AGTC

Ajanta Pharma Limited (APL) is a pharmaceutical company headquartered in Mumbai, India. It has strong presence in Branded Generic business in India & Emerging markets; and Generic business in USA.

In India, company operates in selected therapeutic areas of Cardiology, Dermatology, Ophthalmology and Pain management. It's brands hold leadership positions in sub-therapeutic areas they are present in.

In Emerging Markets, company has presences in Africa, South East Asia, West Asia, and CIS on broader therapeutic segments such as anti-malarial, gastro, antibiotics, cardiology, dermatology, pain management, etc.

As on 31 March 2021, Ajanta has 36 ANDA approvals which are commercialised. And it is awaiting US FDA approval for 15 ANDAs. Company plans to file 10-12 ANDAs during the current financial year.

Company has state-of-the-art research facilities for formulation and API development located at Mumbai, India. R&D capabilities are evident from number of 1st to market products launched by the company providing patients most needed compliance and convenience. A dedicated and focused team of over 650+ scientists work for R&D, which is growing continuously.

Ajanta has 6 formulations manufacturing facilities located in India and 1 in Mauritius. Besides that, it also has an API manufacturing facility located at Waluj, India. Ajanta’s flagship formulation facilities at Paithan (Maharashtra, India) and Dahej (Gujarat, India) have been approved by US FDA.

Ajanta continuously invests in enhancing the existing manufacturing facilities to meet current cGMP requirements and also construct new facilities to meet company’s growth requirements.

Please visit http://ajantapharma.com/ for more information.

Drug Discovery Alliances is a provider of chemistry and formulation services bringing together scientific expertise and support during all stages of the R&D continuum for emerging biotechs, existing multinationals and the United States government. We provide a global service where our partners – located in N. America, China, Japan, Czech Republic, England, Germany and Italy – cover four key services:

Consulting
• CMC Project Management
• GMP Auditing
• Licensing
• Sourcing & Procurement

Drug Discovery
• Medicinal Chemistry

R&D/Pre-Clinical
• Analytical Method Development
• Catalysis Screening
• Crystallization
• Metabolites, Impurities ID & Synthesis
• Process Research
• Reference Standards
• Solid Form Capabilities

Manufacturing (Phase I-III)
• Advanced Intermediate Manufacturing
• API & Commercial Manufacturing
• cGMP Manufacturing
• Final Drug Product Manufacturing
• Formulation Development
• Quality and Regulatory Support
• Raw Material Manufacturing

Chemistry Technology Platforms
Aseptic Fill & Finish
• Chlorination
• Chromatography
• Cryogenic
• Distillation
• Fermentation
• Heck Reactions
• HPAPI / High Potency
• High Pressure
• High Temperature
• High Throughput / High Resolution X-ray Diffraction
• Hydrogenation
• Lyophilization
• Nitration
• Pastillation
• Phosgenation
• Polymorph Screening
• Powder Filling
• X-ray Crystallography

Project Examples
• 4 year program for development of Regulatory Starting Material supporting NDA filing for a neurology product
• Urgent API consulting for Clinical Phase III with supplier change and identified savings of $10M
• CMC project consulting on pre-IND candidates ($760M) for a CNS product licensed by Astellas
• Generic new formulation consulting supporting Clinical Phase III for 505(b)(2) for hypertension product
• Commercial API manufacture for ophthalmology product sourcing key suppliers leading to successful FDA approval
• Phase III API for antibody conjugate for oncology identifying key supplier

Intas is one of the leading multinational pharmaceutical formulation development, manufacturing and marketing companies in the world. It has been growing at about 25.5% CAGR over the last 5 years and crossed the $1.9 billion mark in the past financial year. The company has set up a network of subsidiaries, under the name Accord Healthcare in EU, US, Canada, SA, Australia, APAC as well as CIS & MENA regions. Intas is present in 85+ countries, with more than 69% of its revenue coming from global business.

Currently ranked 9th in the Indian pharmaceutical market, it’s the largest privately owned Indian generic pharma company. Intas has established leadership in key therapeutic segments like CNS, Cardio, Diabeto, Gastro, Urology and Oncology in India. It is also known for its range of products in other hospital-based therapeutic segments in the EU and US.

Intas operates 15 formulation, R&D and distribution facilities, of which 10 are in India, and the rest in the UK and Mexico. Between them, the facilities are accredited by global regulators such as USFDA, EMA, MHRA, TGA, and others. The company invests ~6-7% of its revenues in R&D and has over 10,000 product registrations worldwide with a strategic pipeline of 300+ high-value FTF/FTM, Biosimilars and NDDS products.

Intas' highly advanced EU-GMP Certified Biopharma division is fueled by a mission to provide affordable “biosimilars for billions” across niche segments such as oncology, auto-immune, ophthalmology, nephrology, rheumatology, and hormone-based therapies.

The Plasma Fractionation Unit of Intas Pharmaceuticals is a pioneer in manufacturing plasma derived therapeutics. It houses a full-fledged R&D lab and a state-of-the-art WHO-GMP certified manufacturing facility complemented with a GLP compliant QC lab.

Our values of Innovation, Customer Delight, Ownership & Collaboration, Performance Focus & Care for Society are the driving forces of our excellence.

Absorption Systems, a Pharmaron company, is a full-service nonclinical CRO developing innovative services and solutions for the pharmaceutical, biotech, medical device and regenerative medicine industry. Our services include research and testing for small molecules, large molecules, biologics, medical device and cell and gene therapy products. The company's mission is to continually develop innovative research tools that can be used to accurately predict human outcomes or to explain unanticipated outcomes when they occur. The company's facilities are strategically located in Philadelphia, San Diego, and Boston, servicing hundreds of customers throughout the world. Our focus is to maintain accuracy, timelines, and reliability at every stage of development. For more information on the company's comprehensive contract services and applied research programs, please visit absorption.com.

ACROSS is the first truly global, agile CRO alliance. Offering cost effective, cutting edge innovative solutions for small/medium pharmaceutical and biotech companies as well as public health institutes and non-governmental organizations, ACROSS is the latest player on the global field of clinical trials.

ACROSS Global is an entirely new business model, providing enhanced and innovative global solutions through highly qualified, globally experienced, knowledgeable local experts. ACROSS Global identifies, analyses and mitigates risks across the entire clinical research spectrum, with an agility and focus to the envy of competitors. We provide value added solutions individually tailored for small and mid-size companies.