Are you seeking world-class API solutions for your pharmaceutical manufacturing needs? Maithri Drugs Private Limited is proud to announce a major regulatory accomplishment—the successful submission of our 76th United States Drug Master File (USDMF No. 042693) for Dibasic Potassium Phosphate USP (K₂HPO₄). This milestone is a reflection of our unwavering dedication to quality, compliance, and advancing global patient care.
Contents
- 1 Empowering Pharma Excellence Since 2013
- 2 Spotlight on Dibasic Potassium Phosphate USP (K₂HPO₄)
- 3 Clinical and Pharmaceutical Applications
- 4 Product Advantages and Manufacturing Strength
- 5 Regulatory Significance of the USDMF Milestone
- 6 Our Commitment to Partners and Patients
- 7 Join the Maithri Network
Empowering Pharma Excellence Since 2013
Founded in 2013 in Hyderabad’s industrial heartland, Maithri Drugs has rapidly risen to prominence as a leader in active pharmaceutical ingredient (API) manufacturing. Our mission is to bridge the gap in supply chains by providing reliable, high-quality APIs to the world’s top pharmaceutical companies.
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With over 75 DMFs filed—each representing a new benchmark in regulatory success—Maithri has become synonymous with API innovation and dependability.
Our facility is USFDA-audited, cGMP-certified, and guided by a relentless focus on sustainability and research-driven growth. Trusted by partners across therapeutic areas like oncology, cardiology, and metabolic medicine, Maithri’s robust quality and operational agility are our hallmarks.
Our leadership is reflected in our strong CRISIL rating (BBB/Stable/A3+) and a dynamic team passionate about raising industry standards.
Spotlight on Dibasic Potassium Phosphate USP (K₂HPO₄)
Dibasic Potassium Phosphate USP (CAS No. 7758-11-4) is a versatile, pharmacopeia-grade inorganic salt that serves as a dual source of vital minerals: potassium and phosphorus. Delivered as a highly soluble white powder, it is a key ingredient in injectable/solution dosage forms—tailor-made for intravenous (IV) administration in clinical and hospital settings.
Clinical and Pharmaceutical Applications
- Critical Care & ICU: Central in Potassium Phosphates Injection, used to treat hypophosphatemia—a condition commonly seen in 2–3% of hospitalized and up to 80% of ICU patients.
- Parenteral Nutrition: Essential for patients unable to absorb nutrition orally, supporting phosphorus and potassium balance for improved recovery and wound healing.
- pH Stabilization: Acts as an effective buffering agent in IV formulations, maintaining acid-base equilibrium and aiding calcium homeostasis.
- Rehydration & Electrolyte Restoration: Integral in oral and IV fluids for rapid rehydration therapy during dehydration, burns, sepsis, or post-operative care.
- Renal and Cardiology Support: Supports safe kidney function and reduces risk of metabolic imbalances, helping stabilize heart rhythm through potassium replenishment.
Product Advantages and Manufacturing Strength
- Produced under strict cGMP and USFDA guidelines for supreme purity (>99%) and batch-to-batch consistency.
- Low endotoxin levels and excellent solubility ensure safe and reliable IV administration, minimizing formulation risks and maximizing patient safety.
- Comprehensive technical assistance, including stability studies and formulation advice, empowers our clients from product development to global commercialization.
- Eco-conscious manufacturing and a strong ESG ethos, including waste reduction and green synthesis initiatives, cement Maithri as a future-facing API producer.
Regulatory Significance of the USDMF Milestone
Submitting a USDMF to the FDA goes beyond compliance—it establishes Maithri Drugs as a trusted technical partner for ANDA, NDA, and IND holders in the U.S. pharma market.
The DMF provides confidential, detailed insights into the product’s chemistry, manufacturing, and quality controls, allowing our partners to reference regulatory data seamlessly during drug approvals while protecting our intellectual property. Each DMF strengthens supply chain resilience and accelerates the launch of critical therapies that impact patient lives globally.
Our Commitment to Partners and Patients
Maithri’s journey is defined by resilience, innovation, and an unwavering passion for quality. This 76th USDMF is not just a number—it’s a promise to our valued clients, healthcare professionals, and the communities they serve. We express our deepest gratitude to our dedicated teams, partners, and technical experts whose hard work enabled this achievement.
Join the Maithri Network
With a rapidly growing online community of over 6,000 LinkedIn followers and trusted partners worldwide, Maithri Drugs invites you to explore collaboration opportunities in electrolytes, critical care APIs, and beyond.
- Contact us: www.maithridrugs.com | info@maithridrugs.com
- Follow our latest updates: Maithri Drugs LinkedIn Page
- Share your thoughts and connect with innovators dedicated to improving global healthcare.
Experience pharma leadership, innovation, and trust—partner with Maithri Drugs for your API needs and empower the medicines of tomorrow.
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