Anti-epileptic / neuropathic pain API
Pregabalin API Manufacturer & Supplier in India
Apex Pharma API is a Pregabalin API manufacturer and supplier based in India, producing bulk active pharmaceutical ingredient for pharmaceutical formulation companies, distributors and R&D teams. We manufacture Pregabalin in-house at our Saykha GIDC plant to the documentation and quality standards B2B buyers rely on when qualifying a new supplier.
What is Pregabalin API?
Pregabalin (CAS No. 148553-50-8) is a gamma-aminobutyric acid (GABA) analogue belonging to the gabapentinoid drug class. It acts on the alpha-2-delta subunit of voltage-gated calcium channels in the central nervous system and is used in the formulation of anticonvulsant, neuropathic-pain and anxiolytic medicines. Pregabalin is marketed globally under the brand name Lyrica; Apex Pharma API manufactures and supplies the API itself, not the finished branded or generic product.
For a formulator, the practical point is that the same molecule feeds several dossiers under different regional monographs. A supplier who can cover IP, BP, USP and EP from one route saves you qualifying a second source.
Pregabalin API manufacturing at Apex Pharma API
We have manufactured Pregabalin in-house since 2015 on a single established route at our Saykha GIDC plant, which is why the impurity profile does not move between campaigns. Production runs in a 4 KL stainless-steel reactor at up to 600 kg per batch, so we supply from evaluation samples through to repeat commercial volumes. Our complete product range and general sourcing process are covered on our API manufacturing page.
Applications and uses
Pregabalin API is used in the formulation of medicines for neuropathic pain — including diabetic peripheral neuropathy and postherpetic neuralgia — as adjunctive therapy for partial-onset seizures, and, depending on the approved indication in a given market, for fibromyalgia and generalized anxiety disorder. This is general pharmacological context for buyer understanding, not a claim about specific finished products manufactured by our customers.
Industries and customers we serve
Pregabalin API from Apex Pharma API is supplied to pharmaceutical formulation manufacturers producing tablets and capsules, to distributors supplying API onward within their own network, and to R&D and generic-development teams needing API for formulation trials ahead of scale-up. Our full buyer-segment breakdown is on the API manufacturing companies in India page.
Pregabalin API export and supply considerations
Pregabalin is classified as a Schedule V controlled substance under the U.S. Controlled Substances Act — the least restrictive DEA schedule — and is scheduled differently in other markets (Class C in the UK, for example). This affects manufacturing, distribution, import and export controls, so any buyer sourcing Pregabalin API for onward export should confirm the requirements of their destination country. We supply non-regulated export markets, with export documentation prepared in-house.
Why choose Apex Pharma API for Pregabalin API
- A DMF is filed for the IP, BP and USP grades — supporting your regulated-market filing rather than leaving documentation to chase later.
- GMP- and GLP-certified manufacturing (Gujarat FDCA), with an ISO 9001:2015 quality management system and MSME ZED Bronze certification.
- A single established route since 2015, so the impurity profile is consistent campaign to campaign.
- Manufacturer pricing, quoted directly — you are buying from the plant that makes it, with a batch CoA as standard.
Product & technical information
| Product name | Pregabalin (bulk active pharmaceutical ingredient) |
|---|---|
| CAS number | 148553-50-8 |
| Drug class | Gabapentinoid / GABA analogue |
| 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.
Quality & compliance
Manufactured under GMP and GLP certificates from the Gujarat FDCA, with an ISO 9001:2015 quality management system and MSME ZED Bronze certification. A batch-wise Certificate of Analysis is issued as standard, and everything your QA and regulatory teams need is available at quotation stage.
DMF filed for IP, BP and USP grades
Pregabalin API — frequently asked questions
What is Pregabalin API used for?
It is the active ingredient in medicines for neuropathic pain, certain seizure disorders and anxiety-related conditions, depending on the finished formulation and the approved indication in a given market.
Is Pregabalin the same as Lyrica?
Lyrica is the original brand name for Pregabalin. Apex Pharma API supplies the API itself — the bulk active ingredient — not the branded or generic finished product.
Is Pregabalin a controlled substance?
Scheduling varies by country — it is a Schedule V substance in the United States and Class C in the UK, and controls differ elsewhere. Export buyers should confirm the requirements of their destination market as part of their own compliance process.
Does Apex Pharma API export Pregabalin?
Yes. We supply non-regulated export markets, with export documentation prepared in-house at our Bharuch plant. Share your destination and we will confirm what is required before you order.
What grades of Pregabalin API do you supply?
IP, BP, USP and EP grades, against the applicable pharmacopoeial monograph. A Drug Master File has been filed for the IP, BP and USP grades.
Is a Certificate of Analysis provided with each batch?
Yes. A batch-wise Certificate of Analysis is issued as standard with every despatch, alongside the MSDS, specification sheet and method of analysis.
What is the minimum order quantity?
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.
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.