Axplora's Ursodeoxycholic Receives 5-Year Renewed Registration

Published on November 07, 2023

We are delighted to share yet another milestone in Axplora’s journey of innovation and excellence. Our Ursodeoxycholic product, essential in the field of hepatology, has secured a 5-year renewal registration. This accomplishment is underpinned by our dedication to quality, and it underscores Ursodeoxycholic’s important role in improving liver health.

Ursodeoxycholic generic APIs; a cornerstone in hepatology

Ursodeoxycholic, a vital player in hepatology, excels in treating various liver disorders. It’s known for its remarkable efficacy in managing primary biliary cholangitis and dissolving gallstones.

The Axplora Advantage: At Axplora, we take pride in our proprietary “green chemistry” route of synthesis. Here’s how it sets us apart:

  • Reduced Synthesis Steps: We’ve streamlined the process, reducing steps compared to conventional methods starting from Cholic Acid.
  • Higher Process Yield: Thanks to 99% enzymatic conversion, we achieve a superior process yield, making Ursodeoxycholic more economical in the long run.
  • Backward Integration for Raw Material: Through our dedicated company, Pharmachol, with operations in Europe, India, Americas, and Australia, we secure our own key starting material supply. This strategic move ensures consistent quality and availability.

Registrations and Beyond: With our 5-year renewal registration, we are proud to have the following registrations in place:

✓ CEP R1-CEP 2018-115-Rev 00

✓ Indian Certification

Continued Innovation: Axplora remains dedicated to expanding our portfolio in cholic acid derivatives and driving innovation in this strategic space. We are passionate about advancing medical science and improving patient outcomes.

Looking for More? Explore our range of APIs:

  • As one of the leading active pharmaceutical ingredient manufacturers, we specialize in delivering high-quality APIs.
  • Our commitment to excellence extends to ongoing registrations in progress for the Japanese, Russian, and Chinese markets.
  • Axplora offers a variety of API development services to cater to your pharmaceutical needs.
  • With a strong focus on quality, we stand out as one of the trusted API manufacturers in the USA and Europe.
  • For those seeking to enhance their pharmaceutical products, we provide a wide range of chiral chromatography and biocatalysis options.

Interested in learning more about our products? Browse our range of APIs and find the perfect solution to meet your needs. We are proud to be your trusted partner in pharmaceutical innovation and excellence.