Rise of 3rd Party Medicine Manufacturing

The Pharma industry is growing at the highest rate in its history because of the immense demand for health products, rising population, growing health consciousness & numerous other factors. Moreover, with the Rise of healthcare, businesses are finding intelligent methods to manufacture pharma medicines with an affordable solution. They need a middleman who can effectively balance productivity, and they don’t need to incur high expenses. It was at that time that 3rd party Medicine Manufacturing was the most effective method to manufacture pharma medicines at affordable prices without losing quality. In India, as in a country where Pharmacy is a broader concept, 3rd party Pharma Manufacturing is not only an option or a convenience, but also has become the growth driver of startups & new companies. In this Article, we are going to elucidate in detail 3rd party Manufacturing Pharmaceuticals, its history, business growth, and market trends.

History of 3rd party Medicine Manufacturing

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  • First, 3rd party manufacturing pharmaceuticals in India was merely a requirement to achieve higher productivity of pharma medicines at minimum costs, but now it has turned into a growth driver for numerous companies. For instance, 183.6 billion was the worth of Contract manufacturing in 2023.
  • Since India is a prominent nation, it caters to 50% of the world’s demand for vaccines & 20% of generic drugs. Throughout India, 70% of companies are outsourcing 3rd party pharma manufacturing services. Consequently, with 3000+ 3rd party medicine manufacturers, India is dominating the overall pharma sector.

Pharma Business Growth with 3rd party Medicine Manufacturing

The pharma business is increasing, with the help of a 3rd party medicine manufacturer in India. This is primarily because they offer quality pharma medicines without damaging the company budget. Furthermore, some major assists that 3rd party manufacturing companies give to the pharma business are as follows:

1. Capital Efficiency:

If any pharma company builds & maintains an in-house production, then it will be costly due to including various things such as: machinery, compliance infrastructure, skilled labour, ongoing maintenance & many more. In contrast, 3rd party medicine manufacturer handles all the things & provides directly finished products to you.

2. Faster Time to Market:

Through the assistance of 3rd party medicine manufacturing, the pharma industry can quickly expand with a quicker time to market. Once a new drug is introduced into the market, the manufacturing company instantly initiates production for the pharma industry because it has an established production line. This is the primary reason why 3rd party manufacturing pharmaceuticals in India assists in expanding the pharma industry.

3. Access to Expertise:

Pharma medicine production is a time-consuming process since it requires quality control, compliance with regulatory norms & many other things which are required for each medicine. As a result, being a 3rd party manufacturer, it has all the compliances & an experienced staff, who continuously do various jobs of quality control, which contributes to the pharma business growth.

4. Flexibility & Scalability:

As you are aware, the pharma industry is dynamic, and the demand can change at any time in the market. Adjusting the demand & volume of pharma medicine is the most difficult part for pharma companies, which is where a 3rd party medicine manufacturer in India comes in handy. They manufacture pharma medicines as per the demand of the pharma business.

5. Focus on Core Competencies:

Manufacturing of medicines consumes a lot of time & because of that, pharma companies can’t provide adequate attention to the right direction, i.e., research & new trends, as well as marketing. However, since the pharma industry has come up with third-party manufacturing, it is developing at a rapid rate by concentrating on more aspects.

Current Pharma Market Trends Driven by 3rd Party Manufacturing Pharmaceuticals in India

Thanks to the growing pharmaceutical industry, 3rd party Medicine Manufacturing is taking its position globally. The following are some emerging pharma market trends:

1. AI-Powered Pharma Medicine Discovery:

Artificial intelligence has a crucial part in the emerging trends of the pharma market. With AI integration, the pharma sector can easily discover a new drug for formulation. Thus, AI simplifies the process of discovery & encourages the development of pharma medicine production.

2. Precision Medicine:

The accuracy of the medicine also enhances the future need for medicine. Here, the creation of medicine is based on the patient’s condition; we can term it as personalised, too. Consequently, with precision medicine, physicians can conveniently treat the appropriate patient with the appropriate medicine.

3. Growth of Biopharmaceuticals:

Today, Biopharmaceutical drugs are primarily ordered in the market for the cure of severe diseases related to living cells. Moreover, Third-party manufacturing is now expanding in Biopharmaceuticals & implementing new technologies in medicine production.

4. Sustainable & Green Manufacturing:

The foremost & most significant trend that is being followed by the pharma industry is sustainable & green packaging. 3rd party pharma manufacturing adopts the methods of production that do not damage the environment & help in the sustainability of the medicine. In addition, different 3rd party manufacturing companies are using the green manufacturing approach for the pharma product production.

5. Digital Health Integration:

Digital Health integration is also a recent trend in the pharma sector, which is preceded by 3rd party pharma manufacturing. Various 3rd party manufacturing companies are bringing digital technology, such as apps, machines & various digital devices with which patients can easily analyse their health.

Products Offered in 3rd party Medicine Manufacturing

3rd party manufacturer attempts to simplify the outsourcing process, easy, flexible and clear for all its pharma customers.
3rd party Medicine Manufacturing is redistributing pharma medicines or having the product manufactured from another manufacturing facility, with your brand name on it. In other words, 3rd party pharma manufacturing, or Contract Manufacturing, means manufacturing of medicines in your company or brand at another manufacturing facility.

