Basic Knowledge of Pharmaceutical Companies: How To Learn

Table of contents

• Introduction and outcome
• Pharmaceutical Industries
• Manufacturer of Drug Substances
• Manufacturer of Dosages Forms
• Difference between Active Pharmaceutical Ingredients (API) and Dosage forms
• Various departments of Pharmaceutical industries
• A bird’s eye view of Generic and Contract Manufacturing
• Carrier in the Pharmaceutical industries
• Top 10 companies in India
• Conclusion

Introduction and Outcome; Basic Knowledge of Pharmaceutical Companies

“Pharmaceutical Companies“ play a vital role in our lives since they develop and manufacture medicines. It encompasses the knowledge of research and development, manufacturing process, Quality control, Quality assurance, safety, and marketing strategies involved in the production of Pharmaceuticals or Pharmaceutical products. It is essential for individuals working in these industries to have a deep understanding of these concepts to excel in their respective roles to produce high-quality medicine. In this article, I will discuss skill-based knowledge about pharmaceutical companies and it will clear all your doubts related to pharmaceutical Companies.

Pharmaceutical Companies

Pharmaceutical companies are involved in the development, manufacture, and marketing of drugs for medicinal use. There are various types of the Pharmaceutical industries:

• Manufacturer of Drug Substances and
• Manufactures of Formulated products or Dosage forms

Manufacturer of Drug Substances

This type of pharmaceutical industry is involved in the discovery, development, manufacturing, and marketing of Active pharmaceutical ingredients (APIs), intermediates, and raw materials.

For example, Paracetamol API is manufactured using different pharmaceutical raw materials like Phenol, Nitric acid, Nickel catalyst, Acetic acid and Ethanol.

Active Pharmaceutical ingredient (API) = Key starting material/Starting material + other raw materials

Manufacturer of Dosage Form

This particular branch of the pharmaceutical industry is responsible for developing, manufacturing, and marketing various dosage forms such as tablets, capsules, syrups, and injections. These dosage forms contain both active pharmaceutical ingredients (API) and inactive pharmaceutical ingredients.

For instance, a Paracetamol 650mg tablet may weigh 1 gram or more than that. This means that the tablet contains 650 mg of Paracetamol (API) and 350mg of excipients such as Calcium stearate, Cellulose, Sodium Benzoate, Starch, and Hydroxypropylmethylcellulose

Dosage Form = API + Excipients

Difference between Active Pharmaceutical Ingredients (API) and Dosage forms

Following are the major differences between API and Dosage Forms:

Various departments of Pharmaceutical Companies

The following are some major departments of the pharmaceutical industry:

• Chemical Research department (CRD): The Chemical Research Department (CRD) is tasked with the responsibility of developing drug substances through synthesis.
• Analytical Research department (ARD): ARD is engaged in analytical research activities such as method development, method validation, technology transfer, and impurity control strategies.
• Formulations and development department (F&D): F&D is responsible for Dosage Forms development.
• Production department: Production department is responsible for the manufacturing of the Drug substances or Dosage Form as procedure.
• Quality control department (QC): The QC department is responsible for testing and releasing Drug substances and Dosage Form according to the monograph.
• Marketing department: Marketing department acts as a bridge between supply and demand of medicine.

Apart from the above mentioned departments, other departments such as Quality Assurance department, Human Resources (HR), Safety, Supply Chain, and Regulatory play a major role in the manufacturing of drug substances or dosage forms.

You may like: GLP (Good Laboratory Practice) | How To Implement

A bird’s eye view of Generic and Contract Manufacturing

Generic Medicine company

Generic medicine companies produce non-patented versions of existing drugs without the need for research and development. Generic Medicines are cheaper than the branded medicines.

Third-party manufacturing pharmaceutical companies or Contract Manufacturing Organizations (CMOs)

Third-party manufacturing pharmaceutical companies, also known as contract manufacturing organizations (CMOs), are companies that produce pharmaceutical products on behalf of other companies. These companies don’t own the products or brands but manufacture them for pharmaceutical brands or businesses that outsource their production.

