Fedley Healthcare is a prominent pharmaceutical company based in Bangalore, India. With over four decades of experience, Fedley Healthcarehas established itself as a leader in the pharmaceutical manufacturing sector, specializing in third-party manufacturing services. The company operates state-of-the-art facilities that adhere to international standards, ensuring high-quality production and compliance with global regulatory requirements.
Experience and Expertise Fedley Healthcare Has a rich history of over years in the pharmaceutical industry, offering unparalleled expertise in drug development and 3rd party pharma manufacturing. The company’s extensive experience ensures reliability and consistency in production, making it a trusted partner for many global pharmaceutical brands.
State-of-the-Art Facilities The manufacturing facilities of Fedley Healthcare Are equipped with cutting-edge technology and modern equipment, ensuring the highest standards of quality and efficiency. These facilities are compliant with international regulatory standards such as WHO-GMP, US FDA, UK MHRA, and EU GMP.
Comprehensive Product Range Fedley Healthcare Offers a wide range of pharmaceutical products, including tablets, capsules, injectables, liquids, and topicals. Their diverse product portfolio allows them to cater to various therapeutic segments, including antibiotics, antipyretics, antivirals, anti-inflammatory drugs, and more.
Quality Assurance Fedley Healthcare Places a strong emphasis on quality assurance, implementing rigorous quality control measures at every stage of the 3rd party pharma manufacturing process. The company’s commitment to quality ensures that all products meet the highest standards of safety, efficacy, and reliability.
Regulatory Compliance Fedley Healthcare’s facilities and processes are compliant with stringent regulatory requirements, ensuring that all products are manufactured in accordance with global quality standards. The company’s compliance with international regulations makes it an ideal partner for pharmaceutical companies looking to expand their global reach.
Research and Development Fedley Healthcare Invests heavily in research and development, focusing on innovation and the development of new formulations. Their dedicated R&D team works on creating innovative solutions that address unmet medical needs and enhance patient outcomes.
Supply Chain Management Fedley Healthcare Offers robust supply chain management services, ensuring timely and efficient delivery of products to clients. Their integrated supply chain capabilities enhance operational efficiency and reduce lead times, providing a competitive advantage.
Client-Centric Approach Fedley Healthcare Adopts a client-centric approach, working closely with partners to understand their specific needs and deliver customized solutions. Their flexible business model and commitment to customer satisfaction make them a preferred partner for many 3rd party pharmaceutical companies.
Contract Manufacturing: Fedley Healthcare Provides comprehensive contract manufacturing services, offering end-to-end solutions from product development to commercial production. Their contract manufacturing services are tailored to meet the specific requirements of each client, ensuring flexibility and efficiency.
Formulation Development: The company’s formulation development services include pre-formulation studies, formulation optimization, and scale-up. Fedley Healthcare’s expertise in formulation development ensures that products are developed to meet the highest standards of quality and efficacy.
Regulatory Support: Fedley Healthcare Offers extensive regulatory support, assisting clients with product registration and regulatory compliance in various markets. Their regulatory expertise ensures that products meet all necessary legal and quality requirements, facilitating market entry and expansion.
Packaging Solutions: The company provides a wide range of packaging solutions, including blister packs, bottle packs, and sachets. Fedley Healthcare’s packaging services are designed to ensure product integrity and enhance shelf-life, meeting the diverse needs of their clients.
To engage in third-party manufacturing in Bangalore, pharmaceutical companies need to ensure they have all the necessary documents to comply with regulatory requirements and establish a smooth operational process. Here are the key documents required:
1. Company Documents
Certificate of Incorporation: This legal document establishes the formation of the company and provides details like the company name, registration number, and date of incorporation.
Memorandum of Association (MOA) and Articles of Association (AOA): These documents outline the company's objectives, rules, and regulations.
Partnership Deed: If the business is a partnership, this deed is essential for legal verification.
2. Manufacturing Licenses and Certificates
Drug Manufacturing License: Issued by the State Drug Control Department, this license is mandatory for manufacturing pharmaceutical products.
Good Manufacturing Practice (GMP) Certificate: This certificate ensures that products are consistently produced and controlled according to quality standards.
WHO-GMP Certificate: Ensures compliance with international quality standards, required for exporting medicines.
3. Tax Registration
GST Registration Certificate: This is necessary for tax purposes and compliance with the Goods and Services Tax regulations.
Tax Identification Number (TIN): Used for tracking transactions and tax obligations.
4. Product-Specific Documents
Product List: A detailed list of the products to be manufactured, including their compositions and strengths.
Approved Formulations: Documents that provide the approved formulations for each product.
Drug Approval Certificate: Issued by the State Drug Control Department, this certificate approves the manufacture and sale of specific drugs.
5. Quality Assurance Documents
Standard Operating Procedures (SOPs): Detailed SOPs for each process to ensure consistency and quality.
Quality Control Reports: Reports and records from the quality control department to ensure products meet required standards.
Analytical Method Validation Reports: These reports validate the methods used for testing the products.
6. Legal Agreements
Manufacturing Agreement: A legal contract between the marketing company and the manufacturer, outlining terms, conditions, and responsibilities
Confidentiality Agreement: Ensures that proprietary information and trade secrets are protected.
7. Labeling and Packaging Documents Fedley Healthcare
Artwork and Design: Approved designs for labels and packaging, compliant with regulatory standards.
Packaging Materials Procurement Records: Documents detailing the procurement of packaging materials to ensure they meet quality standards.
8. Miscellaneous Documents
Bank Statements and Financial Documents: Recent bank statements and financial documents to verify the financial stability of the company.
Power of Attorney: If applicable, this document authorizes a representative to act on behalf of the company.
Ensuring that all these documents are in place will streamline the process of third-party manufacturing in Bangalore and help in maintaining compliance with regulatory standards.
Fedley Healthcare stands out as a leading third-party manufacturing pharma company in Bangalore, offering a comprehensive range of services that cater to the diverse needs of the pharmaceutical industry. With their state-of-the-art facilities, commitment to quality, and client-centric approach, Fedley Healthcare is the ideal partner for pharmaceutical companies seeking reliable and efficient manufacturing solutions. By choosing Fedley Healthcare, companies can leverage their expertise and capabilities to achieve their business objectives and deliver high-quality pharmaceutical products to the market.