DMF GRADE API MANUFACTURER EXPORTER SUPPLIER SWAPNROOP DRUGS AND PHARMACEUTICALS MAHARASHTRA INDIA

  Q1: What are the regulatory certifications and compliance standards followed for KETOPROFEN SODIUM STERILE by Swapnroop Drugs and Pharmaceuticals? 🏥📋🔬 Swapnroop Drugs and Pharmaceuticals ensures that KETOPROFEN SODIUM STERILE complies with international regulatory and quality standards to support global supply and regulatory filings. Here’s a detailed breakdown of the typical regulatory certifications and compliance measures followed: 🏢 1. GMP (Good Manufacturing Practices) Certification Complies with WHO-GMP , and possibly EU-GMP or US FDA cGMP depending on market. Ensures aseptic manufacturing under sterile conditions. 🧴🧪 Facilities inspected for compliance with Schedule M under Indian regulations. 📑 2. ISO Certifications Likely holds ISO 9001:2015 for quality management systems. May also be certified for ISO 14001 (Environmental) and ISO 45001 (Occupational Health & Safety) 🌱⚠️ 🧬 3. Regulatory Filings & Documentation Drug...

  What is ARTEETHER API manufactured by Swapnroop Drugs & Pharmaceuticals? ​ ARTEETHER API is a semi-synthetic derivative of artemisinin, derived from the plant Artemisia annua , and is primarily used for treating severe and chloroquine-resistant Plasmodium falciparum malaria, including cerebral malaria 🏭 About Swapnroop Drugs & Pharmaceuticals Swapnroop Drugs & Pharmaceuticals, established in 2013 and based in Aurangabad, Maharashtra, is an ISO 9001:2008 and FDA-approved pharmaceutical company. They specialize in the sales and marketing of Active Pharmaceutical Ingredients (APIs), intermediates, herbal extracts, and pharmaceutical formulations. Their product portfolio includes over 500 molecules catering to various therapeutic areas such as anti-infectives, cardiovascular, CNS, gastrointestinal, and more ⚗️ About Arteether API Arteether is a fast-acting blood schizonticide effective against the erythrocytic stages of malaria parasites. It is indicated as a se...