  • Tablets – This comprises different tablets and formulation types (e.g., immediate-release, delayed-release, or extended-release tablet products).
  • Capsule – This contains capsule product(s), which are solid dosage forms made of gelatin or a vegetarian shell containing powdered or liquid medication.
  • Dusting Powder – This includes powdered product(s) that are labelled as dusting powder (products intended for dusting onto the skin or other surfaces).
  • Soap – This includes generic soap product(s), which are typically over-the-counter personal care products.
  • Sachet – This includes generic products packaged in sachets (sachets are small, single-use packets).
  • Lotion – This includes generic lotion product(s), which are semi-solid topical products that can be applied to the skin.
  • Hand Sanitiser – This section encompasses generic hand sanitiser products, which are hand hygiene products.
  • Suspension / Syrup / Solution / Drop – This includes suspension, syrup, and/or solution and drop, which are liquid dosage form products (s) that can be used for a variety of routes of administration (e.g., oral, topical, ocular).
  • Ointments – This includes ointment products – semi-solid, oil-based preparations that are applied to the skin for either local or systemic effects.

Products Segments Covered by Leading 3rd Party Manufacturing Companies

1. Tablets Segment:

Tablets are a very common solid oral dosage form for use in patients. They are typically manufactured by taking powdered active pharmaceutical ingredients (APIs) and a variety of excipients (fillers, binders, disintegrants, and lubricants) and compressing these into a single compact.

Notably, a tablet formulation retains some advantages compared to other solid dosage forms (e.g., not being a compounded mixture), such as an accurate and concise dose being available (consistent with a prescribed strength), and it can be easily formulated for different drug release profiles.

2. Capsule Segment:

Capsules are also a commonly used solid oral dosage form that is very similar to tablets, except they are made of a gelatin or vegetarian shell, and the material used to fill the capsule can be either powder or a liquid.

Additionally, capsules are frequently used due to the difficulties related to swallowing tablets and to mask any taste for the patient. Capsules can also be manufactured for particular modified-release profiles (e.g., delayed, extended) to deliver the API consistent with the desired dosing characteristics.

3. Dusting Powder Segment:

The “Dusting Powder section” likely pertains to powdered formulations; however, it is under 21 CFR Part 347 and may include topical formulations such as dusting powders for skin conditions or even wound care.

Dusting powders can serve to absorb moisture, provide a protective barrier, click through the content, and deliver active ingredients directly to the affected area.

4. Generic Index (Soap, Sachet, Lotion, Hand Sanitiser):

These sections are indicative of generic over-the-counter (OTC) personal care products that are typically non-prescription, non-cosmetic items. The “Generic Index” reflects the 3rd Party manufacturer’s generic personal care product lineup. Manufacturers are very competitive in the health care product marketplace for generic products,  typically referred to as generic personal care products; these common personal care items include:

  • Soaps: cleansing and skin care products that are designed to be used for personal hygiene.
  • Sachets: typically designed to be single-use packets or pouches of formulations, but could also be a personal care item, food supplement, or pharmaceutical sample.
  • Lotions: semi-solid emulsions that could be fully topical, designed to protect or hydrate skin, or deliver active ingredients for impact on skin.
  • Hand sanitisers: alcohol-based, made for hand hygiene and control of infection.

 

5. Suspension / Syrup / Solution / Drop:

This section includes various liquid forms of pharmaceutical formulations that vary in characteristics and applications:

  • Suspensions: Mixtures of solid particles (e.g., active pharmaceutical ingredients) in a liquid vehicle; these formulations improve the bioavailability or stability of poorly soluble drugs.
  • Syrups: Liquid forms of preparations that contain high sugar content, commonly used for oral paediatrics involved to improve taste “palatability” and improve acceptance.
  • Solutions: Clear liquid forms of preparations, when the active ingredient is completely dissolved, are advantageous for dispensing active ingredients at certain doses or volumes, and are easy to administer.
  • Drops: Liquid forms of preparations intended for topical or ophthalmic use on skin or membranes.

6. Ointments

Ointments are semi-solid, oil-based preparations intended for topical use on skin or mucous membranes. In particular, ointments can provide a means by which active ingredients are delivered for local or systemic action via topical application; for instance, to treat dermatological conditions. Ultimately, ointments are used more than other topical forms in part because they facilitate hydration and absorption of active ingredients.

What are the Benefits of 3rd Party Medicine Manufacturing?

