How Do You Choose The Right Pharmaceutical Contract Manufacturer For Your Pharma Products In Latin America
Pharmaceutical Contract Manufacturer

How Do You Choose The Right Pharmaceutical Contract Manufacturer For Your Pharma Products In Latin America?

The development of a new medicine is a complex task and requires many iteration and decisions before a commercial launch. Some biotech and pharmaceutical companies in Latin America choose to outsource most or all of their medicine manufacturing efforts throughout the development phase with a contract manufacturing organization.

However, choosing the right contract manufacturer in Latin America is crucial in pharma manufacturing to ensure product success as well as your pharma company’s performance.

Enlisting the right pharmaceutical contract manufacturing organization is a critical decision that puts your brand’s reputation, supply chain, and patient safety in someone’s hands. For the best pharma product manufacturing relationship, here’s how to choose the right contract manufacturer.

Know What You Need From Them

The first step of choosing the right contract manufacturer in Latin America is to know precisely what you need. There are various CMO relationships you can have based on your business needs. For example, a tactical contractor is ideal for a single project or to become a helping hand in in-house productions.

Working with a contract manufacturer in South Africa can allow you to establish an ongoing and long-term relationship without giving too much control over decision-making. Otherwise, a strategic partnership with a CMO is a long-term relationship between you and the CMO to accomplish defined business goals by maximizing the effectiveness of each participant’s resources.

Many pharmaceutical companies in Latin America and South Africa are looking for a reliable CMO to support their projects-right from the development phase to clinical trials and commercial pharmaceutical API manufactures and production and drug manufacturing, product formulation, and packaging. For these pharma companies, a strategic partnership is the best option.

 

Create a List of Top Contract Manufacturing Organization

Create a shortlist of top pharmaceutical Contract manufacturers you’re interested in working with, and analyze every CMO on the same characteristics and needs to single out the right partner eventually. Finding contract manufacture in Latin America is as simple as searching local CMOs or asking industry colleagues for references.

Ensure Quality and Compliance Standards

For safety and your reputation, the pharmaceutical contract manufacturing service you choose should be reliable. Make sure that they have a strong standing with regulatory agencies like the FDA and WHO. Check if they have had in past relationships for gaps in quality and consistent drug manufacturing.

Do not forget to request a report of their recent inspections, audits, and investigations. You won’t want to hire Third-Party contract manufacture in Latin America, Middle East, and South Africa that doesn’t host regular inspections and audits—or one that may be hiding their poor results. This could result in your product shipments’ drug delay or cancelation due to your contract manufacturer’s poor compliance.

Consider Their Experience and Expertise

Considering the capabilities of potential CMOs is an essential step in the process. You’ll need to determine if your pharmaceutical drug manufacturer has the capability and expertise required to manufacture your product. To do so, think about their expertise and experience. You do not want to become the trial run for your CMO, so find out about their previous experience.

Read research and reviews, ask for referrals, or consider hiring a consultant to help evaluate CMO’s profile. You must request that your CMO share key performance indicators they have in place and their success in meeting client expectations.

When evaluating their expertise, you’ll have to make sure it is in the realm of what you’re looking for. This shows they can finish similar needs. However, don’t just assume they have the right capabilities depending upon what they’ve done previously. You’ll still have to be upfront about exactly what you are looking for to make sure they meet your individual expectations and requirements.

Room for Growth

Like choosing a CMO with broad pharma manufacturing services, the pharmaceutical contract manufacturer in Latin America should provide room for growth. An ideal CMO can grow with your pharma product’s success. As such, this contract manufacture should have the proper equipment, staffing, and flexibility to handle your production cycle as it grows.

Confidentiality

The issue of confidentiality can be crucial when it comes to formulation development. A confidentiality agreement is a must-have document, and it should be draft in a way to benefit both parties. Evaluate how the potential CMO ensures confidentiality. The pharmaceutical contract manufacturer should have a system in place that limits the usage of client names or initials, locks data in a secure area, and sends separate client passwords for electronic access to documents.

There are many things to consider when choosing the right CMO in Latin America for your pharmaceutical product. Carefully assessing your needs, capabilities, reputation, the CMO’s abilities, and previous expertise is the ideal way to build a successful partnership.

 

You may also like to read these blogs:-

Best Indian Pharmaceutical Tablets Supplier in Latin America

Pharmaceutical Manufacturing

How to choose the right pharma contract manufacturing company from India?

