Ropivacaine Injection Manufacturer in India

WHO-GMP certified sterile manufacturing of Ropivacaine injection — 2mg/mL, 7.5mg/mL and 10mg/mL ampoules — for epidural, spinal and peripheral nerve block anaesthesia.

Key Highlights

  • Ropivacaine HCl 2mg/mL · 7.5mg/mL · 10mg/mL · Ampoule
    Ampoule

  • WHO-GMP Certified
    · Sterile Cleanroom

  • DCGI Approved
    Export-Ready

Product Details

Ropivacaine Injection — manufactured at 9M India

 

Product Specifications

  • Generic Name: Ropivacaine Hydrochloride
  • Strength: 2mg/mL (0.2%) · 7.5mg/mL (0.75%) · 10mg/mL (1%)
  • Dosage Form: Solution for Injection
  • Route: Epidural · Spinal · Peripheral nerve block
  • Container: Type I glass ampoule — 10mL · 20mL
  • Closure: Heat-sealed ampoule
  • Storage: Store below 30°C · Protect from light
  • Shelf Life: 24 months
  • Manufacturing: WHO-GMP certified sterile cleanroom · Grade A/B aseptic fill-finish
  • Regulatory Status: DCGI approved · Manufacturing licence held
  • Available For: Contract manufacturing · Third-party manufacturing · Direct supply

Ropivacaine is a long-acting amide local anaesthetic preferred for epidural anaesthesia in labour, post-operative pain management and peripheral nerve blocks. Its greater cardiotoxic safety margin compared to Bupivacaine makes it the preferred choice for high-dose regional anaesthesia techniques. Increasingly specified in anaesthesia formularies at surgical hospitals and used extensively in obstetric anaesthesia programmes.

Enquire Now

    Manufacturing & Compliance

    How Ropivacaine Injection is manufactured at 9M India

    • Sterile cleanroom manufacture

      Ropivacaine HCl aqueous solution is prepared with pH adjustment to the 4.0–6.0 range for chemical stability and pharmacopoeial compliance. Sterile-filtered through 0.22 micron membrane and aseptically filled into heat-sealed Type I glass ampoules under Grade A laminar airflow in classified cleanroom. Three strengths manufactured on validated processes.

    • In-house QC release testing — every batch

      Sterility · Bacterial endotoxins · pH (4.0–6.0) · Assay by HPLC (95.0–105.0%) · Related substances · Enantiomeric purity (S-enantiomer content) · Visible particulate matter — all tested in-house. COA per batch.

    • Documentation available within 24 hours

      DCGI manufacturing licence · WHO-GMP Certificate · Certificate of Analysis · Certificate of Conformance · Stability data (real-time and accelerated, ICH-aligned) · Batch manufacturing record summary — pre-prepared and available within 24 hours for tender submission, export registration or CDMO due diligence.

    Need Ropivacaine injection manufactured to WHO-GMP standards?

    Tell us your strength, ampoule size, volumes and target market. We confirm availability within 24 hours.

    • WHO-GMP
      Certified

    • DCGI
      Approved

    • In-House
      QC

    • Contract & 3PM
      Available

    We keep answer short

    Frequently asked questions — allergy & cns syrups

    • 01

      Yes. 9M India manufactures Cetirizine Hydrochloride 5mg/5ml syrup at its WHO-GMP certified facility in Birkoni, Chhattisgarh. Cetirizine is a second-generation non-sedating antihistamine — the most widely prescribed antihistamine oral liquid globally for allergic rhinitis, urticaria and allergic conjunctivitis in adults and children from 2 years. Sugar-free formulation is available.

    • 02

      Cyproheptadine 2mg/5ml syrup is a first-generation antihistamine with unique antiserotonergic activity that stimulates appetite. It is widely used as an appetite stimulant for children with poor growth and undernutrition — a high-prevalence condition in Sub-Saharan Africa and South Asia. It is also used for allergic conditions, urticaria and migraine prophylaxis. 9M India manufactures Cyproheptadine syrup at scale for export to these high-demand markets.

    • 03

      Yes. 9M India manufactures Promethazine Hydrochloride 5mg/5ml syrup — a first-generation antihistamine with antiemetic, sedative and anticholinergic properties. Promethazine is widely used for allergic conditions, motion sickness, nausea and vomiting, pre-anaesthetic medication and as a sedative. It is a WHO Essential Medicine and one of the highest-volume antihistamine syrups in export markets.

    • 04

      Yes. 9M India manufactures antiepileptic oral liquid formulations including Phenobarbitone Syrup 20mg/5ml and Levetiracetam Oral Solution 100mg/ml for paediatric epilepsy management. These are essential medicines for children who cannot swallow tablets — a consistent institutional demand item in hospital paediatric neurology departments and government epilepsy programmes globally.

    • 05

      First-generation antihistamines (Promethazine, Chlorpheniramine, Cyproheptadine) cross the blood-brain barrier — causing sedation, which is a side effect in allergy treatment but a therapeutic benefit in nausea, pre-anaesthesia and sleep. Second-generation antihistamines (Cetirizine, Levocetirizine) do not significantly cross the blood-brain barrier — providing anti-allergic benefit without sedation. Both generations are in active export demand and 9M India manufactures syrup formulations across both classes.

    • 06

      Yes. Sugar-free antihistamine syrup formulations — using Sorbitol, Sucralose or Saccharin as sweeteners — are available for Cetirizine, Cyproheptadine and Chlorpheniramine. Sugar-free formulations are preferred for diabetic patients and in paediatric populations where sugar-containing syrups may contribute to dental caries. Please specify sugar-free requirement when placing an enquiry.

    • 07

      Documentation available includes WHO-GMP Certificate, DCGI Manufacturing Licence, Certificate of Pharmaceutical Product (CoPP), batch-wise Certificate of Analysis, ICH Zone IVb stability data and CTD/ACTD dossiers on request. For antiepileptic oral liquids classified as controlled or scheduled substances in certain markets, our regulatory team can advise on the appropriate export permit and documentation requirements.

    • 08

      Antihistamine syrup demand is highest in the Middle East, North Africa and South Asia — where allergic rhinitis and urticaria prevalence is elevated due to high dust and pollen burden, dry climatic conditions and increasing pollution levels. These are 9M India's primary Phase 1 export markets. Cyproheptadine appetite stimulant syrup shows particularly high demand in Sub-Saharan Africa where paediatric nutritional programmes drive significant volume.

    Looking for something specific?

    At 9M India Limited, trust through quality, transparency, performance.