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Megafine, established in 1995, is a privately owned and professionally managed enterprise with it’s corporate office in Mumbai and two multipurpose manufacturing sites at Vapi & Nashik in India, Vapi facility being successfully inspected by US-FDA and the Nashik facility is being approved by BGVFHH Germany (EMA EU-GMP), Japan PMDA, Health Canada, TGA Australia, COFEPRIS Mexico & Korea MFDS. Both the plants are also certified by WHO GMP, ISO 9001:2008, 14001:2004 & OHSAS 18001:2007 and have been audited by several Innovators and leading Generic companies from time to time.
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Uquifa is the API division of Vivimed Labs. Uquifa is a manufacturer of Active Pharmaceutical Ingredients (APIs) and intermediates for the pharmaceutical Industry. Operates 3 manufacturing sites, 2 in Spain and 1 in Mexico, which operates under cGMP conditions and has been inspected and approved by major Pharmaceutical Companies and Regulatory Authorities, including the US FDA. Uquifa sells to more than 70 countries worldwide and has more than 150 active DMF´s filed and 26 COS approved. Uquifa counts amongst its customers the major Generic and Ethical companies operating in the Industry and continues to invest in personnel and facilities to maintain a strong technology offering to both, the Generic Industry and the Ethical Pharmaceutical Industry. In addition to our stable generic portfolio, UQUIFA works as CMO, developing and producing Toll Manufacture and Custom Synthesis giving assistant to your business. Fulfilling regulatory and quality requirements to ensure your product is produced in in the same way as if you perform internally.
- Frontage Laboratories
- Hansyn Pharma
- LGM Pharma
- Shenzhen Zhijun Pharma
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API, active pharmaceutical ingredient is key spend line item for pharmaceutical companies. In order to have strategic alliance with right vendor, one should evaluate API manufacturing experience that each vendor carries. Best way to check API mfg strength of potential strategic vendors is by evaluating their US DMF count. Below is the list of top 10 US DMF holders in Type II category.
Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
|Company||US DMF Count|
|TEVA or TAPI||311 ( website says 370 APIs )|
|MSN||266 ( website says 152 APIs )|
|AUROBINDO PHARMA||215 (SEC filings states 220 APIs)|
|MYLAN||213 ( website says 250 APIs )|
|DR REDDY||205 ( website says 450 + globally)|
As expected, market was led by TAPI which holds close to 311 DMFs under Type II DMF category, followed by MSN, Aurobindo, Mylan & Dr Reddy.
Below are some important points from analysis:
- Total of 10243 active DMF count were recorded in Type II DMF category.
- Top 12 players accounted for ~23% of overall DMF count, with more than quarter of this 23% coming from Teva and MSN alone.
- Only 5 companies accounted for greater than 2% of DMF count share, and included likes of Dr Reddy, Aurobindo Pharma, Mylan and two mentioned in above point.
DMF count might appear as just another number but it is one of the most important KPI to understand vendor’s technical know-how. Hence, the above mentioned vendors if part of your incumbent list, should be retained as is, and must be transitioned to strategic vendors going forward. If otherwise, these suppliers must be positioned in your preferred partner list, probably for future consignments mapped to large volumes.
Source 1 : http://www.msnlabs.com/api-dmfs.html
Source 2 : http://www.aurobindo.com/docs/press-room/press-reports/aurobindo-pharma-ltd-q4-fy-16-17-and-fy-1617-press-release.pdf
Source 3 : https://www.tapi.com/ProductCatalog.pdf?v=812
Two best innovators join hand to deal with age related health issues. With close to 24 early stage developments – which are on their way to commercialisation, the duo are likely to change the face of healthcare in coming days. Below is news release from Calico’s website:
– Extension builds on collaboration established in 2014
– Collaboration focuses on aging and age-related diseases, including neurodegeneration and cancer
AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, and Calico, a company focused on aging research and therapeutics, today announced an extension of their collaboration to discover, develop and bring to market new therapies for patients with age-related diseases, including neurodegeneration and cancer.
Calico is the Alphabet-backed life sciences company that is led by former Genentech chairman and CEO Arthur D. Levinson, Ph.D. With more than 150 employees, Calico has established a world-class research and development facility in the San Francisco Bay Area.
Working together with AbbVie, Calico pursues discovery-stage research and development. AbbVie provides scientific and clinical development support and will lend its commercial expertise to lead future development and commercialization activities. Since 2014, the collaboration between the two companies has produced more than two dozen early-stage programs addressing disease states across oncology and neuroscience and yielded new insights into the biology of aging.
“We’ve built a successful collaboration – both scientifically and culturally – that is advancing cutting-edge science,” said Michael Severino, M.D., executive vice president, research and development, chief scientific officer, AbbVie. “Calico has attracted an outstanding team of world-class scientists and the extension of this collaboration allows us to further build on the research we’ve done to identify transformative treatment options for patients with age-related diseases.”
“Our collaboration with AbbVie has fully met our high expectations,” said Dr. Levinson. “Our initial agreement created a unique partnership and this extension will accelerate further our efforts to understand the science of aging to advance novel therapies for patients.”
Under the terms of the agreement, the collaboration between the two companies is now extended for an additional three years. Calico will be responsible for research and early development until 2022 and will advance collaboration projects through Phase 2a through 2027. AbbVie will continue to support Calico in its early R&D efforts and, following completion of Phase 2a studies, will have the option to manage late-stage development and commercial activities. Both parties will share costs and profits equally. AbbVie and Calico will each commit to contribute an additional $500 million to the collaboration.
Thermo Fisher Scientific Inc., one of the world’s top life science company opens it U.S. Precision Medicine Science Center (PMSC) in Cambridge, Mass.
This facility beholds technologies that addresses collaborators need of analytical workflows which can generate precise molecular profiles of patients. This data will ultimately complement collaborators quest to treat disease effectively in clinical set-ups.
The centre also houses best in class experts who can help current and potential clients expedite journey from biomarker discovery to assay development. Company intends to achieve this by compressing R&D timelines.
“For health and science innovators, a bottleneck exists today between the discovery of biomarkers and their widespread use at the point of care,” said Emily Chen, senior director, Thermo Fisher Precision Medicine Science Center. “Our goal at the PMSC is to remove that bottleneck and help scientists and physicians reduce the time it takes to demonstrate clinic validity and utility.”
“Precision medicine needs to be based on high-quality data, and proteomics is central to that,” said PMSC collaborator Jennifer Van Eyk, PhD, Cedars-Sinai Medical Center in Los Angeles. “Our work with the team at the PMSC is helping us accelerate the important journey from discovery to patient care.”
This is not first time that company has opened PMSC centre, Thermofisher in past has opened similar centre in China that looks to address same challenges.
This 20 billion dollar sales company has unique blend of services that range from life science research to patient diagnostics, stretching far beyond to laboratory offerings. It is this combination that has positioned the company to forefront of innovation, which is well reflected in its global strategic decisions. For more updates on Thermo fisher and its peers, follow Pharmed Intel.