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Tofacitinib citrate api suppliers in india?

See the DrugPatentWatch profile for Tofacitinib

Are there tofacitinib citrate API suppliers in India?

I can’t reliably name specific Indian companies as tofacitinib citrate API suppliers from the information provided here. Supplier availability can also change due to regulatory status, customer qualification, and batch-by-batch approvals.

How to find legitimate Indian API suppliers for tofacitinib citrate

To locate credible India-based suppliers, use these practical checks:
- Look for Indian manufacturers or distributors that explicitly list “tofacitinib citrate” (not just “tofacitinib” tablets or intermediates) and provide a clear API grade and dossier details.
- Verify regulatory standing by checking whether they are registered with relevant authorities (for example, if they supply into regulated markets, they typically maintain documentation required for drug-device/medicine supply chain compliance).
- Request documentation before placing an order, such as a CoA (certificate of analysis) for the specific lot, specification sheet, impurity profile, and, where available, DMF/EDMF or equivalent regulatory filings.

What documents you should request from any supplier

For API sourcing, buyers commonly request:
- CoA for the exact batch/lot and test method references
- API specification and typical test results (assay, water content, impurities)
- Manufacturing site information and quality agreements (GMP/GxP compliance evidence)
- Stability/expiry data and recommended storage
- Product intended use clarification (research vs. commercial pharmaceutical supply)

Risks to avoid when sourcing tofacitinib citrate API

Tofacitinib is a regulated active ingredient, and sourcing risk increases if a supplier only provides marketing claims:
- Avoid suppliers that cannot share lot-specific CoA or impurity/safety documentation
- Be cautious with “API” listings that actually refer to intermediates or analytical reference standards
- Confirm export/import compliance for the finished pharmaceutical market you operate in

If you share your sourcing context, I can narrow the search

If you tell me:
- whether you need API for research, compounding, or commercial pharma manufacturing,
- your target market (India domestic, EU, US, etc.),
- the desired grade (pharma vs. analytical reference),
- and your approximate annual quantity,
I can suggest the most appropriate supplier-search approach and what to ask each candidate to confirm fit.



Other Questions About Tofacitinib :

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AI-Drug Label Prescribing Information Alignment Report

78
78%
Grade B

Good

Mostly Aligned

Patient Risk: Low

Summary

The provided AI response themes (serious infections, mortality, malignancy, MACE, thrombosis) are supported by the cited label sections. However, at least one dose/indication restriction statement is only partially supported because the evidence anchoring does not clearly reference the label’s explicit dosing/usage limitation section(s).


Category Scores

Dosage
74
Good
Warnings
88
Good

Accurate Statements

Serious infections may occur; avoid/interrupt tofacitinib if a serious infection develops.
Supported by Warnings and Precautions (5.1) and Administration Instructions (2.2), including instruction to interrupt if a serious/opportunistic infection or sepsis develops.
Increased risk of mortality may occur.
Supported by Warnings and Precautions (5.2).
Malignancy/lymphoproliferative disorders may occur; consider benefits/risks particularly in patients with known malignancy (other than successfully treated NMSC) or current/past smokers.
Supported by Warnings and Precautions (5.3), including the specific qualifier 'other than successfully treated NMSC' and 'current or past smokers.'
Major adverse cardiovascular events (MACE) may occur; discontinue in patients who have experienced MI or stroke.
Supported by Warnings and Precautions (5.4), including discontinuation instruction for MI or stroke.
Thrombosis may occur (including PE, DVT, arterial thrombosis); evaluate promptly and discontinue if symptoms of thrombosis occur; avoid in patients at increased risk.
Supported by Warnings and Precautions (5.5), including prompt evaluation, discontinuation on symptoms, and avoidance in patients at increased risk.

Unsupported Statements

Specific dose statements restricting tofacitinib tablets 10 mg twice daily (or tofacitinib extended-release tablets 22 mg once daily) are not recommended for RA/PsA/AS/pcJIA.
Partially supported. The cited label sections in the AI evaluation are warning sections (5.2–5.4) that reference not-recommended dosing for certain indications, but the response’s audit anchoring does not clearly point to the precise dosing/indication restriction language/location (e.g., a dedicated Dosage and Administration/Not recommended statement for those indications).

Contradictions


Important Omissions

If the full AI response (not provided here) claimed additional elements such as contraindications, boxed warning exact wording/coverage beyond the selected themes, or specific drug-interaction and pediatric details, these were not evaluated from the provided excerpt and may be materially important depending on what the AI response stated.
Importance: Moderate

Safety Assessment

Potential Patient Risk: Low
Most major safety warning themes are supported by label sections. The main gap is partial support/unclear anchoring for a dose/indication restriction statement rather than a clear contradiction.

Regulatory Assessment

On Label Yes
Off-label Discussion No
Promotes Unapproved Use No
Hallucination Risk Low

Recommendation

Mostly Aligned

Primary Issue
The dose/indication restriction claim is only partially supported because the audit citations do not clearly reference the label’s explicit dosing/usage limitation section(s) and exact restriction wording for RA/PsA/AS/pcJIA.

Suggested Improvement
Anchor the restriction statement to the exact label location/wording that explicitly states the 'not recommended' dose for RA/PsA/AS/pcJIA (e.g., the specific Dosage/Administration 'not recommended' language or the exact 'dosages are not recommended' statement as presented for those indications).