There is no denying that that pace and amount of contract manufacturing in the pharmaceutical industry has grown significantly over the last couple of years. There are numerous reasons why pharmaceutical companies decide to outsource or contract out their manufacturing activities. JoinHub Pharma deals in Third party pharma and contract manufacturing in India. Each and every manufacturing is done in our company-owned WHO-GMP certified units. A recent Frost and Sullivan report on outsourcing in the pharmaceutical industry referred to the following factors as some of the main reasons why pharmaceutical companies choose to outsource:

• Outsourcing can decrease overall expenses by 30% to 35%
• Faster and less expensive to have discovery work outsourced, decreases drug development cost
• Reduces problems faced during the regulatory processes around the globe
• Improves producing efficiencies
• Reduces excess production limit by divesting facilities
• Minimizes investments in capital-intensive facilities
• Improves net earnings and income
• Diverts resources to concentrate on different competencies like marketing

The report additionally states that outsourcing can permit pharmaceutical companies to establish consistency and proficiency across the sprawling supply chain, international networks of commercial, and manufacturing organizations and, whenever managed and executed strategically, can possibly add to shareholder value and keep the investment community happy. No small accomplishment in this time of economic turmoil.

Contract Manufacturing Market Size
The ever-increasing expenses of R&D combined with poor bottom lines and low productivity has constrained many pharmaceutical companies to outsource both research and development and manufacturing activities to low-cost nations, thereby saving expenses and time in the process. With increased activity in outsourcing, the worldwide market for such services has grown from roughly $57.2 billion in 2007 to an expected $76 billion this year. India, with a large share of US FDA-approved manufacturing facilities, is one of the most-liked locations for outsourcing manufacturing services.
Be that as it may, with outsourcing come concerns. Many pharmaceutical firms often managing long-distance and confused collaborative third-party relationships and afraid of losing control in proprietary knowledge and procedures, and delays because of regulatory hold-ups and imperfect processes.”

Certification
All Pharma Manufacturer must be WHO-GMP certified Manufacturer and few is WHO or equivalent Regulatory approved. One can’t hope to get 500 or 1000 boxes made from WHO-approved plants as there is not much statutory compliance that has to adhere, for small batches consider EU GMP certified Manufacturers.

Product Portfolio
Choosing a company with an extensive product portfolio is significant. Some Pharma Companies don’t offer a wide range of products which implies your rivals may have the edge over you and would have a superior possibility of converting a doctor. JoinHub Pharma provides over 1000 Products in different therapeutic segments which will help you in getting ahead of other PCD Pharma Companies.

Delivery
Maintaining the timeline is very important ordinarily it takes around 30-45 days for delivery of the first batch of products and on repeat order 30 days. Anyway, it might differ by not many days here and there. Kindly note the days referenced is after the design is approved not when the PO is raised.

Rates
It’s very hard to find the Manufacturer with lowest rates however for this it is suggested to contact multiple vendors to pick the best. Rates are directly proportionate to the Raw material which is fluctuating nowadays subsequently its advisable to place the order within 7 days of negotiations otherwise there are chances that when you will place the order the rates are changed because of the changes in the Raw material cost.

Agreement
Most of the Pharma contract manufacturer now requires an agreement with the marketing organization one regarding Trade name of the product, Marketing firms need to give an affidavit to the manufacturer that the Trade name of the brand under production has a place with the company and it reimburses the manufacturer in case of any trade name related issues.

Choosing a CMO
To discover more about the issues that face the industry when considering contract manufacturing, JoinHub Pharma recently finished a survey on “Choosing the Right Contract Manufacturer” We asked you, our readers, what particular qualities and capabilities you search for in a contract manufacturer. The survey results are printed here, yet some fascinating takeaways include:
• 60% of respondents intend to utilize the services of a CMO in the following year and a half.
• Particular product experience and cost were referred to as the two most significant CMO characteristics.
• Nearly 75% of all respondents would not hesitate to pick a CMO not based in their own nation.
• Expertise with a given application or service is the main explanation used to choose a CMO.
• Reputation is everything, and a poor reputation is the kiss of death for a CMO; FDA cautioning letters don’t help either.
• Confidentiality is significant. A history of being discrete with numerous customers is a prime CMO determination factor.
• With international regulatory agencies expanding their scrutiny on CMOs, respondents referred to finish cooperation during a recall as a significant CMO attribute.

These are a few factors that can assist you in choosing the Best Pharmaceutical Manufacturer in India. For more updates on pharma contract manufacturing company in India and how we can help you, please contact our team.

CALL ME BACK