Third Party Pharma Manufacturing: Outsourcing Success
The pharmaceutical industry is a complex field that is constantly evolving. In this industry, the efficiency of production and quality of pharmaceuticals are most important. However, the high growth and low number of manufacturing companies have affected the industry significantly. That was until third party pharma manufacturing revolutionized this industry. In today’s blog, we will share all the information about third-party pharma manufacturing in the pharmaceutical industry, so stay tuned until the end.
What Is Third Party Pharma Manufacturing
Third party manufacturing in the pharmaceutical industry refers to outsourcing the production of medicines to specialized manufacturers. This is also called contract manufacturing. The businesses providing these services are known as third-party pharma manufacturing companies.
Benefits Of Third-Party Pharma Manufacturing
If you are planning to utilize the benefits of third party pharma manufacturing, you must learn about its benefits. Some may already know a few advantages of third-party manufacturing pharma companies, but let’s check out the points below for a better understanding.
Cost Efficiency
Top-class third party pharma manufacturing companies often have an established infrastructure, which saves manufacturing costs by reducing the expenditure on labor, materials, equipment, etc.
Focus on Core Competencies
Due to third-party manufacturing pharma companies, the client can focus on their research development, marketing, and sales to grow the business.
Quality Assurance
A renowned third party medicine manufacturer always ensures high standards while manufacturing products. This results in high-quality products and reduced regulatory issues.
Production Scalability
Third party pharma manufacturing allows businesses to monitor market demand fluctuations. Depending on demand, they can order manufacturers to increase or decrease production.
Saving Time
Not having sufficient time is the major reason for outsourcing the production of pharmaceuticals. The client companies won’t have to spend time manufacturing and planning products, so they can work on brand management.
Access to Expertise
third party pharma manufacturing companies have deep knowledge about products, which results in better product quality and production efficiency.
Risk Mitigation
Hiring third party pharma manufacturing companies simply means sharing production responsibility. Such companies also have great knowledge, which helps minimize risks related to product manufacturing like chemical spills.
Global Reach
Reputable third party pharma manufacturing companies have a global presence, which helps your business reach international markets and grow even further.
Infrastructure Savings
Leveraging 3rd party pharma manufacturing companies means you won’t need to invest and build your own manufacturing facilities, which can save a significant amount of money.
Product Customisation
A big reason why companies often rely on third party manufacturing pharmaceuticals is the freedom of customization. 3rd party pharma manufacturing companies often provide product customization solutions.
Third-Party Pharma Manufacturing Process
You have learned the benefits of third party pharma manufacturing from the above section. Let’s now uncover its process.
Client Engagement
The process begins with a Client Company reaching out to a third-party medicine manufacturer.
Product Formulation
After the client reaches a third-party manufacturer, they discuss the product. It includes sharing product requirements, formulation details, quality standards, etc.
Regulatory Compliance
The next step in the process is for the manufacturer. The manufacturing company shares information about all its facilities and processes and ensures that they comply with regulatory requirements. The company can also show the licenses and approvals obtained.
Raw Material Obtainment
Now, the third party pharma manufacturing company obtains the raw materials required to manufacture pharma products. This also includes getting APIs (Active Pharmaceutical Ingredients) and testing quality or materials.
Production
This step differs depending on which type of pharma product needs to be manufactured. It can involve blending, granulation, encapsulation, etc. Quality control measures are implemented in the whole process of medicine production.
Quality Assurance
After the product is manufactured, the quality control teams conduct tests to ensure the product meets all quality and safety standards.
Packaging
The packing step comes in third-party pharma manufacturing after the product is qualified for usage. Depending on the specifications of the client, the manufacturing company labels and packs the product.
Documentation
The company documents its manufacturing and quality control processes after the product is packed and ready to be delivered. This helps keep a record of production activities.
Delivery
The finished pharmaceutical product is delivered to a designated location at a designated time, which could be the client company’s distribution center or another place.
Regulatory Filings
Sometimes, the manufacturer helps the client company prepare and submit regulatory filings for medicines.
