Pantoprazole Sodium Sesquihydrate API Manufacturers & Suppliers in India

Introduction

Pantoprazole is a widely used pharmaceutical compound belonging to the class of proton pump inhibitors (PPIs). The chemical form Pantoprazole Sodium Sesquihydrate, with the CAS number 138786-67-1, plays a critical role in treating gastrointestinal disorders such as gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome. Pantoprazole works by reducing the amount of stomach acid produced, thus providing relief from conditions caused by excessive acid production.

As a highly potent and semi-synthetic API, Pantoprazole Sodium Sesquihydrate has a significant demand in both domestic and international pharmaceutical markets. India, being a global leader in the pharmaceutical industry, plays a crucial role in the production and supply of high-quality Pantoprazole Sodium Sesquihydrate API. In this article, we will explore the key aspects of Pantoprazole Sodium Sesquihydrate API, its manufacturing process, and why India is a preferred destination for sourcing this vital compound.

What is Pantoprazole Sodium Sesquihydrate?

Pantoprazole Sodium Sesquihydrate (CAS number 138786-67-1) is a chemical compound in its sodium salt form, often found as a sesquihydrate, which means it contains one and a half molecules of water for each molecule of Pantoprazole Sodium. This form of the drug is widely used in the treatment of various acid-related disorders due to its ability to inhibit the proton pump in the stomach, reducing the production of stomach acid.

Chemical Structure and Properties

Pantoprazole Sodium Sesquihydrate has the chemical formula C16H15F2N3NaO4S·1.5H2O and is typically a white to off-white crystalline powder that is soluble in water and alcohol. The compound belongs to the family of proton pump inhibitors (PPIs), which include other widely used drugs like Omeprazole and Esomeprazole. Pantoprazole acts by specifically binding to the proton pump (H+/K+ ATPase enzyme) found in the gastric parietal cells, which are responsible for acid secretion.

Pharmacological Action

Pantoprazole Sodium Sesquihydrate is primarily used in the following medical conditions:

• Gastroesophageal Reflux Disease (GERD): A condition where stomach acid frequently backs up into the esophagus, leading to symptoms like heartburn, regurgitation, and discomfort.


• Peptic Ulcers: Pantoprazole helps in healing ulcers by reducing the acid levels in the stomach.


• Zollinger-Ellison Syndrome: A rare condition characterized by tumors in the pancreas or duodenum that result in excessive production of stomach acid.


• Helicobacter pylori Eradication: Pantoprazole is used in combination with antibiotics to help eliminate H. pylori infection, which is linked to the development of ulcers.

Pantoprazole is administered orally in the form of tablets or intravenously in certain severe cases. The medication works by inhibiting the final step of acid production in the stomach, thus providing relief from acid-related gastrointestinal conditions.

Manufacturing of Pantoprazole Sodium Sesquihydrate API

The manufacturing process of Pantoprazole Sodium Sesquihydrate API requires advanced technology, skilled expertise, and adherence to strict regulatory standards to ensure that the product meets the highest quality standards. India is one of the leading producers of Pantoprazole Sodium Sesquihydrate API, owing to its established infrastructure, skilled workforce, and competitive pricing.

Synthesis and Production Process of Pantoprazole Sodium Sesquihydrate

1. Synthesis of Pantoprazole Base: The production of Pantoprazole Sodium Sesquihydrate begins with the synthesis of Pantoprazole base, which is a complex organic compound. The synthesis involves a series of chemical reactions, including Friedel-Crafts acylation, nucleophilic substitution, and sulfonation, to form the core structure of the molecule.


2. Salt Formation: After synthesizing the base compound, it is converted into its sodium salt form (Pantoprazole Sodium) through neutralization with sodium hydroxide (NaOH). The sodium salt form helps improve the solubility of the drug in water, which is necessary for its bioavailability when administered orally.


3. Hydration Process: To produce Pantoprazole Sodium Sesquihydrate, a sesquihydrate molecule (1.5 molecules of water) is added to the sodium salt. This process ensures that the API is stable, bioavailable, and suitable for both oral and intravenous formulations.


4. Purification: After the salt formation and hydration steps, the resulting Pantoprazole Sodium Sesquihydrate undergoes purification. The product is subjected to various purification techniques such as filtration, recrystallization, and washing with solvents to remove any by-products, impurities, or residual solvents that may have been introduced during synthesis.


5. Drying: The purified product is then carefully dried to remove any excess moisture and ensure the final API is in the appropriate crystalline form. The drying process is essential to maintain the stability and potency of the API.


6. Quality Control and Testing: Quality control is a critical step in the manufacturing process of Pantoprazole Sodium Sesquihydrate. Manufacturers perform various tests to ensure the API meets the required specifications, including:
   
   
   
   • Identity Testing: To verify the chemical structure and composition of Pantoprazole Sodium Sesquihydrate.
   
   
   • Purity and Assay Testing: To check the purity of the API and to ensure that the correct dosage is present.
   
