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Suppliers and packagers for PRAVASTATIN SODIUM
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PRAVASTATIN SODIUM
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 | PRAVASTATIN SODIUM | pravastatin sodium | TABLET;ORAL | 207068 | ANDA | Accord Healthcare Inc. | 16729-008-15 | 90 TABLET in 1 BOTTLE (16729-008-15) | 2017-02-16 |
| Accord Hlthcare | PRAVASTATIN SODIUM | pravastatin sodium | TABLET;ORAL | 207068 | ANDA | Accord Healthcare Inc. | 16729-008-16 | 500 TABLET in 1 BOTTLE (16729-008-16) | 2017-02-16 |
| Accord Hlthcare | PRAVASTATIN SODIUM | pravastatin sodium | TABLET;ORAL | 207068 | ANDA | Accord Healthcare Inc. | 16729-009-15 | 90 TABLET in 1 BOTTLE (16729-009-15) | 2017-02-16 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for PRAVASTATIN SODIUM
Who supplies pravastatin sodium (API and intermediates) to pharma manufacturers?
Pravastatin sodium supply typically comes from (1) API manufacturers producing “pravastatin sodium” or “pravastatin” and converting to the sodium salt at the end of synthesis, and (2) intermediate suppliers supplying late-stage precursors used to complete API synthesis. The commercial supply chain is dominated by companies with chemical fermentation/statin expertise and established DMF/CEP dossiers.
What are the main categories of suppliers?
- API manufacturers (pravastatin sodium or pravastatin → sodium salt conversion)
- Contract and commercial suppliers that sell pravastatin sodium API into global markets under DMF/CEP-supported dossiers.
- Specialty chemical and intermediate suppliers
- Firms supplying key statin intermediates and building blocks used to complete pravastatin synthesis and salt formation.
- Formulation and finished-dose upstream suppliers
- Not “API suppliers” in the strict sense, but they can integrate backward supply for internal manufacturing of tablets that contain pravastatin sodium.
Which companies are known suppliers of pravastatin sodium API?
The following supplier set covers the major players that have historically held pravastatin supply contracts and/or API approvals across major jurisdictions and tenders. These names also show up repeatedly across API catalogues and regulatory filings for statins.
| Supplier | Supplier type | Typical offering | Notes for sourcing diligence |
|---|---|---|---|
| Jiangsu Hengrui Medicine (China) | API manufacturer | Pravastatin sodium API | China-based statin producer; commonly listed in global API supply catalogues. |
| Zydus Lifesciences (India) | API manufacturer | Pravastatin sodium API | India-based API supplier with broad portfolio and regulated exports. |
| Hetero Drugs (India) | API/solid dose ecosystem | Pravastatin sodium API | Large India pharma group; supplies multiple statin actives to branded and generic channels. |
| Sun Pharma / Sun Pharma Advanced Research (India) | API ecosystem | Statins including pravastatin | Often supplies via group entities and partner networks. |
| Torrent Pharmaceuticals (India) | API/finished dose ecosystem | Statin products and actives | India-based group with generics and manufacturing footprint relevant to statins. |
| Sandoz (Novartis) (Europe/global) | Branded/generic pharma supply | Pravastatin sodium finished dose, sometimes via API network | Finished-dose presence often implies established upstream API sourcing. |
| Teva (Israel/Europe/global) | Generic pharma supply | Pravastatin sodium finished dose, API sourced through approved vendors | Often uses supplier qualification programs for API. |
| Mylan / Viatris (US/global legacy) | Generic pharma supply | Pravastatin sodium finished dose, API network | Supply chain uses qualified API vendors. |
Business implication: if you need pravastatin sodium API at scale with consistent regulatory support, API manufacturers in China and India dominate sourcing options. Finished-dose companies often qualify multiple API sources to de-risk compliance and continuity.
How do you vet a pravastatin sodium supplier for regulatory-grade supply?
What documentation should be required before placing supply orders?
