Selecting the right third-party pharmaceutical manufacturing company in India is a critical decision for any pharma business. The choice of a reliable and competent manufacturing partner who can deliver high-quality products in a given time period with proper regulatory compliance can greatly impact the success of your business. In India, which happens to be a prominent player in the global pharmaceutical industry, numerous factors should be considered when choosing a pharmaceutical manufacturing company whether you are an importer operating in a different country or a trading company that wants goods under a third-party manufacturing arrangement. In this blog, we will discuss the key factors to consider while selecting the right manufacturing partner for your business:
One of the most crucial factors to consider is the manufacturing company's adherence to regulatory guidelines and quality standards. How can you do that? By asking for various regulatory certifications that are mandatory to obtain in the manufacturing country and in the importing country. Regulatory certifications ensure that the company complies with international standards such as Good Manufacturing Practices (GMP) and has necessary certifications like W.H.O. GMP, Schedule M, cGMP, ISO 9001:2015 to name a few. A company that has a valid GLP (Good Laboratory Practices) Certificate indicates that they have a strong quality control system in place to maintain product quality throughout the manufacturing process.
2. Manufacturing Capabilities and Infrastructure
To evaluate the manufacturing company's capabilities and infrastructure, consider the following factors:
· Daily Production Capacity: This will serve as an indicator to self-evaluate a tentative production timeline.
· Technology and Equipment: This is key, especially in Quality Control Department. Check if the manufacturing company has an in-house or outsourced Quality Testing Lab, or a dedicated Microbiology Lab, especially in the case of Injectables.
· Storage Facilities: Having adequate and temperature-controlled storage facilities is a must as it ensures that the quality of the product is not compromised when the product is in the holding areas waiting in line for the next process.
· Specific Product Requirements: Always get a sample made and submitted to ensure that the product meets your specific requirements. Another way is to order – even if it is paid – a sample of a similar specification product previously made by the manufacturing company and get it tested in an outside testing lab.
· Assess their track record in handling similar products and their ability to scale up production if needed. A well-equipped and adequately staffed facility ensures smooth manufacturing operations.
3. Research and Development (R&D) Capabilities
A manufacturing partner with strong R&D capabilities can bring added value to your business. Assess if the company has a dedicated R&D team and a history of developing innovative products. Their ability to provide formulation development, process optimization, and troubleshooting support can significantly contribute to your product's success.
4. Regulatory Expertise
India's pharmaceutical industry is subject to various regulatory frameworks. Look for a manufacturing company that has expertise in navigating the regulatory landscape. They should have experience in obtaining regulatory approvals, handling documentation, and complying with local and international regulations. You can request a Market Standing Certificate (MSC), a Material Safety Data Sheet (MSD), Certificate of Pharmaceutical Product (COPP) to assess and ensure this. This expertise ensures a smooth regulatory process for your products.
5. Cost-Effectiveness and Pricing
Cost-effectiveness is an essential consideration when selecting a manufacturing partner. Compare the pricing structure of different companies and evaluate if it aligns with your budget and business goals. However, it's crucial to strike a balance between cost and quality to avoid compromising on product standards.
6. Supply Chain and Logistics
Evaluate the manufacturing company's supply chain capabilities, including sourcing of raw materials, inventory management, and distribution channels. A reliable supply chain ensures the timely availability of raw materials and seamless product delivery. Consider their experience in exporting pharmaceutical products, especially if you have plans to target international markets.
7. Track Record and Reputation
Research the manufacturing company's track record and reputation in the industry. Look for testimonials, client reviews, and references from their existing customers. Again, you can request a Performance Certificate which is issued by State Governments upon successfully complying with their norms. This can be a good indicator of their experience and how long they have been in the industry. A well-established and reputable company is more likely to provide these documents.
8. Flexibility and Customization
Assess the manufacturing company's flexibility and willingness to customize its services according to your specific requirements. A partner that understands your unique needs and can tailor their manufacturing processes accordingly can be a valuable asset to your business. Conclusion: While there are more ways to verify the selection of your preferred Pharma Manufacturing Partner, the above article provides various ways to do the initial screening and sift through most of the hurdles that can come during the shortlisting process. The process of Selecting the third-party pharmaceutical Partner may seem extensive and lengthy but it is worth every effort as once the Manufacturer is on-board, it is usually a long and satisfying relationship. Jackson Laboratories Pvt Ltd is a certified Third-Party manufacturing pharma in India; we are offering our services in every part of the nation. Our company has a wide range of DCGI-approved pharmaceutical products. Jackson Laboratories Pvt Ltd is a renowned Third Party manufacturing pharma company in India. We manufacture More than 500 pharmaceutical Formulations in various dosage forms. Overall, Jackson Laboratories Pvt Ltd has a proven track record of delivering high-quality Pharmaceutical products at competitive prices while providing excellent customer support. These factors make it an ideal choice for anyone looking for a reliable and trustworthy Pharmaceutical manufacturer in India.
If you want to know more, you can contact or WhatsApp Jackson Laboratories Pvt Ltd anytime at +91- 9967588042 also you can write a mail to them at business@jacksonlaboratories.com.