   
   • Residual Solvent Testing: To confirm that any solvents used in the production process have been removed to safe levels.
   
   
   • Microbial Testing: To ensure that the API is free from harmful microorganisms.
   
   
   • Stability Testing: To evaluate how stable the API is under various storage conditions and to establish shelf life.
   
   
   
   


7. Packaging and Distribution: Once the API passes all the necessary quality tests, it is packed in suitable containers such as glass bottles, sealed bags, or plastic drums. The packaging is done under controlled conditions to protect the API from contamination or degradation. The final packaged product is then ready for distribution to pharmaceutical companies for the formulation of oral tablets, injectables, or other dosage forms.

Why India is a Hub for Pantoprazole Sodium Sesquihydrate API Production

India has established itself as one of the largest global suppliers of pharmaceutical APIs, including Pantoprazole Sodium Sesquihydrate. Several factors contribute to India's position as a leading producer and supplier of this critical API:

1. Cost-Effective Manufacturing

India offers a significant cost advantage in API production due to its lower labor and operational costs, allowing manufacturers to produce high-quality Pantoprazole Sodium Sesquihydrate at competitive prices. This cost-efficiency makes Indian manufacturers attractive to global pharmaceutical companies looking for affordable yet high-quality APIs.

2. Strict Regulatory Compliance

Indian pharmaceutical manufacturers adhere to stringent regulatory standards, such as Good Manufacturing Practices (GMP), which are set by various global regulatory authorities like the US FDA, EMA, and WHO. Compliance with these standards ensures that the APIs produced meet international safety and quality standards.

3. State-of-the-Art Manufacturing Facilities

India boasts state-of-the-art manufacturing facilities equipped with modern technologies, advanced reactors, and automated systems that help improve production efficiency and ensure consistency in product quality. These facilities are capable of producing large quantities of Pantoprazole Sodium Sesquihydrate without compromising quality.

4. Experienced Workforce

India has a skilled workforce with expertise in organic chemistry and pharmaceutical manufacturing. This expertise is essential in the production of complex and high-potency APIs like Pantoprazole Sodium Sesquihydrate. The workforce is well-trained in adhering to quality control procedures and ensuring compliance with international standards.

5. Strong Export Market

India is one of the leading exporters of pharmaceutical products globally, including Pantoprazole Sodium Sesquihydrate API. Indian manufacturers have established strong export channels, ensuring a consistent and reliable supply to pharmaceutical companies in Europe, North America, Africa, and Asia.

6. Customization and Flexibility

Indian manufacturers offer a high degree of flexibility and customization in their production processes. They can cater to specific customer requirements, including providing different batch sizes, packaging options, and private labeling services.

Top Pantoprazole Sodium Sesquihydrate API Manufacturers in India

Several leading pharmaceutical manufacturers in India specialize in the production of Pantoprazole Sodium Sesquihydrate API. These manufacturers maintain high standards of production, quality control, and regulatory compliance to ensure the supply of premium-quality APIs.

KekulePharma

KekulePharma is a prominent name in the Indian pharmaceutical API manufacturing sector. The company has expertise in the production of high-quality APIs, including Pantoprazole Sodium Sesquihydrate. KekulePharma follows stringent GMP standards and has a reputation for producing high-potency APIs with superior purity and stability. Their commitment to product quality and regulatory compliance makes them a preferred supplier of Pantoprazole Sodium Sesquihydrate globally.

Aurobindo Pharma

Aurobindo Pharma is a well-established pharmaceutical manufacturer with a global presence. The company produces Pantoprazole Sodium Sesquihydrate API in large quantities and exports it worldwide. Aurobindo Pharma is known for its high-quality products, and it adheres to international regulatory standards, including US FDA and EMA certifications.

Hetero Drugs

Hetero Drugs is another major manufacturer of Pantoprazole Sodium Sesquihydrate API in India. With its state-of-the-art facilities and robust quality control measures, Hetero Drugs ensures the production of high-quality APIs that meet the needs of pharmaceutical companies globally. The company has a strong export presence and is a trusted supplier in the pharmaceutical industry.

Pantoprazole Sodium Sesquihydrate (CAS number 138786-67-1) is an essential active pharmaceutical ingredient widely used in the treatment of acid-related gastrointestinal disorders. India has become a global leader in the production and supply of Pantoprazole Sodium Sesquihydrate API due to its cost-effective manufacturing processes, advanced production facilities, and adherence to stringent regulatory standards. Companies like KekulePharma, Aurobindo Pharma, and Hetero Drugs are major players in this field, ensuring the consistent supply of high-quality APIs to meet the growing global demand.

As the demand for Pantoprazole continues to rise, India remains a top choice for sourcing this vital API due to its expertise, quality assurance, and competitive pricing. Whether you're a pharmaceutical company looking for a reliable supplier or seeking to understand the complexities of API manufacturing, India continues to be the hub for Pantoprazole Sodium Sesquihydrate production.