The following are their working procedure:

1. Outsourcing Manufacturing: Pharmaceutical companies that don’t have the capacity, expertise, or resources to manufacture their products in-house often contract third-party manufacturers to produce drugs. This allows the brand owners to focus on other areas like R&D, marketing, and distribution.
2. Services Offered: These third-party manufacturers provide a range of services such as:
   • Formulation development (e.g., tablets, injections, syrups)
   • Manufacturing (bulk drug production, packaging)
   • Quality control and testing
   • Regulatory compliance (ensuring products meet local or international regulatory standards)
   • Logistics and supply chain management
3. Types of Third-Party Manufacturers:
   • Full-service manufacturers: Handle everything from raw material procurement to final product packaging.
   • Specialized manufacturers: Focus on specific drug forms or stages of production, like solid-dose forms (tablets), injectables, or biologics.
4. Advantages:
   • Cost-effectiveness: Outsourcing can save companies on infrastructure, labor, and manufacturing costs.
   • Expertise: Access to specialized manufacturing processes and state-of-the-art facilities.
   • Flexibility: The ability to scale production up or down based on market demand.
   • Faster time to market: By relying on experienced third-party manufacturers, companies can get products to market faster.

Carrier in the Pharmaceutical industries

Here are some career opportunities in the pharmaceutical industry:

Top 10 companies in India

The following are some major Pharmaceutical companies:

Why is it one of the most profitable businesses in the world?

High Research and Development (R&D) Costs and Barriers to Entry

1. The development of new drugs involves extensive research, clinical trials, and regulatory approval processes, which can cost billions of dollars. However, once a drug is approved, it often becomes highly profitable, particularly if it addresses a widespread medical need or offers a unique therapeutic benefit.
2. The industry also benefits from significant intellectual property protections, such as patents. A patent on a new drug typically grants the manufacturer exclusive rights to sell that drug for 10-20 years, allowing them to recoup their R&D investments and generate high profits during that time.

High Margins on Drugs

• Pharmaceuticals often have very high profit margins, particularly for branded, patented drugs. Once a drug is developed and approved, production costs are relatively low compared to the price at which it is sold. Even though generic competition may emerge after patents expire, the initial period of exclusivity can result in massive profits.
• High prices for certain drugs, especially specialty medications or biologics (e.g., cancer treatments or gene therapies), contribute to the industry’s profitability. These treatments can cost tens of thousands, or even hundreds of thousands, of dollars per year, leading to enormous revenue potential.

Global Demand for Healthcare

• As populations age and chronic conditions like diabetes, heart disease, and cancer become more prevalent, the demand for pharmaceutical products continues to grow worldwide. Developing countries are also increasingly able to afford healthcare, creating new markets for both generic and branded medications.
• Advances in biotechnology, personalized medicine, and precision therapies have opened up new areas for profit, especially with treatments for previously untreatable or rare diseases.

Government and Health Insurance Systems

• In many countries, healthcare is heavily subsidized or funded through government programs or private insurance. Pharmaceutical companies often negotiate large contracts with governments, health insurance providers, and healthcare systems, ensuring substantial sales volumes.
• In the U.S., for example, the government and private insurers cover the cost of medications for millions of people through programs like Medicare and Medicaid, creating a stable demand for prescription drugs.

Market Exclusivity and Price Control

• In some cases, drug prices are not directly regulated by governments (as they are in other industries), allowing pharmaceutical companies to set high prices based on demand and competition. Price controls exist in some countries, but many pharmaceutical companies can still charge a premium in markets where they have exclusive rights.
• The process of obtaining regulatory approval for new drugs (e.g., through the U.S. FDA or European Medicines Agency) also creates a barrier to entry, meaning new competitors have difficulty entering the market quickly and undercutting prices.

Monopolistic Practices and Patent Cliffs

• The pharmaceutical industry has been known for engaging in practices such as “evergreening” (extending patent protection by making slight modifications to existing drugs), limiting competition, or delaying generic versions of drugs through litigation.
• Once patents expire, generic versions can be produced at a much lower cost, but the initial period of exclusivity still generates significant profits.

Strategic Acquisitions and Mergers

Large pharmaceutical companies frequently acquire smaller biotech firms with promising drug candidates, sometimes paying billions of dollars for them. These mergers and acquisitions help large companies maintain their product pipelines and diversify their offerings, ensuring sustained growth and profitability.

What is the pharma franchisee?