For pharma-grade pravastatin sodium API, buyers typically qualify suppliers using the following evidence set:
| Qualification item | What to require | Why it matters in practice |
|---|---|---|
| Regulatory dossier support | DMF or equivalent submissions, and evidence of approval status in target markets | Establishes legal market access path. |
| Manufacturing site compliance | GMP inspection history (FDA, EMA, MHRA, local authorities), latest inspection outcomes | Reduces risk of batch rejection or approval delay. |
| Analytical specification package | Complete API specs, test methods, and validation summary | Prevents re-test cycles and reduces inbound QC escalation. |
| CoA for commercial batches | Third-party tested CoA with impurity profile and assay | Confirms real-world batch consistency. |
| Stability data | Real-time and accelerated stability under proposed storage | Impacts retest date and shelf-life claims. |
| Quality agreements | Change control, deviation handling, OOS/OOT, and audit rights | Sets governance for continuous compliance. |
Business implication: for generics and branded manufacturers, the supplier qualification standard is less about catalogue claims and more about dossier-linked chemistry and batch-level impurity control.
What are the main supply constraints for pravastatin sodium?
Where do supply bottlenecks usually occur?
- Late-stage chemistry and impurity control
- Pravastatin impurity profile is sensitive to process parameters, solvents, and salt conversion.
- Salt conversion and final hold times
- Converting “pravastatin” to “pravastatin sodium” adds an additional unit operation with potential variability.
- Regulatory site concentration
- A smaller number of API sites can maintain consistent global compliance, especially for statins.
Business implication: successful procurement often depends on whether the supplier has validated sodium salt conversion and can consistently hit impurity limits tied to your application (ANDA/MAA/market authorization).
What pricing and lead-time patterns should you expect?
How do lead times and price structure usually behave?
- Lead times: commonly driven by fermentation or chemical intermediate production scheduling, plus salt conversion and release testing. Contract lead times can stretch when suppliers run fermentation cycles or when multiple customers demand the same impurity-controlled intermediates.
- Price structure: usually tied to (1) raw materials for the key statin scaffold, (2) solvent and salt conversion costs, and (3) QA and stability testing overhead due to regulatory expectations.
Business implication: multi-source qualification reduces price spikes and mitigates delays tied to site-level capacity or batch release constraints.
How should procurement structure multi-vendor supply for continuity?
What sourcing strategy reduces operational risk?
A typical low-friction approach for pravastatin sodium continuity is:
- Qualify two API suppliers with independent manufacturing sites.
- Tie qualification to dossier-linked specs (assay, impurities, residual solvents, water content, and salt form).
- Lock stability and re-test dates in the purchase order terms to avoid inbound reshipments.
- Use batch-to-batch impurity trend monitoring on early lots to confirm process control.
Key Takeaways
- Pravastatin sodium supply is concentrated in a relatively small set of API manufacturers, with China and India leading commercial volume options.
- Supplier qualification should prioritize dossier support (DMF/CEP), GMP inspection outcomes, validated analytical methods, and batch CoA consistency with sodium salt conversion.
- The practical bottlenecks typically sit in late-stage chemistry, impurity control, and the sodium salt conversion step.
- Procurement continuity is best achieved through dual-sourcing tied to application-specific specifications and stability/re-test date terms.
FAQs
1) Can a supplier sell “pravastatin” instead of “pravastatin sodium”?
Yes. Many suppliers sell “pravastatin” API and perform salt conversion to pravastatin sodium as part of the final step, but you must qualify the resulting salt form against your specs.
2) Which supplier types are best for regulated pravastatin sodium API?
API manufacturers with established statin chemistry and regulatory dossier support are the most direct fit for commercial API sourcing.
3) What are the most critical quality attributes for pravastatin sodium API?
Assay, impurity profile, residual solvents, water content, and confirmed salt form (sodium salt) backed by validated methods and batch CoAs.
4) What documents matter most during supplier onboarding?
DMF or dossier support status, GMP evidence for the specific manufacturing site, validated specifications and test methods, and stability data tied to the intended storage and retest periods.
5) Why do pravastatin sodium supply contracts sometimes face schedule changes?
Process steps that govern impurity control and the sodium salt conversion unit operation can constrain capacity and batch release timing.
References
[1] FDA Drug Master Files (DMF) database. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/dmf/
[2] European Medicines Agency (EMA). CEP and certificates information (where applicable). https://www.ema.europa.eu/en/human-regulatory/overview/quality
[3] EudraGMDP database (GMP inspections and manufacturing authorizations, where accessible). European Medicines Agency. https://www.eudragmdp.ema.europa.eu/
[4] International Council for Harmonisation (ICH) guidelines on specifications and stability principles (for qualification alignment). https://www.ich.org/
[5] United States Pharmacopeia (USP) monographs and general chapters relevant to statin API testing principles. https://www.usp.org/
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