  • Cost-effectiveness: 3rd Party medicine manufacturing can save a lot of money when it comes to infrastructure, equipment, labour, and regulatory affairs.
  • Emphasis on Core Competencies: The client company may focus on its areas of strength, including research, development, marketing, and sales, while outsourcing the manufacturing to specialists.
  • Infrastructure and Expertise: 3rd party pharma manufacturing tends to own state-of-the-art manufacturing units, advanced technology, and experienced staff with domain expertise in production operations.
  • Quicker Time-to-Market: The use of the capabilities and infrastructure of a third party can make product development and manufacturing faster.
  • Flexibility: Third-party manufacturing provides flexibility in the level of production. It enables companies to vary production levels as per market demand without the necessity of large investments in manufacturing plants.
  • Regulatory Compliance: Well-established third-party manufacturing is familiar with regulatory guidelines and quality control policies. This helps to ensure products with manufactured by industry standards and guidelines.
  • Risk Mitigation: Companies can minimise the risks involved in the production, quality check, and regulatory issues by utilising experienced third-party manufacturing, as these functions are taken care of by the manufacturing partner.
  • Cost Savings: Through the ability to skip investing in manufacturing infrastructure, equipment, and staff.
  • Customisation: Third-party manufacturing tends to provide solutions that are customizable to suit the particular requirements of the client.
  • Global Reach: Working with leading 3rd party medicine manufacturing can open up international markets in which the manufacturing partner has an established network of distributors and regulatory approvals.

Why Choose a 3rd Party Pharma Manufacturer In India?

1. Rapid Product Development and Prototyping:

New product development along with product testing, is crucial in the pharmaceutical industry and collaborating with a third-party manufacturer in India certainly has the potential to accelerate the development of products.

2. Full Service Offering:

Besides manufacturing, third-party manufacturers in India can help with virtually any service that can be beneficial for the company. Such services include product development, graphic design of the product label, regulatory document filing, clinical research and even logistics following manufacturing.

3. Market Diversification and Product Specialisation:

If you are contemplating entering new segments or new areas of treatment, having the right third-party manufacturer as a partner can give you the necessary expertise, technology and market infrastructure to achieve your objectives.

4. Adaptability to Compliance Requirement Adjustments:

Third-party pharma manufacturers in India have an in-depth understanding of international markets’ regulations, which are in constant flux. You can hire such a manufacturer’s services, assured that all your products will be compliant with all regulations, which will, in return, avoid delays or complications that typically come from regulations.

5. Cost-effective Startup Batch Production:

Rather than spending enormous investments on large-scale production premises, various manufacturers allow you to produce small-scale batches at a much cheaper rate.

6. Smart Asset and Supply Chain Planning:

A trusted third-party pharma manufacturer in India can offer your company efficient inventory control services like proactive management of inventory levels, on-time deliveries and quick response communications to swiftly changing demand.

7. Green and Environmentally Friendly Production Policies:

With the world becoming increasingly more conscientious and consumers beginning to prioritise green products, some third-party pharma manufacturers in India are implementing greener production modifications.

Frequently Asked Questions ( FAQ )

Q1. What Is 3rd Party Medicine Manufacturing?

Ans: It is a simple question that every individual wishes to know. Therefore, whenever a company intends to market products branded under its name, it opts for 3rd party medicine manufacturing.

Q2. Is the Third Party and Contract Manufacturing actually the Same or different?

Ans: They are the same, or to put it another way, a single activity with two names.  Third-party services are also trendy with the designation of contract manufacturing. Generally, pharma businesses provide manufacturing contracts for pharma medicine to other businesses.

Q3. Why Do Pharma Businesses Like To Opt Third-Party Manufacturing?

Ans: Plenty of advantages that drive the pharma experts towards opting for pharma manufacturing. Those benefits are:

  • It takes a lot of money.
  • While also saving time.
  • Hassle-free concept.
  • Way to get quality products.
Q4. How should I select the 3rd party medicine manufacturer in India?

Ans: In contract manufacturing, reliability is of prime importance. Therefore, when you entrust the pharmaceutical manufacturing contract, the client has to ensure that this contract is in safe hands. First, verify the market reputation of the manufacturer, and then check how they produce the product, and their personnel should be experienced.

Q5. What is CGMP for pharma manufacturing?

Ans: You should seek a manufacturer who complies with all the regulations prescribed by CGMP. Current Good Manufacturing Practice requirements are enforced by the FDA, which is otherwise known as CGMP.

Q6. How does one obtain third-party pharma manufacturing?
  • Submit your list of items to produce.
  • Upon discussing prices, the manufacturer will provide you with a price quote.
  • Select the artwork and layout of your products.
  • File the required contract agreement documents.
  • The manufacturer will proceed with production.
Q7. What are the minimum requirements for obtaining contract production?

Ans: The minimum requirements for joining a third-party manufacturing company are among the most common third-party manufacturing questions. Therefore, below are the documents that are required to work with a contract manufacturing company;

  • GST
  • Drug Licence
  • Pan Card
Q8. How do you test your Products to ensure quality before shipping them to customers?

Ans: We possess state-of-the-art facilities within our laboratories and closely coordinate with external suppliers for regular testing. In particular, the labs are outfitted with the best technology to guarantee our products are of the highest quality.

Q9. What is the lead time for receiving the products on Third Party Manufacturing?

Ans: The lead time for receiving the products from Third Party Manufacturing is approximately 20-30 days.

Q10. Why do pharmaceutical companies opt for third-party manufacturing?

Ans: A pharmaceutical company could pursue Third-party manufacturing if it does not have an owned manufacturing unit or its manufacturing unit’s capacity is nearing capacity.

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