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Corealis Pharma Inc.
Formulation Development and Clinical Supply Manufacturing
Corealis Pharma Inc.
Formulation Development and Clinical Supply Manufacturing
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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.
Cambridge Major Laboratories, Inc. and AAIPharma Services Corp. (AAI|CML) have merged to form a world-class supplier of comprehensive pharmaceutical development and manufacturing services. With over 800 employees operating out of seven sites in the US and Europe, our combined capabilities include API development and manufacturing, solid state chemistry, formulation and analytical development, material testing, finished dosage form manufacturing (solid dose and parenteral), packaging, and stability services.
AAI|CML offers comprehensive services to expedite drug products through the full range of development – from early phase studies to full-scale (commercial) production of APIs and finished dosage forms. In addition to our development capabilities, our network of regional analytical testing laboratories located in St. Louis, MO; Edison, NJ; Durham, NC; and Wilmington, NC provides industry-leading turn-around-times.
CML has five centers of excellence: process chemistry, solid state chemistry, API manufacturing, analytical services, and quality assurance.
To learn more, visit www.aaipharma.com and www.c-mlabs.com.
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:
• CMC Project Management
• GMP Auditing
• Sourcing & Procurement
• Medicinal Chemistry
• Analytical Method Development
• Catalysis Screening
• 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
• Heck Reactions
• HPAPI / High Potency
• High Pressure
• High Temperature
• High Throughput / High Resolution X-ray Diffraction
• Polymorph Screening
• Powder Filling
• X-ray Crystallography
• 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
Integrated Drug Discovery and Development Services
Our integrated offering allows clients to access multiple outsourcing choices across the research and development value chain. We offer the following services
Method Development & Validation
Extractables & Leachables
Syringability, Injectability, & Inhalation Study
Raw Material Qualification
ICH Stability & Release Testing
Impurity Analysis & Contaminant Identification
Pre-Clinical, Clinical, & Post-Approval
Pre-Formulation & Formulation
Solid Stage Characterization
IND & NDA Submission Support
USP Monograph Testing
Overcoming Solubility Issues
Clinical Trial Material Manufacturing
Excipient Base Identification
Chemistry R&D and Custom Synthesis
The HDH Pharma scientific team has earned its reputation through its problem solving skills and out of the box thinking when coping with challenging chemistry.
Synthetic route development
Feasibility analysis of synthetic pathways
Methodology studies for process development
Exploratory studies for original compound synthesis
Custom Synthesis Services:
Pharmaceutical Reference Standards
Building blocks and screening compounds Including:
4, 5, 6, and 7– membered heterocycles, fused heterocycles
Lipids, Carbohydrates, and Nucleosides
Pyridines, Pyrimidines, Purines, Substituted Benzenes, Pyrazoles, Osoxazoles, Oxadiazoles, Indoles and Benzimidazoles
Aza-benzimidazoles, and Azitidine, Pyrrolidine, Piperidine
Indoco Remedies Ltd., headquartered in Mumbai, is a fully integrated, research-oriented Pharma Company with presence in 55 countries. Indoco, a USD 166 million company, employs over 6000 people including over 300 skilled scientists.
The Company has 9 manufacturing facilities, 6 for FDFs and 3 for APIs, supported by a state-of-the-art R&D Centre and a CRO facility. The facilities have been approved by various regulatory authorities such as USFDA, UK-MHRA, DRU Botswana, PMDA-Japan, TGA-Australia, FMHACA-Ethiopia, DPML- Ivory Coast, SAHPRA- South Africa, NDA-Uganda, etc.
Indoco has 9 domestic marketing divisions with a strong brand portfolio in various therapeutic segments including Gastro-intestinal, Respiratory, Anti-Infective, Stomatologicals, Ophthalmic, Nutritionals, Cardiovascular, Anti-Diabetics, Pain Management etc. Top Indoco brands include Cyclopam, Febrex Plus, Sensodent-K, Karvol Plus, ATM, Oxipod, Cital, Sensoform, Sensodent-KF, Cloben-G, Glychek, Kidodent, Carmicide, Rexidin, MCBM, Methycal, etc. On the international front, Indoco has tie-ups with large generic companies across the globe.
Indoco has carved a place for itself in the international arena and is exporting a number of generic products in the Regulated and Emerging Markets. Indoco’s branded formulations are promoted in Emerging Markets of South East Asia, Africa, Latin America and CIS countries. The Company participates in various tenders floated by authorities from different countries. Indoco has tie-ups with large generic companies across the globe and works in close coordination with its customers for leveraging core competencies.
Indoco Analytical Solutions division has been carved to serve customers for their analytical research needs. AnaCipher CRO, Hyderabad, is a USFDA inspected facility providing clinical trial solutions, BA/BE/Phase I/Phase studies.