Avra Laboratories Pvt Ltd

CordenPharma is your full-service partner in the Contract Development & Manufacturing (CDMO) of APIs, Drug Products and associated Packaging Services. Through a network of cGMP facilities across Europe and the US organized under four technology platforms – Peptides, Lipids & Carbohydrates – Injectables - Highly Potent & Oncology - Small Molecules - CordenPharma experts translate complex ideas, processes and projects at any stage of development into high-value products.

<< Peptides, Lipids & Carbohydrates >>

• Synthetic Peptide API Production
- Solid-phase, Liquid-phase, Hybrid Synthesis
- cGMP & non-cGMP
• Synthetic Lipids
• Carbohydrates

<< Sterile Injectables >>

• New Development & Commercial Suites for Aseptic Filling with > 60.000 units
per day (Pre-filled Syringes, Liquid or Lyophilized Vials)
• Packaging, Labeling & Logistics
• Sterile Emulsion Technology
• Large Pre-Filled Syringes
• Clinical Trial Services

<< Highly Potent & Oncology >>

• API Development & Commercial Manufacturing
(SafeBridge Category 4, OEL ≤1 ng/m3)
- New Development & Scale-up Capacity for Phase I/II Supply
• Drug Product Development & Manufacturing
- New Development Suite (CTD2) for Mid-scale Oral Dosage (up to 20 kg)
- Sterile Liquid & Lyophilization
- Primary & Secondary Packaging

<< Small Molecules >>

• Development & Commercial Manufacturing
- Intermediates
- APIs & Excipients
- Clinical Supply Phases I-III
• Proprietary & Generic Advanced Intermediates & APIs

Visit > www.cordenpharma.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:

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

ChemCon GmbH - Your Good Manufacturing Partner!
ChemCon is a contract development and manufacturing organization (CDMO) located in Freiburg, Germany. We manufacture drug substances (injectable, ophthalmic, oral, topic grade) and ultra-pure chemicals to your specifications. With multidisciplinary expertise we can meet your individual demands for small-molecule organic APIs, inorganic compounds, polymers, and highly potent or controlled substances. ChemCon’s facilities are optimized for the production of small to medium quantities (g to multi 100 kg per year). This is particularly interesting if you are sourcing APIs for clinical trials or commercial applications (i.e., orphan diseases, oncology, or emergency care) with a low annual demand. We also manufacture excipients, provocation substances, dietary trace elements, diagnostics, delivery agents, or reference standards. Your project will be under one roof from synthesis & process development/establishment all the way to commercial cGMP manufacturing, including full documentation, quality control and regulatory support. We also offer external analytical services, independent from production services. ChemCon looks back on an outstanding inspection history by both the FDA and European health authorities. Find our latest company brochure here: https://bit.ly/35ZQm8t

Impressum:
ChemCon GmbH, Engesserstr. 4b, 79108 Freiburg i.Br.
Phone.: +49 (0)761-5597-0; Fax: +49 (0)761-5597-449
E-Mail: Info@chemcon.com
CEO/President: Dr. Raphael Vogler
Commercial register: HRB 5973
Court of registration: Freiburg
VAT Reg. No: DE812753447

Founded in 2004, Pharmaron is a cutting-edge, fully integrated pharmaceutical R&D service platform supporting the life science industry. The company has invested in its people and facilities and established its comprehensive service offerings throughout the pharmaceutical R&D lifecycle. With operations in China, the US and the UK staffed by more than 11,000 employees, Pharmaron has an excellent track record in delivering end-to-end R&D solutions to its partners globally and enabling them to accelerate their novel drug discovery and development process.

Pharmaron is a contract research organization (CRO).

Services:
* Synthetic, medicinal and analytical chemistry services
* Biology services
* DMPK services
* Pharmacology services
* Drug safety assessment services
* Radiochemistry and isotopically labelled metabolism services
* Chemical & pharmaceutical development services
* Clinical development services

www.pharmaron.com

CRO - Contract Research Organization
Library Synthesis
CADD
Bioorganic Chemistry
Discovery Process Chemistry
Radiolabelled Chemical Synthesis
ChemInformatics
in vitro Biology
in vitro Screening
Structural Biology
in vivo Pharmacology
Animal Disease Models
ex vivo Pharmacology
Biomarkers
in vitro ADME
in vivo PK
PKPD
QA
Regulatory Affairs
Discovery Biologics
Process Chemistry
API Manufacturing
Material Science
Formulation Development
Drug Product Manufacturing
Toxicology
Safety Pharmacology
Genetic Toxicology
DART
Pathology
Immunotoxicity
Bioanalytical
14C / Carbon-14 Radiosynthesis
3H / Tritium Radiosynthesis
QWBA
mARG
Clinical AME
Mass Balance
Metabolite Profiling
Microdosing Phase 0
Absolute Bioavailability
DDI
First-in-Human (FIH)
Thorough QT(TQT)
Ethnobridging

TCG Lifesciences Pvt. Limited (formerly "Chembiotek Research International"​) is a leading global Contract Researchand Manufacturing Services (CRAMS) company in the area of drug discovery and development. We started our operations in 2001 in Kolkata, India and currently have our presence in the United States, Europe, and Japan.
We have a strong talent pool of 800+ qualified and trained scientists (including 150+ PhDs), drawn from the best domestic and international institutes and industry. Our services span chemistry, in vitro and in vivo pharmacology, analytical development and validation, and specialty chemicals. We offer specific/functional solutions to integrated projects across multiple therapeutic areas with specific focus on Inflammation & Pain, Infectious Diseases, Central Nervous System and Oncology. Our research infrastructure includes world-class chemistry and biology laboratories, animal facility, electrophysiology laboratory, BSL 2 laboratory, and cGMP facilities at our R&D centers.
Our Offerings:
DISCOVERY SERVICES
Functional Chemistry
• Scaffolds & Building Blocks
• Library Synthesis
• Parallel Synthesis
• Medicinal Chemistry Singletons
• Solid Phase and Solution Phase Peptide Synthesis
Functional Biology
• In vitro Pharmacology
• ADME
• Pharmacokinetics and Pharmacodynamics (PK/PD)
• In vitro Toxicology
• In vivo Pharmacology
Fully Integrated Services
• Medicinal Chemistry Design
• Lead Generation
• Lead Optimization
• Preclinical Candidate Selection

DEVELOPMENT SERVICES
• Rapid Scale-Up and cGMP Kilo Labs
• Route Evaluation
• Hazard Assessment & Reaction Calorimetry
• Process R&D
• Clinical Trial Materials Preparation
Analytical Services
• cGMP Analytical Lab
• Methods Development & Validation
• Forced Degradation Studies
• Impurity Profile Determination
• Impurity Isolation and Characterization
• Preparative Chromatography (chiral, SFC, and HPLC)
• Reference Standards Management
• ICH Stability Studies
MANUFACTURING SERVICES: