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  • lifevisionindia
  • lifevisionindia
  • lifevisionindia
  • lifevisionindia

Lifevision India, the third party pharma manufacturing company in Chandigarh with WHO GMP certification, provides pharma contract manufacturing for the packs of Tramadol 50mg + Diclofenac Sodium 75mg Sustained Release (SR) Tablets. We manufacture these packs for the duly licensed pharma marketers, PCD companies and distributors pan India. Here formulatory excellence is as essential as regulatory honesty, and we ensure both.

Why Does This Analgesic Combination Matters?

Tablets used in combination for pain management, targeting both the brain and the inflammatory site. Tramadol and Diclofenac work together in combination.

Tramadol is an opioid agonist with monaminergic reuptake inhibitory activity. Diclofenac is a selective prostaglandin synthesis inhibitor that is a COX, lipoxygenase and nitric oxide pathway blocker.

This combination proves effective for:

  • Acute musculoskeletal pain
  • Post-operative pain management
  • Osteoarthritis flares

Trials conducted in Indian patients show statistically significant pain relief with Tramadol 50mg + Diclofenac 75mg - all for short five day courses - providing tangible pain relief and validating this combination as an effective short-term pain management option.

Formulation Expertise

Their co-administration is not simple. Patent literature mentions that tramadol hydrochloride and diclofenac sodium are capable of generating a sparingly soluble compound in a suitable medium, which would adversely affect release and bioavailability. The formulation development which we intend to do is based on controlled-release design and development using retarding coating, matrix and layered systems combined with dissolution profile, assay and testing for content uniformity and stability in line with ICH requirements.

Regulatory Compliance Built In

Tramadol is covered under Schedule H1 of the Drugs and Cosmetics Rules and in April 2018 was notified as a psychotropic drug under the NDPS Act. As a responsible importer, we only work with license holders, enforce traceability and support legal labelling requirements including Schedule H1 prescription warning and Rx symbol.

Quality Assurance at Every Stage

From raw material testing, through in-process checks and on to finished product analysis, each batch is subjected to our rigorous release process. This is especially important for this formulation, with our focus on tablet hardness and friability to ensure the controlled release system remains in place, and dissolution tests at multiple time points to ensure release of tramadol and diclofenac occurs as expected. Stability samples are monitored at accelerated and long-term conditions.

Reasons to Partner With Lifevision India

Lifevision India helps new and existing brands get into the pain management category without investing in a plant. Our WHO GMP manufacturing units facilitate right order quantity, fast turnaround time, prompt delivery and transparent communication. Our clients are already comfortable with us as a manufacturer for tablets, capsules and syrups and now you can be too.

What Our Manufacturing Service Covers?

  • Third party and loan licence manufacture of your brand
  • Blister or Alu-Alu packaging with special cartons and labels
  • In-process quality control and batchwise Certificate of Analysis.
  • Regulatory documentation support and on-time delivery

Phone Lifevision India at 8062750200 or email enquiry@lifevisionhealthcarechd.com for your requirement. All questions will be asked as a business to licensed pharma companies, private persons and jobs in no doubt.

Frequently Asked Questions

Q1. Tramadol 50mg and Diclofenac Sodium 75mg SR uses? What are its applications?

Doctors would prescribe it to alleviate acute pain that lasts for short periods of time and is moderate to severe in intensity, such as for pain due to surgery, osteoarthritis and muscle spasms.

Q2. Is a prescription required for this combination?

Yes. As Tramadol is Schedule H1 and NDPS Act so it will be sold on prescription of Registered Medical Practitioner and keeping a record of the medicinal drug.

Q3. Why is diclofenac in sustained release form?

Extended release allows diclofenac to function for hours longer than short-acting preparations, which provides the rationale for BID dosing, and tramadol has a more rapid time to onset of pain relief in the formulations studied.

Q4. Who can order this product from Lifevision India?

We welcome to partner you licensee pharma merchants, PCD firms and vendors carrying legitimate drugs licenses not for every one of the enquiries.

Q5. What quality checks are performed on each batch?

In the following we provide some things to test: assay, dissolution, content uniformity, hardness, friability and stability, along with a batch-wise Certificate of Analysis.