Active Pharma Ingredients (APIs)
JPN Pharma is a global leader in the production of large-volume generic Active Pharmaceutical Ingredients (APIs), committed to upholding environmental safety and sustainability at every stage. Our facilities boast prestigious EDQM (European Directorate for the Quality of Medicines) and WHO-GMP (World Health Organization - Good Manufacturing Practices) approvals, underscoring our expertise in handling hazardous chemicals and executing complex reactions with meticulous precision. Supported by a dedicated R&D setup and stringent QA/QC practices, we ensure uncompromising quality across varied batch sizes and reactor volumes ranging from 5 to 8000 liters.
At JPN Pharma, sustainability is ingrained in our operational ethos. We employ environmentally responsible production methods and prioritize the use of clean fuel in our boiler operations. Our advanced equipment includes the Agitated Nutsche Filter Dryer (ANFD) and Rotary Vacuum Paddle Dryer, enabling safe and efficient production, particularly for temperature-sensitive products. Managed by JPN LLP, our Zero Liquid Discharge facility exemplifies our commitment to minimizing environmental impact.
Trusted by esteemed pharmaceutical leaders like Cipla, Glenmark, Zydus, and Abbott, JPN Pharma specializes in manufacturing APIs on a significant scale. Situated in Maharashtra, our GMP and FDA-approved facilities are dedicated to producing essential molecules that play a pivotal role in global healthcare solutions.
Our APIs are used across various therapeutic categories, including:
Topical antimicrobials
Cardiovascular treatments
Hypertension and heart failure management
Bone health
Benign prostatic hyperplasia
Anticonvulsants
Dementia care
JPN Pharma continues to lead the industry with a steadfast commitment to
quality, sustainability and innovation.
Name of Product :- Memantine Hydrochloride |
DMF |
SR. NO. | CRITERIA | SPECIFICATION |
1 | Description | White to off-white, coloured powder |
2 | Solubility | Slightly soluble in water. |
3 | Identification A) Infrared absorption Spectrophotometry |
|
B) By GC | B) The retention time of the major peak of the sample solution corresponds to that of the standard solution, as obtained in the Assay | |
C) Chloride test | C) Meets the requirements | |
4 | Assay (By GC) | Not less than 98.0% and not more than 102.0% (anhydrous basis) |
5 | Residue on ignition | Not more than 0.1% |
6 | Organic impurities (By GC) Memantine related compound A Memantine related compound B Memantine related compound C Memantine related compound D Memantine related compound E Any individual unspecified impurity | Not more than 0.15% Not more than 0.15% Not more than 0.15% Not more than 0.15% Not more than 0.15% Not more than 0.10% |
7 | Water content | Not more than 1.0% |
Additional test | ||
8 | Residual Solvent (By GCHS) Acetonitrile Benzene Toluene Dichloromethane Isopropyl alcohol |
Not more than 2 ppm Not more than 890 ppm Not more than 600 ppm Not more than 5000 ppm |
