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Committed to the future of Dermatology

Research & Development

We have built our business model based on futuristic innovation. Our Early investmentsin R&D, beginning two decades ago, enabled us to make technology our key differentiator and develop a basket of robust products for diverse markets across the world. Our core strength lies in our ability to excel in developing technologically complex products through focused teams in formulations, process chemistry and analytical development. We have the capability to deliver quality products within established timelines based on clinical evidence.

We have around 1200 research scientists working in multiple R&D centers acrossthe globe equipped with cutting-edge enabling technologies for research. Our scientists have expertise in developing difficult to make technology intensive products, Novel Drug Delivery Systems (NDDS) and New Chemical Entities (NCEs).

Our research scientists work closely with our business development team to develop and generate innovative concepts and ideas, exploiting both market needs and synergies across therapeutic areas. We are the leading healthcare company globally in terms of investment in R&D; we invest around 35 – 40 per cent of our revenues annually in research. Even as we focus on developing new technologies, we continuously monitor research efficiency. Our R&D productivity ranks among the highest for healthcare companies globally.

Our research strategy and implementation are well supported by a strong intellectual property team having expertise and experience in chemistry, analytical techniques, dosage forms and global patent law. Over the last more than 20 years, we have been able to get more than 6500 global research patents.Our researchers have published more than 2000 papers in all leading medical journals like NEJM, AJCD, JAMA, BJD, BMC, JAAD etc…

Our research capability has not only paid us rich dividends in terms of business, but also earned for us an enviable reputation for quality and capability.Sedge is an established name in GlobalHealthcare market for its innovative researched products. With its diversified Research & Development product portfolio, Sedge has gained leadership in various therapeutic segments.

Our all 6 R&D centers have been audited and approved by international regulatory authorities, including the US FDA, European authorities.

Manufacturing

 

We have ensured world-class quality in design, equipment and operations in all our manufacturing facilities across the world. We have over 8 (Finished dose) state-of-the-art manufacturing sites. These manufacturing units are located in Canada, Poland, India, Brazil, Mexico, Nigeria, South Africa and Romania. Our units ensure that we are able to provide best-in-class products to patients across more than 120 countries worldwide.

We have a highly skilled team of regulatory affairs specialists who are well versed with regulatory policies and procedures around the world. They have a wealth of experience in the timely filing of dossiers as well as handling regulatory queries from both authorities and customers.

A wide range of regulatory agencies routinely conduct stringent audits of our manufacturing facilities for compliance with Current Good Manufacturing Practices (cGMP). Several regulatory agencies, including FDA-USA, EMA-Europe, MHRA-UK, MCC-South Africa, TGA-Australia, ANVISA-Brazil, WHO-Geneva, BfArM-Germany, KFDA-Korea and PMDA-Japan, have inspected our facilities.

Quality

 

If there is one attribute to which we attach the utmost importance it is quality. Quality is considered paramount at all locations where we conduct regulated research, development, manufacture, testing and distribution of pharmaceutical products. Our operations are driven by best-in-class technology and processes, abiding by all major stringent regulatory approvals. Our commitment to implementing a robust global quality management system is based on our determination to sustain a culture of operational excellence, meeting and exceeding the expectations of all stakeholders, including patients, customers and regulators. Thus, our passion for quality goes beyond business and statutory requirements. Putting patients first is our motto.

Our global Quality Management Team ensures that every product manufactured and distributed by us complies with all internationally accepted good practices and standards of quality, purity, efficacy and safety.

To maintain quality standards, every plant has well defined procedures and systems in place in compliance with the requirements of the Current Good Manufacturing Practices (cGMP), WHO, PIC’s and EU GMP in order to ensure that our operating procedures meet the very exacting standards of regulators like the US FDA, EMA, HC, WHO and TGA, among others.

Each site has well trained personnel for quality control along with a regulatory affairs department ensuring strict adherence to quality systems and procedures. The teams are guided by a Corporate Quality Unit (CQU). CQU ensures that the latest updates in GMP are being translated into guidelines, standard operating procedures (SOPs) and protocols. The teams ensure that these guidelines are implemented to deliver quality products time after time. In addition, the manufacturing plants are audited by an autonomous Corporate Compliance Department with a view to ensuring 24 x 7 compliance and conformance.

Our unwavering commitment to quality goes beyond ourselves. We insist that our business partners comply with international regulatory and business standards which are in alignment with those of our own. Our own quality standards are constantly benchmarked against global best practices. This means that these are constantly upgraded to keep pace with the evolving dynamics of the global environment.

We remain committed to the highest levels of quality and will ensure that all our facilities, offices and legal entities continue to meet the exemplary standards that are expected of a global pharmaceutical company.

10
Offices
Worldwide
10
Refineries &
Operations
6000
Satisfied
Employees
22
Awards &
Recognitions

Partnerships

Sedge is a leading pharmaceutical company focused exclusively on dermatology. For over many years, the Company has harnessed insights of scientific discovery to develop innovative dermatology solutions for patients and physicians. Our dedicated staff, valued partnerships, scientific leadership and good luck have brought us great success. To further that success, dermatology company Sedge is engaged in active outreach to the best scientific organizations worldwide. Because we embrace the best ideas in science, building effective collaborations of all kinds – from early stage development to late stage licensing – is a priority for Sedge.

The Company forms licensing partnerships around innovative product candidates and technologies. Sedge is most interested in opportunities that have a well-validated target, a novel mechanism of action, well-characterized pharmaceutical properties, a strong intellectual property position and preclinical or clinical data. Dermatology company Sedge’s technology licensing agreements must be science driven, provide access to technology that extends our existing programs and are consistent with our research strategies.

Want to be our Partner?

We are constantly searching for new partners and Distributors, CNF Agents and Channel Partners. Feel free to contact us.