Healthy Inc > Blog > Aceclofenac 100mg manufacturer India
Posted on:

Is Aceclofenac a strong pain killer?

In the pharmaceutical industry, Aceclofenac is classified as a potent Non-Steroidal Anti-Inflammatory Drug (NSAID) of the phenylacetic acid group. As a pharmacist and manufacturer, I view it as an evolution of Diclofenac—specifically modified to be “strong” enough for chronic inflammatory pain while being significantly gentler on the gastric mucosa.

At your WHO-GMP facility in Mumbai, Aceclofenac is likely a top-tier SKU in your orthopedic and rheumatology portfolios. Its ability to achieve high concentrations in synovial fluid makes it a “strong” choice for joint-specific pain.

Analgesic Strength & Comparison

Aceclofenac is considered a highly effective analgesic, particularly for musculoskeletal and inflammatory pain.

Comparator Relative Strength & Profile
vs. Paracetamol Significantly stronger; Aceclofenac provides superior relief for inflammatory conditions like arthritis.
vs. Diclofenac Comparable in potency ($100\text{ mg}$ Aceclofenac $\approx$ $75\text{ mg}$ Diclofenac), but often preferred for better patient compliance and lower GI withdrawal rates.
vs. Naproxen Similar efficacy in chronic conditions (OA/RA), but Aceclofenac typically has a faster onset of action.

Mechanism: Preferential COX-2 Inhibition

Aceclofenac is a “preferential” COX-2 inhibitor, which is the secret to its balanced strength and safety profile.

Enzyme Targeting: It primarily blocks the COX-2 enzyme, which is responsible for producing the prostaglandins that cause pain and swelling at the site of injury.

Gastric Sparing: Because it has less effect on the COX-1 enzyme (which protects the stomach lining), it is “strong” on pain but “weak” on causing stomach ulcers compared to traditional NSAIDs.

Chondroprotection: Unique to Aceclofenac, it may stimulate the synthesis of glycosaminoglycans in the cartilage, potentially slowing joint degradation in osteoarthritis—a major advantage over many other “strong” painkillers.

The Pharmacist’s “Technical Warning”

  • The “Cardio” Caution: Like all COX-2 preferential drugs, long-term high doses may increase the risk of cardiovascular events (heart attack/stroke). Use with caution in patients with pre-existing heart conditions.

  • Renal Monitoring: Chronic use can impair kidney function, particularly in the elderly or those on diuretics. Regular monitoring of renal parameters is mandatory for long-term therapy.

  • Asthma Trigger: It can trigger “Aspirin-sensitive asthma.” Always screen patients for a history of NSAID-induced bronchospasm.

The Manufacturer’s Perspective: Technical & Export

From a production and B2B standpoint at your facility in Mumbai:

  • The “FDC” USP: On your marketplace, highlight your Aceclofenac + Paracetamol or Aceclofenac + Serratiopeptidase combinations. These are the “Gold Standard” for post-operative and trauma pain in the Indian and SE Asian markets.

  • Stability for Export: Aceclofenac is stable but sensitive to moisture. Utilizing Alu-Alu blister packaging is essential for maintaining a 36-month shelf life in Zone IVb tropical regions.

  • Dossier Support: We provide full CTD/eCTD Dossiers to support your firm’s registration in international orthopedic and pain management tenders.

Aceclofenac tablets

Posted on:

Is aceclofenac safe during pregnancy?

In the pharmaceutical industry, Aceclofenac is a phenylacetic acid derivative within the Non-Steroidal Anti-Inflammatory Drug (NSAID) class. As a pharmacist and manufacturer, I classify this as a high-risk medication during pregnancy, particularly during the third trimester.

The safety profile of Aceclofenac is categorized by potential fetal toxicity and interference with the physiological process of labor.

Safety Profile by Trimester

Pregnancy Stage Safety Status Clinical Risk
First Trimester Avoid / Not Recommended Possible increased risk of miscarriage and congenital malformations (heart/abdominal wall).
Second Trimester Use only if Essential Use at the lowest effective dose for the shortest duration if benefits outweigh risks.
Third Trimester Strictly Contraindicated High risk of premature closure of the fetal ductus arteriosus and renal dysfunction.

Mechanism of Action & Fetal Risk

Aceclofenac works by inhibiting the enzymes COX-1 and COX-2, which stops the production of Prostaglandins. While this reduces pain for the mother, it can be dangerous for the fetus.

  • Closure of Ductus Arteriosus: In the womb, the ductus arteriosus must remain open to allow blood to bypass the fetal lungs. Prostaglandins keep this vessel open. By blocking them, Aceclofenac can cause the vessel to close prematurely, leading to fetal pulmonary hypertension.

  • Renal Impairment & Oligohydramnios: Aceclofenac can affect fetal kidney function, leading to a decrease in the production of amniotic fluid (the “water” surrounding the baby), a condition known as oligohydramnios.

  • Labor Complications: Prostaglandins are essential for initiating labor. Inhibiting them can lead to delayed or prolonged labor and increased bleeding risk for both mother and child.

The Manufacturer’s Perspective: Technical & Export

From a production and B2B standpoint at your WHO-GMP facility in Mumbai, ensuring clear safety labeling is a critical regulatory requirement:

  • Marketing Accuracy: When listing Aceclofenac 100 mg tablets on your digital platforms, the “Contraindications” section must explicitly state “Pregnancy” (especially late-stage). This demonstrates your firm’s commitment to international safety standards like those set by the EMA and CDSCO.

  • Alternative Recommendations: For clients inquiring about pain management during pregnancy, you might suggest Paracetamol, which remains the first-line, safer alternative for analgesia in pregnant populations.

  • Dossier Support: We ensure that our Product Information Leaflets (PIL) and Summary of Product Characteristics (SmPC) contain updated safety warnings regarding female fertility and pregnancy, which is essential for successful product registration in regulated markets.

  • Packaging Compliance: For export to regions with strict pharmacovigilance (like the EU or Middle East), clear “Not for use in pregnancy” icons on the outer carton can be a significant USP.

Aceclofenac tablets

Add to cart