HPAPI
Scintel Pharmachem Pvt Ltd has special capabilities in high value-added areas of pharmaceutical development and manufacturing, including High Potency Manufacturing.
Prostaglandins and other highly potent compounds like low volume hormones, steroids and oncology products present a number of potential challenges in their development, production and handling. SPPL has extensive experience in the cGMP production of these types of compounds, from grams to hundreds of kilograms per year.
Facility & Equipment
- Expertise in handling high potency, controlled and generic substances
- Experienced staff dedicated to cGMP synthesis
- Production capacities of facilities ranging from gram-scale through hundreds of Kg.
- Dedicated non-GMP and GMP high-potency areas
- Walk-in hoods and a pilot plant
- Facilities engineered to the most stringent standards for safety, material handling, process control, and efficiency
- Excellent FDA Compliance
- -78° C to 250° C, variety of glass, steel and alloy reactors
- Cryogenic chillers (up to -80°)
- Rotary evaporators
- Reactors ranging from 1Ltr to 500Ltr
- Experience at using reactive & hazardous reagents
- Inaccessible, flexible and well-equipped suite dedicated to small scale manufacturing
- Large-scale preparative chromatography
- Flash Chromatography
- Full-fledged Analytical facility equipped with all modern 21CFR equipments
List of High Potent APIs
| S. No | API Name | Therapeutic area | CAS No. | Chemical Name | Regulatory Status |
|---|---|---|---|---|---|
| 1 | Misoprostol 1% HPMC | MTP/PPH | 59122-46-2 | Prost-13-en-1-oicacid,11,16-dihydroxy-16-methyl-9-oxo-,methylester,(11alpha,13E)-(±) | Tech Pack Available |
| 2 | Mifepristone | MTP | 84371-65-3 | 11β-(4-Dimethylamino)phenyl-17β-hydroxy-17-(1-propynyl)estra-4,9-dien-3-one | Tech Pack Available |
| 3 | Bimatoprost | Anti-Glaucoma | 155206-00-1 | (5Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-[(1E,3S)-3-hydroxy-5-phenyl-1-penten-1-yl]cyclopentyl]-N-ethyl-5-heptenamide | Tech Pack Available |
| 4 | Travoprost | Anti-Glaucoma | 157283-68-6 | Isopropyl (Z)-7-((1R,2R,3R,5S)-3,5-dihydroxy-2-((R,E)-3-hydroxy-4-(3-(trifluoromethyl)phenoxy)but-1-en-1-yl)cyclopentyl)hept-5-enoate | Tech Pack Available |
| 5 | Latanoprost | Anti-Glaucoma | 130209-82-4 | (5Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-[(3R)-3-hydroxy-5-phenylpentyl]cyclopentyl]-5-heptenoic Acid 1-Methylethyl Ester | Tech Pack Available |
| 6 | Treprostinil | Anti- Hypertensive | 81846-19-7 | Acetic acid,2-[[(1R,2R,3aS,9aS)-2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl]oxy] | Tech Pack Available |