Bharat Rasayan Limited

Be Clinic Ready!

Corealis Pharma provides services on a contract basis in the areas of Formulation & Process Development as well as in small scale Clinical Trial Material (Phase I and II) Manufacturing and the packaging of solid dosage forms (tablets & capsules) to pharmaceutical and biotech companies.

Our services include: API characterization; salt selection; pre-formulation; formulation & process development; analytical method development; stability storage & testing; technical transfer and scale-up; cGMP manufacturing & packaging of Phase I and II CTM; dossier support for American, European, and Canadian submissions.

Our experts have access to modern well equipped R&D and cGMP manufacturing & packaging facilities that allow them to successfully complete the most challenging and complex mandates. The primary objective of Corealis and its staff is to make every one of their customers succeed.

Corealis Pharma Inc. offers personalized and efficient services in the areas of Formulation Development and Clinical Supply Manufacturing of solid oral dosage forms.

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

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

Analytical Services
Method Development & Validation
Extractables & Leachables
Syringability, Injectability, & Inhalation Study
Manufacturer Validation
Raw Material Qualification
ICH Stability & Release Testing
Impurity Analysis & Contaminant Identification
Pre-Clinical, Clinical, & Post-Approval


Pre-Formulation & Formulation

Formulation Optimization
Solid Stage Characterization
IND & NDA Submission Support
Counterfeit Analysis
Degradation Analysis
API Analysis
USP Monograph Testing
Dissolution Studies
Overcoming Solubility Issues
Toxicology Analysis
Clinical Trial Material Manufacturing
Excipient Base Identification
Bioequivalence Analysis
Disintegration Studies

Custom Synthesis
Process R&D

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.
Reaction Optimization
Synthetic route development
Feasibility analysis of synthetic pathways
Methodology studies for process development
Exploratory studies for original compound synthesis

Custom Synthesis Services:
Impurities
Building Blocks
Reference Compounds
Reaction Intermediates
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

Teknova expedites clinical breakthroughs by allowing scientists to focus on discovery, product development, and production. An established leader in custom manufacturing for the life science, biopharma, and healthcare industries, Teknova provides critical reagents for bioprocessing, bioproduction, and molecular diagnostics. Product offerings include cell culture media and supplements, protein and nucleic acid purification buffers, and molecular biology reagents.

Priding itself on its agility and customer centricity, Teknova meets the most complex formulation and packaging requirements and delivers with unrivalled speed. The company supports research, clinical, and applied markets with catalog and custom products, delivering cost savings for research, development, and production of diagnostics, vaccines, and therapeutics. All products are manufactured in facilities that are ISO 13485:2016 certified, US FDA 21 CPR Part 820 compliant, and FDA registered.

As a partner to the biopharma sector, Teknova provides end-to-end solutions in the development of reagents and processes for a multitude of established and emerging applications, including vaccine production and gene therapy. The company’s R&D team offers expertise from prototype product design to guidance on GMP manufacturing of media, buffers, and reagents for the entire gene therapy workflow.

Teknova was founded in 1996 by Ted Davis, a Genentech scientist, who identified the need for custom media and buffers manufactured to the same quality standards as commercially available, inventoried solutions. The company headquarters and research services facility are located near the San Francisco Bay Area in Hollister, CA, USA, with additional facilities in Mansfield, MA, USA.

Zhejiang Zhongshan Chemical Industry Group Co. Ltd., is a world leading Agrochemical manufacturer company. It is established by Mr. Li Bugao in July 1998 and three plants were setup in Zhejiang Province, Anhui Province and Jiangsu Province in the following days.

Anhui Zhongshan Chemical Co. Ltd., a member of ZSchem Group, product quality at all times remains our primary concern. We are the only manufacturer of Triazine herbicides products with WDG formulation that is both ISO 9001 and ISO 14001 certified. Besides, our new core products Mesotrione, Bentazone and Metamitron has occupied a leading position in product quality and output capacity.

Located in Lianyungang, Jiangsu Zhongshan Chemical Co., Ltd. is the newest plant we developed. The total investment amount of Jiangsu plant will reach 300 million RMB. After full construction finished, our crop protection products range will cover not only herbicide but also fungicide and insecticide. All these effort makes us can better serve customers from almost every region of the world and support the agriculture with complete crop protection solution.

Our headquarter, R&D center and formulation plant locate in Changxing city, Zhejiang province. ZSchem R & D team is managed by 60 members of chemical experts with titles of professor, senior chemical engineer and PhD. We have good relationship and cooperation with Universities and Research Institutes around China. The world famous Adjuvant companies like Huntsman and Rhodia offer us proprietary support team service and customized adjuvant solution to guarantee the quality of our products.

Covering an area of 12 hectares, our formulation plant have advanced formulating equipment of SC, WP and WDG, full automatic small scale packing plant and warehouse & logistic system. We have already covered 90% kinds of existing formulation and mixture in all kinds of packaging with great sustainable feedback from end users.