Anti-epileptic / neuropathic pain API
Pregabalin API
Manufactured in-house at our Saykha GIDC plant in IP, BP, USP and EP grades — supplied with batch CoA as standard and DMF support for regulated filings.
Overview
Pregabalin is a gamma-aminobutyric acid analogue used in formulations for neuropathic pain, epilepsy adjunct therapy and generalised anxiety disorder. It is one of the highest-demand oral solid APIs in the Indian market, which makes supply reliability — not just price — the deciding factor for most formulators.
Apex Pharma API has manufactured Pregabalin since 2015 on a single established route, which is why our impurity profile does not move between campaigns. You buy directly from the plant that makes it, with the QC team that released the batch available to answer your questions.
Specifications
| Product name | Pregabalin (bulk active pharmaceutical ingredient) |
|---|---|
| CAS number | 148553-50-8 |
| Molecular formula | C8H17NO2 |
| Molecular weight | 159.23 |
| Grades available | IP · BP · USP · EP |
| Appearance | White to off-white crystalline powder |
| Assay | Per applicable pharmacopoeial monograph (grade-specific) |
| Packaging | 1 kg / 5 kg / 25 kg — HDPE drum with double LDPE liner; other configurations on request |
| Storage | Store in a tightly closed container, protected from light and moisture, at controlled room temperature |
| Supply capacity | Up to 600 kg per batch in a 4 KL stainless-steel reactor, around 25 batches per month; trial to commercial volumes confirmed at quotation |
Full specification sheet and method of analysis issued with the quotation. Packaging and storage confirmed per destination market.
Applications
Capsules and tablets for diabetic peripheral neuropathy and post-herpetic neuralgia.
Add-on therapy formulations for partial onset seizures.
Oral solid dosage forms in markets where the indication is approved.
Fixed-dose combinations where a consistent impurity profile is critical.
Regulatory & documentation
Everything your QA and regulatory teams need to open a file on us, issued at quotation stage rather than after the order.
DMF filed for IP, BP and USP grades
Pregabalin API — buyer questions
What is the MOQ for Pregabalin API?
We supply from trial quantities upward. The commercial MOQ is confirmed against your grade and packaging requirement at quotation — it is not a fixed number across all buyers.
Can I get a sample with a CoA?
Yes. Evaluation samples are issued with the batch CoA so your QC team can verify against your own specification before you raise a PO.
How long is the lead time?
Stocked grades despatch within days of order confirmation. Campaign quantities are scheduled and a firm date is given before you commit.
Is a DMF available for filings?
Yes. A Drug Master File has been filed for Pregabalin covering the IP, BP and USP grades. Tell us your destination market and filing type and we will confirm what we can share and how.
Related products
Read: Pregabalin uses and applications →Get a Pregabalin API quote
Grade, quantity, destination — we will come back with price, lead time and documentation.