UDINIT-300 TAB

What is Ursodeoxycholic Acid (UDCA)?

Ursodeoxycholic Acid (UDCA), a bile acid naturally produced in the body, treats liver and gallbladder diseases. It shifts the cholesterol level in bile, making it less saturated and more fluid. This increases bile flow and protects liver cells from the harmful effects of bile acids. Doctors usually prescribe UDCA for liver diseases such as primary biliary cholangitis, cholestatic liver diseases, and those caused by cholesterol gallstones.. It’s helping alongside the normalization of liver enzyme levels in total liver function. For its remarkable safety and effectiveness, UDCA has become one of the most widely used APIs in gastroenterology and hepatology clinical practice all over the world. Consequently, the market for ursodeoxycholic acid manufacturers in India gets the benefits of increased demand.

On top of this, the global market for Ursodeoxycholic Acid (UDCA), consisting of 300 mg tablet formulations, is growing slowly and steadily due to the increase in the number of people suffering from liver and biliary diseases such as primary biliary cholangitis (PBC), gallstones, and non-alcoholic fatty liver disease, which in turn leads to a sustained prescription demand. UDCA has been a trusted therapeutic agent for both liver function improvement and cholesterol gallstone dissolution, which is why its clinical use flows continuously throughout the entire world.

Ursodeoxycholic Acid (UDCA) Production Process

Ursodeoxycholic acid manufacturers in India, who are the most prominent and most recognized in the country, have been working under a very stringent and standardized procedure that tries to achieve and sustain pharmaceutical-grade purity and potency of the produced UDCA. The first step in this long and complicated process is to collect superior-quality raw materials or appropriate precursors that comply with the given regulations. Manufacturers then use precise chemical or biotechnological synthesis to create UDCA with the necessary molecular structure.

Besides, the compound created undergoes a long and complicated procedure of purification comprising crystallization and filtration to get rid of the impurities and by-products. The UDCA after purification is subjected to drying and milling, and its identity, purity, and potency are confirmed by various sophisticated analytical techniques. After that, the final product, the active pharmaceutical ingredient (API), is packed under GMP-controlled conditions to keep its stability. Thus, the API can be used for the production of pills, capsules, or other oral forms of administration.

Quality Standards Observed by Leading Ursodeoxycholic Acid Suppliers

Nitro Organics, the foremost ursodeoxycholic acid distributor in India, maintains the highest quality standards and certifications as per the following criteria:

• Manufacturing in plants certified by WHO-GMP
• Adherence to pharmacopoeial regulations of IP, BP, USP, and EP
• Thorough acceptance of raw materials and verification of suppliers
• Production and purification methods validated
• Manufacturers apply quality control at every stage of production.
• Analytical testing of high sophistication (HPLC, GC, etc.)
• Detection of impurities and potency validation
• Non-stop consistency and traceability over the production process
• Stability studies for shelf-life guarantee
• Complete regulatory documentation for domestic as well as export markets

The Most Important Uses of Ursodeoxycholic Acid Tablets IP 300 mg

• Treatment of primary biliary cholangitis (PBC) and liver function improvements
• Dissolution of cholestatic liver disorders through improved bile flow
• Cholesterol gallstones that are free of surgery dissolve in the patients
• Taking out unwanted bile acids in the liver
• Enhancement of the liver enzyme levels in chronic liver diseases
• NAFLD treatment: a supportive therapy
• Liver cell protection against bile damage
• Post liver transplant, an additional treatment is needed to ensure bile circulation.

Why Choose Nitro Organics, a Trusted Indian Manufacturer of Ursodeoxycholic Acid?

Ursodeoxycholic acid manufacturers in India, like Nitro Organics, assure their pharmaceutical partners regarding the safety, efficacy, and quality of the drugs. To add more, the WHO-GMP- and ISO-certified facilities implement very high-quality control standards and use the most modern manufacturing techniques. We have a very good R&D team and broad regulatory expertise. This results in accurate formulations, consistent quality between batches, and compliance with all local and international laws. What is more, we have always been the trustworthy partner for pharmaceutical logos that wish to keep their products’ reputation untainted. Therefore, our services not only facilitate the clients’ entrance into new markets but also assist them in establishing a durable image in the global pharmaceutical market.