A pharma franchisee is a business model in the pharmaceutical industry where an individual or company (called franchisee) obtains the right to sell and distribute the products of an established pharmaceutical company (called franchisor). This agreement allows the franchisee to operate under the brand name and use the franchisor’s business model, marketing strategies, and products.

The following are their working procedure:

1. Franchisor’s Role: The pharmaceutical company that owns the brand or product line offers its products to a network of franchisees. It provides them with the right to distribute these products in a specific region, training, marketing support, and sometimes exclusive access to certain products.
2. Franchisee’s Role: The franchisee invests in the business, usually by paying a franchise fee, and assumes responsibility for selling the pharmaceutical products within the agreed territory. They may also be responsible for local marketing, distribution, and sometimes stocking and inventory management.
3. Benefits for Franchisees:
   • Brand Recognition: The franchisee benefits from the reputation and trust established by the franchisor’s brand.
   • Support and Training: The franchisor typically provides ongoing support and training in product knowledge, regulatory requirements, and business management.
   • Reduced Risk: As the products are already developed, marketed, and recognized, the franchisee faces less risk than starting a business from scratch.
4. Benefits for Franchisors:
   • Expansion: By partnering with franchisees, the franchisor can expand its reach more quickly without the need for substantial capital investment or direct management of new locations.
   • Local Expertise: Franchisees often have a better understanding of local markets and customer needs, which can lead to better sales and growth.

Pharma franchisees are particularly popular in countries with a strong pharmaceutical market, such as India, where the demand for medicine and healthcare products is high. This model is attractive to individuals or small businesses looking to enter the pharmaceutical sector with lower risk, leveraging the established reputation of a larger company.

Conclusion

The pharmaceutical industry is considered to be one of the best industries in terms of career opportunities. I hope this article has enhanced your knowledge about this industry and will help you make informed decisions about career opportunities within it. Please feel free to share your suggestions or questions related to this article in the comment section, and I will respond to them on a priority basis.

FAQs

What is the basic knowledge about the pharmaceutical industry?

Knowledge related to development, manufacturing and marketing of drugs is called basic pharmaceutical industry knowledge.

What is the basic knowledge of pharmaceutical analysis?

The knowledge related to analytical techniques and methods required for quality monitoring at various stages during drug development and manufacturing is called basic knowledge of pharmaceutical analysis.

How can I improve my pharma knowledge?

You can join your pharma knowledge by reading articles or joining online courses at pharmaknowledgeforum.com . You can also improve your knowledge by reading books and attending seminars.

Who is the father of pharmaceutics in India?

Mahadeva Lal Schroff is the father of pharmaceutics in India

What is a drug in pharmaceutics?

A pharmaceutical intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease is called drug

What is an assay in pharma?

The relative quantitative value of a pharmaceutical against the reference standard is called the assay.

What is pharmacology basic knowledge?

The study of medicine that deals with how the drug works, how the body reacts to it, and the changes that occur over time is called pharmacology. It involves many processes such as understanding how organisms handle drugs, identification and validation of new targets for drug action, and design and development of new drugs.

What is the basic knowledge of B Pharm?

In Pharma focus is given to basic knowledge of pharmaceutical chemistry and pharmacology

What is the basic knowledge of pharmaceutical chemistry?

Pharmaceutical (medicinal) chemistry deals with the drug design, research and synthesis of active pharmaceutical ingredients (APIs)

What is the basic pharmaceutical process?

The pharmaceutical process involves many processes like drug development, drug manufacturing, mixing, granulation, milling, coating, tablet pressing, filling, packaging etc.

What are the best jobs in pharmaceutical Industry?

The best job depends on your interest. There are a lot of opportunities in the pharmaceutical industry and you can join departments like research or production, quality control, marketing, QA, supply chain, warehouse etc. depending on your interest.

What is regulatory affairs in pharmaceutical industries?

The main duty of the regulatory department is to ensure that organizations comply with all applicable laws, guidelines and standards, often set by government bodies or international regulatory agencies. Such as filing DMF, answering queries on deficiency letters and coordinating with customers and various authorities.

Abbreviations:

• API: Active pharmaceutical ingredient
• CRD: Chemical research and development
• ARD: Analytical research and development
• QC: Quality control