for hydroxychloroquine products during demand spikes; established internal and external sourcing networks. |
| Sun Pharma | Finished products and API supply chain | Antimalarial portfolio and global generic supply footprint. |
China-based API and drug substance supply
| Supplier | Likely role in supply chain | Public sourcing indicators |
|---|---|---|
| Wuhan Humanwell / Humanwell Pharmaceutical | API and/or finished supply | Humanwell is a known antimalarial manufacturer with documented global product footprint. |
| Shanghai Fosun Pharmaceutical (and related supply entities) | API and/or finished supply | Antimalarial-related manufacturing networks tied to Fosun generic business. |
| Chongqing Zhengtian / other large Chinese API manufacturers | API | API manufacturing clusters in China regularly supply hydroxychloroquine sulfate into global generic channels (China’s API base is a common origin for hydroxychloroquine sulfate supply). |
European and US-linked distributors (supply channel)
| Supplier | Likely role in supply chain | Public sourcing indicators |
|---|---|---|
| McKesson (distribution channel) | Distribution of finished drug and/or sourcing intermediates | US distribution presence for generic drug supply during demand fluctuations. |
| AmerisourceBergen (distribution channel) | Distribution | Large US distributor; commonly listed across generic drug sourcing during shortages. |
How Do Pharma Buyers Verify Qualified Supply for Hydroxychloroquine Sulfate?
Buyers typically qualify hydroxychloroquine sulfate suppliers by combining regulatory, documentation, and quality-system requirements. The most defensible qualification pathway uses ANDA or DMF-linked sourcing where applicable, plus GMP documentation from the supplier.
Qualification gates used in practice
- Regulatory evidence for API manufacture: US DMF/AMP referencing when available in filings; EU and national authority manufacturing authorizations for the specific manufacturing site.
- GMP compliance: current GMP status, site audit record, and quality agreement coverage for the specific API manufacturer and grade.
- Chemical quality requirements: specification for identity, assay, impurities, residual solvents (as applicable), and polymorph/particle characteristics where relevant.
- Supply reliability: confirmed supply capacity, lead time, batch release time, and ability to support change notifications.
What Specifications Do Hydroxychloroquine Sulfate Suppliers Typically Support?
Hydroxychloroquine sulfate is a defined API with pharmacopoeial anchors. Suppliers support typical pharmacopoeial-aligned specifications and documentation for batch release.
Common reference points
| Specification element | Typical basis used by pharma buyers |
|---|---|
| Identity and assay | Pharmacopoeial monograph (for example, BP/USP-aligned specs) |
| Impurity profile | Pharmacopoeial and internal validated thresholds |
| Form and salt confirmation | Hydroxychloroquine sulfate salt form confirmation and consistent characterization |
| Stability and storage | Temperature and humidity conditions per approved labeling/specs |
Which Documents Matter Most to Procurement?
Procurement teams generally require the supplier dossier for hydroxychloroquine sulfate through a standardized documentation set used by API buyers.
Core documentation
- CoA (certificate of analysis) for each batch
- DMF/AMP references where the supplier’s site is referenced to support approved manufacturing
- GMP certificate for the specific API manufacturing site
- Quality agreement (QA roles, deviations, change control, audit rights)
- Stability data tied to the supplier’s claimed shelf life
Supply Chain Reality: What Drives Supplier Selection?
Hydroxychloroquine sulfate supply is influenced by the same levers that govern most generic APIs: manufacturing capacity, the number of qualified sites, import approvals, and contract coverage.
Decision drivers for buyers
| Driver | Impact on sourcing |
|---|---|
| Qualification status (site-specific) | Determines whether a supplier can be used in approved product manufacturing |
| Capacity and raw material availability | Controls lead time and continuity of supply |
| Regulatory traceability | Determines whether the supplier can be used without triggering product filing risk |
| Batch release performance | Impacts production scheduling and inventory |
| Price volatility | Tends to spike during public health demand surges and then normalizes |
Where Do Buyers Commonly Find Multiple Supply Options?
Hydroxychloroquine sulfate sourcing is frequently diversified across:
- Multiple API manufacturing sites in India and China
- Secondary sourcing through distributors for rapid procurement and contingency inventory
- CDMOs that provide finished tablets when product demand drives speed over direct API procurement
Key Takeaways
- Hydroxychloroquine sulfate is a generic API supplied primarily through multi-site manufacturers in India and China, with additional distribution and finished product supply from large global generic players.
- Buyer qualification depends on site-specific regulatory evidence, GMP, and batch documentation (CoA, CoC, stability, and change control).
- In practice, procurement builds resilience by using multiple qualified suppliers and distribution backups to control lead time and batch-release continuity.
FAQs
1) Is hydroxychloroquine sulfate supplied as API or finished tablets?
Yes. Buyers commonly source either the API for their own manufacturing or finished tablets via generic manufacturers/CDMOs.
2) Which regions dominate hydroxychloroquine sulfate API supply?
The API supply base is dominated by manufacturing clusters in India and China, with additional distribution roles in the US/EU.
3) How do procurement teams qualify an API supplier for hydroxychloroquine sulfate?
They qualify based on site-specific GMP, regulatory references (DMF/AMP or equivalent), and review of CoA/quality agreements tied to batch release and change control.
4) Can a distributor be used as a supplier for hydroxychloroquine sulfate?
Distributors can support sourcing and logistics, but product manufacturers still require traceable documentation and responsibility clarity under the quality agreement, including GMP and batch release.
5) What documents are required for hydroxychloroquine sulfate API batches?
Typical requirements include CoA, GMP certificate for the API site, and a complete batch pack covering specifications, analytical methods, and release records.
References
[1] US FDA. “Drug Master Files (DMFs).” FDA website. https://www.fda.gov/drugs/drug-master-files-dmfs
[2] European Medicines Agency. “Manufacturing authorisation and GMP.” EMA website. https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/good-manufacturing-practice
[3] US FDA. “Current Good Manufacturing Practice (CGMP) Regulations.” FDA website. https://www.fda.gov/drugs/pharmaceutical-quality-resources/cgmp-regulations-pharmaceuticals
[4] United States Pharmacopeia (USP). USP monographs and specifications framework. https://www.uspnf.com/monographs
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