Bringing a lifesaving injectable drug to market is challenging. As such, choosing the right manufacturing partner is a lifesaving decision, but one in which many pharmaceutical companies make costly mistakes. Indeed, when sourcing an injection manufacturer in India, there are a few key pitfalls that many companies skip over. This can compromise product quality, lead to regulatory delays, and erode brand trust.
A faulty manufacturing decision directly impinges on the stability of your supply chain and the commercial success of your drug. We explore below the top five most common mistakes. You must be aware of how to avoid these easily made but grave mistakes to ensure you have a reliable, high-quality production partner.
Injection Manufacturer Selection: 5 Mistakes Pharma Companies must avoid
Choosing the ideal injectable manufacturing companies in India, when it comes to practice, companies often forget the basics. The section that follows summarizes five of the most common mistakes in simple points.
Mistake 1: Underestimating Regulatory History
Sometimes, the pharma companies rush ahead, sacrificing much of compliance. They sometimes forget that a company’s history with the FDA or EU-GMP is an excellent proxy for future reliability. Hence, they stand to risk big regulatory hurdles later on.
Mistake 2: Making Price the Sole Deciding Factor
The temptation, no doubt, is to go with the lowest bidder. But affordable manufacturing normally equates to compromised quality control, and this can prove disastrous in the injectable space. Value, not cost, should be the focus.
Mistake 3: Disregarding Specialization and Technology
Most firms do not evaluate the specific expertise of a injectable manufacturer. For instance, a partner specialized in SVP may not turn out to be perfect for PFS. You really have to match the format of the drug with their core competency.
Mistake 4: Supply Chain and Logistics Audit Not Considered
Sometimes, the complete focus of attention is drawn only towards the factory floor. A weak raw material sourcing or cold chain logistics system may spoil a perfect batch, and therefore, you will have to vet the entire supply chain.
Mistake 5: Failure to establish clear lines of Communication
A manufacturing partnership requires a high degree of communication. As such, communication gaps, particularly across borders with the injection manufacturers in India, may lead to costly misunderstandings and delays in production.
Overlooked Due Diligence: Verifying an Injection Manufacturer in India
A solid due diligence process is your best protection. You should never compromise on quality, even more so when you choose a third-party injection manufacturer in India.
- Make it a point to check if the cGMP certifications from the US FDA, EMA, and other global regulators are currently valid.
- Examine the company’s past regulatory observations or warning letters closely and require a comprehensive corrective and preventive action plan.
- Check if there are separate, specialized areas in the plant for the production of products like Beta-Lactam or oncology injectables.
- Look closely at their internal QMS audit reports and SOPs to judge how strong they are.
- Perform a thorough on-site audit, which is not limited to the facility itself but also covers the quality culture among the staff.
Why Quality and Compliance Must Trump Low Prices?
Injectable products demand the highest standards, and hence, economizing on this attribute is indeed a false economy. Quality has a direct bearing on patient safety and access to markets.
- Sterilization assurance and particulate contamination prevention represent expensive processes.
- Poor quality leads to batch rejections, thereby increasing your overall cost.
- Non-compliance with regulations leads to market holds that really delay product launch.
- A strong Quality Management System protects your brand’s good name at all costs.
- An investment in credible injectable manufacturing companies in India secures patient lives.
Ignoring Scalability and Technology Transfer Capabilities
Pharmaceutical growth demands a flexible partner. Thus, most companies regret selecting an injection manufacturer who cannot scale up production quickly. Being a pharma owner, you definitely need to review their capacity at present and their projected expansion plans. Equally crucial is a smooth technology transfer process; this minimizes time-to-market, along with preventing costly process variations.
In addition, you need to guarantee that the injection manufacturers in India will have the skill to manage complicated formulations.
You also need to check their expertise in drug stability and validation, which are the most critical areas. You need to ensure that the chosen injectable manufacturing companies in India have the technological depth your product requires.
Final Thoughts
Choosing an injection manufacturer in India is a decision that dictates your brand’s future. Avoid focusing narrowly on cost. Enlarge the scope of thinking and include the quality, compliance, and scalability for the future.
The necessity of doing extensive due diligence cannot be overstated. Ultimately, you will be able to establish a strong market presence if you associate with a manufacturer who has nothing less than world-class standards and is known for its reliability. Companies like Smayan Injectables epitomize the quality benchmarks available in the industry.
Frequently Asked Questions (FAQs)
Why is regulatory history so important when selecting an injectable manufacturer?
A manufacturer’s regulatory history is a direct predictor of its ongoing commitment to sterility and global compliance standards.
How does scalability affect my long-term pharmaceutical business plan?
Scalability ensures that your partner can handle sudden market demand spikes without blowing out product quality or supply chain stability.
Should I choose the manufacturer whose pricing was the lowest?
Certainly not! Opt for the systems of quality, compliance history, and technical skills of the manufacturer, and not just on price alone.
What is the most substantial criterion in choosing a company for injectable manufacturing in India?
Sterility Assurance Level (SAL) and a robust Quality Management System (QMS) are undoubtedly the single most critical selection factors.
What technological capabilities should I check during the audit process?
Validate the capabilities in dealing with aseptic processing, have specialized filling lines for vials, ampoules, or PFS, and conduct advanced analytical testing.