Product Description
Active Pharmaceutical Ingredients
We Saintroy Life science established in 2016 in hub of Pharmaceutical products ,Gujarat ,India.We offers all types of Active Pharmaceutical Ingredients from Surat.We also support all types of documents like COA, DMF with WHOGMP/EUGMP certified manufacturer at affordable rates .Providing quality and on time delivery is our company's basic moto.
Stringent Quality AssuranceEach Active Pharmaceutical Ingredient is rigorously tested to comply with ICH guidelines for residual solvents and pharmacopeial limits for microbial content and endotoxins. High-performance techniques such as IR and HPLC ensure reliable identification and quality. Standard testing also covers specific rotation, water content, heavy metals, and related substances, guaranteeing safe and consistent use in medicinal applications.
Versatile Manufacturing MethodsAPIs can be synthesized using traditional chemical reactions or produced via fermentation processes, depending on the nature of the ingredient. These controlled methods ensure consistent purity and structural integrity across every batch. With flexible production, we can cater to a range of pharmaceutical requirements, from small molecules to complex biologics.
Superior Packaging and StabilityAll APIs are packaged in HDPE drums with double liners or as specified per client requirements. This high-standard packaging preserves the chemical stability and physical quality of the powder, preventing contamination and degradation during transit and storage. When stored in cool, dry, well-ventilated environments, the shelf life ranges from two to five years, depending on the specific API.
FAQs of Active Pharmaceutical Ingredients:
Q: How are Active Pharmaceutical Ingredients tested for quality and compliance?
A: APIs are tested using state-of-the-art techniques such as Infrared Spectroscopy (IR), High-Performance Liquid Chromatography (HPLC), and methods specified in pharmacopeial monographs. These tests ensure the product meets standards for purity, potency, residual solvents, microbial limits, endotoxins, and other quality parameters.
Q: What are the recommended storage conditions for Active Pharmaceutical Ingredients?
A: APIs should be stored in a cool, dry, and well-ventilated area, ideally in tightly sealed containers such as HDPE drums with double liners. Proper storage ensures stability and maintains the shelf life, usually ranging from two to five years.
Q: When is the ideal time to use these APIs in pharmaceutical manufacturing?
A: These APIs are best used during the formulation and production phase of medicinal products. Timing depends on your manufacturing processes and batch requirements, ensuring the highest efficacy and integrity of finished pharmaceuticals.
Q: Where do you source and supply your Active Pharmaceutical Ingredients?
A: APIs are manufactured and supplied in India, catering to national and international markets as a dealer, distributor, exporter, manufacturer, supplier, trader, and wholesaler. Sourcing follows strict regulatory and quality protocols.
Q: What are the main benefits of choosing these pharmaceutical-grade APIs?
A: Key benefits include high purity (minimum 99%), compliance with international quality standards, extended shelf life, excellent microbial safety, and secure packaging. These APIs support consistent and safe drug production.
Q: How are the APIs packaged to prevent contamination or degradation?
A: APIs are securely packed in HDPE drums with double liners, minimizing exposure to environmental factors like moisture and contaminants. This packaging method preserves the physical and chemical stability of the product until final use.
Q: What is the manufacturing process for APIs and how is it chosen?
A: APIs are manufactured synthetically or by fermentation, determined by the compounds chemical nature and regulatory requirements. The selected method ensures optimal yield, purity, and compliance with pharmacopeial and ICH guidelines.