APDM Pharma: Your Trusted Partner in Drug Development and Manufacturing Services
"APDM Pharma is your reliable and competent partner offering drug development and manufacturing services globally. Our mission is to provide top pharmaceutical solutions, and our experienced team ensures high-quality services. With a focus on oral solids, sterile products, oral liquids, and more, we offer a wide range of pharmaceutical formulations, product development, and manufacturing support. Contact us for seamless project transfer, regulatory assistance, and quality support."
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CORPORATE PROFILE APDM PHARMA; YOUR RELIABLE AND COMPETENT PARTNER IN DRUG DEVELOPMENT AND MANUFACTURING SERVICES
MISSION AND VISION MISSION : ONE STOP VALUE ADDED PHARMACEUTIAL SOLUTION FOR GLOBAL PHARMACEUTICAL COMPANIES . VISION : TO ACHIEVE OUR MISSION TO BE TOP GLOBAL PHARMACEUTICAL SOLUTION PROVIDERTHROUGH OUR QUALIFICATION, EXPERIENCE AND EXPOSURE.
FOUNDER : Mr Jayanta Kumar Mandal is a Formulation Scientist with 29 Y experience in R&D, Patents, pK Expertise. He worked in Top pharma companies in India for Regulated & ROW markets on OSD, Parenteral, Topical, Ophthalmic dosage forms of ANDA & NDA. He is an entrepreneur with one successful scaling up of a CDO in 7 years time and a CDMO in incubation stage. Mrs. Jaishree Sharma : She is a pharmaceutical professional with over 18 years of formulation and pharmacokinetics expertise in the field of Biopharmaceutics and Pharmacokinetics. She has expertise in various dosage forms including complex generics which includes all sorts of Oral Dosage Form, Injectable, Orally Inhaled and Nasal Drug Products, Transdermal Patches etc. ( For ANDAs and 505b(2)s )She is skilled in pharmacokinetics, biopharmaceutics, BA/BE, IVIVC and evaluation of molecules under development in multiple therapeutic areas utilizing in-silico tools for IVIVC/IVIVR. Expert in executing In Vitro Permeation study for Oral Dosage form. Mrs. Mousumi Mandal : She is a passionate professional on operation, HR and Finance Mr. Shashank Patel, Operation Head is another industry stalwart at APDM with 38 Y experience in R&D and Manufacturing Operations on various dosage forms & technologies.
OUR FACILITIES AND TEAM OUR FACILITIES : - CORPORATE OFFICE IN THE CITY 403 Patron Building, Rajpath Rangoli Road, Behind Rajpath Club; Satellite, Ahmedabad 380054, Gujarat, India - R&D site : Plot 90 & 91, Parishram Industrial Estate , Sarkhej Bavla Road, Changodar, Ta: Sanand; Ahmedabad, Gujarat, India - Manufacturing Site : APDM Pharmaceuticals Pvt Ltd, Vill: Sakodara, Bavla Ganeshpura Highway;Ta: Bavla, Ahmedabad, Gujarat India OUR Team : A team of well qualified project management, QA. Engg and manufacturing, Formulation Development, Analytical Development are in place.
SERVICES OFFERED Pharmaceutical Formulations Solid Oral dosage forms ( Tablets, Pellets, MUPS ) sterile technologies Oral Liquids ( solutions and suspensions) semi solids Development and technology services Drug product development Contract Manufacturing and supply Site transfer of projects for commercial viability Gap analysis and execution for transfer/use of MA to other geographical markets. Analytical development | Regulatory support | Quality support PRODUCTS: ORAL SOLIDS | STERILE | ORAL LIQUID | TOPICAL |
SERVICES OFFERED ( CONTD.) QA SUPPORT : - Vendor audits. - Compliance support for regulatory and client QA audits. - Back up support for manufacturing plant QA, QC and QMS for API and FDF manufacturing plants as per most recent regulatory requirement . - Gap analysis and support for compliances for expansion to new markets. REGULATORY SUPPORT : - DOSSIER ( ECTD,CTD )compilation as per USFDA, EMEA. CANADA and other countries. - Support for CMC ,QA and BA BE/CT queries.
APDM STRENGTHS Sourcing to delivery of product and services to suit your need. Exposure and experience in generics, 505(B)2 and new formulations. Patent understanding, protection and non infringing. Reliability and confidence. Non compete with clients at all levels. In house manufacturing of oral solids and vast networks of reliable and efficient CMO across the globe. Track record of faster turn around time.
EQUIPMENT LIST OF FORMULATION AND DEVELOPMENT LAB EXPETED MACHINES IN NEAR FUTURE 1. Lyophilizer 2. High pressure homogenizer 3. Roller compactor 1. RMG - 25 LTR 2. Table Top Dryer 3. Fluid Bed Processor 4. Co Mill 5. Double Cone Mixer 6. Vibro Sifter 12" 7. Planetary mixer with horizontal main drive 8. Compression Machine 9. Auto Coater with 5", 8", 10", 12" 10. Exhaust Blower system for Autocoater & FBP 11. Single Screw Extruder 12. Spheronizer 13. Capsule Filling Machine 14. Semi Auto Blister Machine with one PVC-ALU C/P 15. Semi Auto Blister Extra C/P for ALU-ALU Blister 16. Induction cap sealing machine 17. High Speed Homogenizer
EQUPMENT LIST OF ANALYTICAL DEVELOPMENT 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. Stability Chamber (25 0C/60%) 11. Stability Chamber (30 0C/65%) 12. Stability Chamber (30 0C/75%) 13. Stability Chamber (2-8 0C) 14. Stability Chamber Photo 200 Ltr 15. Hot Air Oven 16. Spot Extractor 17. Electronic Weighing Balance 18. Hardness Tester 19. Tablet DT Apparatus 20. Friability Test Apparatus 21. Leak Test Apparatus 22. Tap Density Tester 23. Sieve Shaker 24. pH Meter 25. Sonicator 26. Fume Hood Gas Chromatography (Head Space) HPLC with UV Detector HPLC with PDA Detector Tablet Dissolution Apparatus 8L with DC Collector Tablet Dissolution Apparatus 14L with DC Collector Karl Fischer Apparatus Potentiometric Titrator UV Spectrophotometer Stability Chamber (40 0C/75%) EXPETED MACHINES IN NEAR FUTURE 1. FTIR 2. Particle Size Analyzer
