API Manufacturing
API Manufacturers in India — Bulk Active Pharmaceutical Ingredient Supply
Apex Pharma API manufactures and supplies Active Pharmaceutical Ingredients to pharmaceutical formulation companies, distributors, exporters and R&D buyers across India. Our current range covers eight molecules, all made at our own GMP-certified plant at Saykha GIDC, Bharuch.
The basics
What is an Active Pharmaceutical Ingredient (API)?
An Active Pharmaceutical Ingredient is the biologically active component of a medicine — the substance responsible for its therapeutic effect, before it is combined with excipients and processed into a finished dosage form such as a tablet, capsule or injection. The EU GMP Guide (Part II) defines an API as any substance intended for use in manufacturing a drug product that becomes an active ingredient of that drug; the World Health Organization applies a parallel standard through its API prequalification procedure.
In practice, an API manufacturer's core responsibility is not just producing the compound — it is producing it consistently, batch after batch, to a defined specification a formulator can rely on.
Our range
What we manufacture and supply
| Product | CAS number | Primary use category | Link |
|---|---|---|---|
| Pregabalin API | 148553-50-8 | Anti-epileptic / neuropathic pain | View Details → |
| Metaxalone API | 1665-48-1 | Skeletal muscle relaxant | View Details → |
| Flupirtine Maleate API | 75507-68-5 | Non-opioid analgesic | View Details → |
| Fenofibrate API | 49562-28-9 | Lipid-regulating agent | View Details → |
| Metadoxine API | 74536-44-0 | Hepatoprotective | View Details → |
| Itopride Hydrochloride API | 122892-31-3 | Prokinetic / gastrointestinal | View Details → |
| Flunixin Meglumine API | 42461-84-7 | NSAID (veterinary formulation) | View Details → |
| Lacosamide API | 175481-36-4 | Anti-epileptic | View Details → |
Full specifications, available pharmacopoeial grades and product-specific documentation are on each product's own page.
Who we supply
Who sources from us
Sourcing API for tablet, capsule or injectable production, with the documentation your QA team needs before the first PO.
Supplying API onward within their own network, or exporting — we supply non-regulated export markets.
Needing API for formulation trials ahead of scale-up, with grade flexibility and impurity data while the product is still in development.
Regulatory context
API manufacturing regulation in India
API manufacturing in India is regulated by the Central Drugs Standard Control Organisation (CDSCO), under the office of the Drugs Controller General of India (DCGI). A manufacturer producing API for the Indian market or for export typically operates under a drug manufacturing licence issued by the State Licensing Authority, with CDSCO holding central jurisdiction over certain categories.
Apex Pharma holds drug manufacturing licences G/25/2487 and G/28/1820 (Forms 25 & 28) issued by the Gujarat Food & Drugs Control Administration under the Drugs & Cosmetics Act 1940, permitting the manufacture of Bulk Drugs (APIs) under Revised Schedule M. This regulatory layer exists to ensure the API reaching a formulator's production line is traceable, consistently manufactured and backed by real documentation.
Quality & compliance
Quality, documentation & compliance
Before placing an order, a buyer sourcing API from a new supplier will typically check the facility's certification status, DMF availability, per-batch CoA, and pharmacopoeial grade. Here is where we stand.
Full certification detail, with numbers and validity →Gujarat FDCA certificates for Bulk Drugs (APIs) under Revised Schedule M, plus an in-house GLP testing laboratory.
A documented quality management system (ICV) and MSME ZED Bronze certification.
A batch-wise Certificate of Analysis issued as standard, confirming the batch meets specification.
A DMF is filed for Pregabalin (IP/BP/USP); IP, BP, USP and EP grades are available across the range, by product.
The process
How sourcing from us works
Share the product, required grade and approximate quantity via the contact form or a specific product page.
Relevant specification sheets and available regulatory documents are shared for your internal evaluation.
Buyers evaluating a new supplier can request an evaluation sample, issued with a batch CoA, ahead of a bulk order.
Once specification and commercial terms are agreed, the order is confirmed and scheduled.
Product is dispatched with batch-specific documentation, including the Certificate of Analysis.
Why Apex
Why buyers source from Apex Pharma API
If you need a molecule developed rather than sourced, see API CDMO / Custom Synthesis; if you need us to manufacture your own established process, see Contract Manufacturing.
Eight molecules across human and veterinary segments — not a broad generalist catalogue we cannot stand behind.
Our own plant at Saykha GIDC, Bharuch, with in-house R&D, QC, QA and despatch — a supply history you can check.
GMP and GLP (Gujarat FDCA), ISO 9001:2015 and MSME ZED Bronze — each certificate is shown, with number and validity, on our quality page.
Batch-wise CoA as standard, DMF filed for Pregabalin (IP/BP/USP), and the full specification set at quotation stage.
API manufacturing FAQs
What's the difference between an API and a finished pharmaceutical product?
The API is the active compound itself — usually a powder — before it is combined with excipients and processed into a tablet, capsule or other dosage form. A formulation company purchases the API and manufactures the finished product; Apex Pharma API supplies the former, not the latter.
Is a Drug Master File (DMF) the same as a GMP certificate?
No. A GMP certificate confirms the manufacturing facility itself meets Good Manufacturing Practice standards. A DMF is product-specific documentation submitted to a regulatory authority describing how that particular API is manufactured, tested and controlled — buyers in regulated export markets often require both.
What is the minimum order quantity (MOQ) for your APIs?
MOQ varies by product. We supply from trial quantities upward and confirm the exact MOQ against your grade and volume at quotation, rather than applying one blanket figure.
Do you provide a Certificate of Analysis (CoA) with every batch?
Yes. A batch-wise Certificate of Analysis is issued as standard with every despatch, alongside the MSDS, specification sheet and method of analysis.
Can I request a sample before placing a bulk order?
Yes. Evaluation samples are issued with the batch CoA so your QC team can test against your own specification before raising a purchase order.
Do you supply outside India?
Yes. We supply non-regulated export markets, with export documentation prepared in-house at our Bharuch plant.
What pharmacopoeial grades are available — IP, BP, USP, EP?
Grade availability differs by product and is confirmed on each individual product page — see the product table above.
Looking to source one of our APIs?
Request a quote, or explore API CDMO if you need a molecule developed, or Contract Manufacturing if you need your own formulation produced.