Key Compliance Aspects Of Third-Party Pharma Manufacturing
Compliance is critical for third party pharma manufacturing and includes:
GMP Standards
GMP stands for Good Manufacturing Practice; it is a set of assurance standards that prove products are manufactured using the best practices.
Regulatory Approvals
Regulatory approvals ensure that a pharmaceutical product is safe and effective. Getting regulatory approvals requires submitting samples of medicine to CDSCO (Central Drugs Standard Control Organisation).
Quality Control
Quality control involves implementing rigorous tests on the medicine to check if it meets all the safety standards.
Documentation
It’s the documentation of the manufacturing process. This step ensures transparency and traceability of the product.
Audits
Conducting regular audits is necessary as it ensures ongoing compliance.
Challenges Of Third-Party Pharma Manufacturing
While third-party pharma manufacturing is pretty beneficial for companies, there are some challenges that you need to be prepared to face.
Reputation
At the current time, several third-party pharma manufacturing companies are coming into the market, so it becomes difficult to choose the right one. So, clients should opt for those third-party manufacturers which have a long history and reputation in the market.
Quality Standards
Ensuring quality standards is one of the biggest challenges in third-party pharma manufacturing. This is because companies are responsible for the safety and efficiency of their products.
Technology
Not all third-party medicine manufacturers utilize advanced technology and facilities. So, client companies need to keep that in mind and search for a manufacturer that uses state-of-the-art facilities.
Communication
Clear communication is crucial; otherwise, issues might not be resolved, which can create problems for both the manufacturer and the client company.
Cost
When partnering with a third-party manufacturer, you always need to verify that you get value for money without compromising on quality.
Dependency
Relying only on third-party pharma manufacturing services can increase the risk of production delays and supply chain disruptions. So it’s good to maintain backup suppliers and diversify the manufacturing base to avoid these issues.
Third Party Pharma Manufacturing: Innovation Meets Quality
At the current time, almost all pharma companies rely on 3rd party manufacturing pharmaceuticals to scale their businesses. Well, that’s quite normal as businesses get several benefits like cost savings, time-saving, access to expertise, etc. However, one must be aware of the challenges of third-party pharma manufacturing, such as reputation, quality standards, and the risk of being overly dependent. Consider all the factors to partner with a perfect third-party medicine manufacturer and scale your business.
Partner with MyKom Laboratories and Elevate Your Pharma Production With Innovative Solutions
Do you wish to avoid the burden of manufacturing and scale up production with minimal effects? Trust MyKom Laboratories for this. We are the leading third-party pharmaceutical manufacturer in India with a wide range of pharmaceutical products for you. Whether you need a tablet, capsule, syrup, injection, or ayurvedic medicine manufacturing and packaging services, we are the one-stop solution for all your needs. We offer customized solutions, guaranteed on-time delivery, and meet global standards for 100% safety and effectiveness of medicines. When you want to expand your product line, we are with you at every step of the process, helping to grow your business. Contact us today!
Frequently Asked Questions
Who is called the queen of pharma in India?
Namita Thapar is often regarded as the queen of pharma in India due to her important role and leadership at Emcure Pharmaceuticals, one of the country’s biggest pharma companies.
Who is the richest pharmaceutical company?
Eli Lilly is the richest pharma company, with an astounding market cap of $814.85 billion.
Who is the king of pharma in the world?
Dilip Shanghvi is considered the pharma king. He is the founder and managing director of Sun Pharmaceuticals Industries Ltd.
Who are the big 3 in the pharmaceutical industry?
AmerisourceBergen, Cardinal Health, and McKesson are the big 3 of the pharma wholesale industry. They handle more than 92% of wholesale drug distribution.
Which company is an example of a GMP-certified third-party medicine manufacturer?
Lifevision Healthcare is the WHO (World Health Organisation)-GMP-certified third-party pharma manufacturer.
What is the difference between PCD and third-party pharma manufacturing?
PCD Pharma has limited control over designing and launching products. The parent company researches, develops, and tests a new product. On the other hand, third-party manufacturing has more freedom. Here, companies can make decisions about designing and launching products.