Tranexamic Acid Injection Manufacturer & Supplier in India
Heavy bleeding doesn’t wait for paperwork, which is why Tranexamic Acid Injection sits in nearly every trauma kit, OT tray, and postpartum hemorrhage protocol across Indian hospitals today. Smayan Injectables manufactures this antifibrinolytic under WHO-GMP conditions and supplies it to PCD franchise partners, hospital procurement networks, and third-party/contract manufacturing clients across India.
India’s injectable pharma sector has matured fast, and Revised Schedule M compliance is now table stakes, not a differentiator. So buyers evaluating suppliers this year tend to dig deeper than a certificate — this page covers what’s actually worth checking before you sign on.
Product Specifications & Composition
Every batch is produced under sterile aseptic conditions and meets Revised Schedule M requirements.
| Parameter | Specification |
|---|---|
| Product Name | Tranexamic Acid Injection IP / BP / USP |
| Composition | Tranexamic Acid IP 100 mg/ml (500 mg / 5 ml) |
| Preservative | Benzyl Alcohol IP 2% v/v (preservative-free variant available) |
| Therapeutic Class | Antifibrinolytic / Hemostatic Agent |
| Packaging | 5 ml ampoules, tray pack of 5×5 ml with mono carton |
| Primary Container | USP Type I neutral glass, amber or clear ampoules |
| Shelf Life | 24–36 months |
| Certifications | WHO-GMP, ISO 9001:2015, Revised Schedule M |
Pricing
Tranexamic Acid Injection pricing depends on order volume, packaging customization, and whether it’s a bulk domestic order or an export shipment. Get in touch for current wholesale and bulk rates — we quote based on your specific requirement rather than a fixed list price, since packaging and MOQ change the economics significantly.
Where This Drug Actually Gets Used
Tranexamic acid isn’t a niche molecule — it’s a workhorse across four clinical settings:
- Postpartum hemorrhage (PPH): One of the first-line injectables obstetric teams reach for to control post-delivery blood loss.
- Surgical bleeding: Orthopedic replacements, open-heart procedures, liver transplants, and prostate surgery all use it to cut down on intraoperative transfusion volumes.
- Trauma and emergency care: A standard component of resuscitation protocols for internal bleeding after major injury.
- Dental surgery: Particularly useful for hemophilia and clotting-disorder patients who’d otherwise bleed for hours after a routine extraction.
That range of use — obstetrics, surgery, trauma, dentistry — is exactly why demand for a dependable, WHO-GMP supply source keeps climbing, especially as tier-2 and tier-3 hospital networks expand their surgical and maternity infrastructure.
Why Buyers Choose Smayan Injectables
Sterile fill-finish under real HVAC control. Not just a certificate on the wall — the filling lines run under validated air-handling systems that keep contamination risk close to zero.
Third-party manufacturing, done properly. Custom packaging artwork, your choice of vial or ampoule, and turnaround times that don’t blow up your launch calendar.
Monopoly PCD rights. Exclusive territory, marketing collateral, and distribution support — so you’re not competing against five other distributors selling the same SKU in the same district.
Testing that isn’t skipped to hit a deadline. Sterility, clarity, bacterial endotoxin (LAL), and assay testing on every single batch before it ships, not just on the first few.
How Smayan Stacks Up Against Typical Suppliers
Not every WHO-GMP claim on a pharma supplier’s website means the same thing in practice. Here’s what actually separates a serious manufacturer from one that’s just printing the logo:
| What to check | Typical smaller supplier | Smayan Injectables |
|---|---|---|
| MOQ flexibility | Rigid, often 20,000+ units minimum | Standard batches from 5,000–10,000 ampoules |
| COA per batch | Sometimes bundled or delayed | Issued with every dispatch, no exceptions |
| Preservative-free option | Rarely stocked | Available on request |
| Artwork turnaround | Weeks of back-and-forth | Finalized early in onboarding, before production starts |
| Logistics | Standard freight | Temperature-controlled dispatch for cold-chain integrity |
If you’re evaluating multiple manufacturers, ask for their last three COAs and their actual LAL test turnaround time — that’s usually where the gap between “certified” and “consistent” shows up.
Onboarding for Third-Party Manufacturing
- Share your requirement — batch size, packaging preference, delivery timeline, and get a quote back.
- Submit your license. Drug License (Form 20B/21B) and GST registration, verified before anything moves forward.
- Lock the artwork. Carton design, label copy, and foil specs finalized and approved.
- Production and testing. Manufacturing runs under WHO-GMP conditions, followed by full COA generation.
- Dispatch. Temperature-controlled freight, pan-India.
FAQs
Q1. What’s the minimum order quantity for third-party manufacturing?
Ans. It depends on your packaging customization, but standard commercial batches start at 5,000–10,000 ampoules.
Q2. Does every batch come with a Certificate of Analysis?
Ans. Yes — COA, GST invoice, and full batch production documentation ship with every order, no separate request needed.
Q3. Is Smayan Injectables’ Tranexamic Acid Injection Revised Schedule M compliant?
Ans. Yes. All manufacturing runs under Revised Schedule M and WHO-GMP standards, which are now mandatory for every Indian injectable manufacturer.
Q4. What is the price of Tranexamic Acid Injection?
Ans. Pricing depends on order quantity, packaging, and destination (domestic or export). Reach out for a current quote based on your specific requirement.
Q5. Does Smayan Injectables export Tranexamic Acid Injection?
Ans. Yes, we supply to international buyers with export documentation and packaging adapted to destination-country requirements.
Q6. What are the common side effects of Tranexamic Acid Injection?
Ans. Like any prescription medication, it can cause side effects in some patients. Dosage, administration, and any concerns about side effects should always be discussed with the prescribing physician — this page is for sourcing and manufacturing information, not clinical guidance.
Q7. How should Tranexamic Acid Injection be stored?
Ans. Store as per the label instructions, typically at room temperature and protected from light. Follow the specific storage conditions printed on the pack for the batch you receive.