Maithri Drugs Private Limited, a leading pharmaceutical API manufacturer based in India, has announced the successful filing of its 74th and 73rd US Drug Master Files (USDMFs) with the U.S. Food and Drug Administration (USFDA), further expanding its footprint in global regulated markets.
The newly filed DMFs include:
- 74th USDMF – Daridorexant Hydrochloride (USDMF #042355)
- 73rd USDMF – Magnesium Sulfate Dried USP (USDMF #042236)
These submissions reflect Maithri’s ongoing commitment to quality, regulatory compliance, and therapeutic innovation in Active Pharmaceutical Ingredient (API) development.
Daridorexant Hydrochloride: A Next-Gen Insomnia Treatment API
Daridorexant Hydrochloride is a dual orexin receptor antagonist (DORA) indicated for the treatment of insomnia in adults. Unlike conventional sedatives, it targets the orexin system, helping patients fall asleep and stay asleep without significantly disrupting REM or deep sleep phases.
Therapeutic Highlights:
- Improves both sleep initiation and maintenance
- Reduced risk of next-day sedation compared to traditional hypnotics
- Low abuse potential (classified as Schedule IV in the U.S.)
Formulation: Oral tablets in 25 mg and 50 mg doses, administered once nightly within 30 minutes before bedtime.
Magnesium Sulfate Dried USP: A Critical Care Essential
Magnesium Sulfate is a vital electrolyte therapy widely used in emergency and maternal healthcare. The dried form enhances its utility in injectable preparations.
Key Indications:
- Severe Hypomagnesemia: For rapid correction of magnesium deficiency
- Eclampsia and Pre-eclampsia: First-line IV therapy to prevent seizures in pregnant women
- Torsades de Pointes: Life-saving intervention in cardiac arrhythmias
- Severe Asthma: Occasionally used as adjunct IV therapy for refractory bronchospasm
Available Forms: Dried powder for IV/IM reconstitution; also available as oral granules in specific cases.
Driving Regulatory Excellence
Maithri Drugs’ continued USDMF filings position the company as a trusted supplier to global pharmaceutical firms, particularly in regulated markets like the U.S., Europe, and Japan.
“Our 74th and 73rd USDMF filings mark another strong step forward in delivering world-class API solutions backed by rigorous regulatory standards and scientific innovation,” said a company spokesperson.
Maithri Drugs continues to invest in R&D, compliance infrastructure, and sustainable manufacturing practices to support a growing portfolio of high-value APIs across therapeutic segments.
About Maithri Drugs:
Maithri Drugs Private Limited is a Hyderabad-based pharmaceutical company specializing in the development and manufacture of Active Pharmaceutical Ingredients (APIs). With a growing number of USDMFs and a global client base, the company is a significant contributor to the generic pharmaceutical supply chain.
