Understanding Active Pharmaceutical Ingredients

Where to buy active pharmaceutical ingredients in India?

Active pharmaceutical ingredient (API), also known as active ingredients or bulk drugs, are purchased from API manufacturers or bulk drug dealers in India. As the Indian chemical industry is slowly adapting to digitization, the purchase of chemicals is also going digital. Online platforms like Carbanio.com has given a new dimension to chemical purchase in India, making it easier and more efficient. The hassle of finding the right supplier with the required purity has been reduced by the introduction of digital processes. The details of chemical purity, supplier location, real-time availability, and the pricing norms are all available just a click away. Buyers have to choose their requirement from the supplier and place the order; the chemical will get delivered in the estimated time.

A wide range of active pharmaceutical ingredients and intermediates are available for purchase at Carbanio.com, at great deals. Carbanio is the most reliable platform for buying chemicals; the company even offered an uninterrupted chemical supply to the pharmaceutical companies during the nationwide lockdown. So, why are you still struggling looking for chemical suppliers? Switch to Carbanio.com and purchase chemicals in style and at the comfort of your home or office.

What are active pharmaceutical ingredients?

An active pharmaceutical ingredient (API) is referred to as the biologically active component of tablets, capsules, or any other drug products. They form the primary ingredients in the formation of a drug product. These APIs are combined with other biologically safe ingredients called the excipients, to form a composition mixture called the “formulation,” which is further used in the manufacturing of the drug.

APIs forms the backbone of the pharmaceutical industry, but oftentimes it is difficult to purchase active pharmaceutical ingredients due to quality and purity issues. Fret no more. Carbanio.com is at your rescue! Carbanio.com has a list of only verified sellers for your peace of mind, with over 7 lakh chemicals listed, you can browse through the list and choose the one that suits your requirement and wait for the chemical to deliver at your doorsteps. So, next time when you want to buy active pharmaceutical ingredients, look no further.

Important guidelines for manufacturing of APIs

Medicines are used to cure human beings; but do you know that they can be equally harmful if compromised on the purity and quality of the APIs and other intermediated used? There are strict guidelines imposed for manufacturing of drugs in bulk. Since the pharmaceutical industry uses biological active ingredients, the manufacturing process, plant configuration, and the technologies used are different from the other chemical manufacturing processes.

Safety measures play a significant role in the API manufacturing, not just to avoid the chemical contamination but also to ensure employee safety as the process contains hazardous chemical reactions that can lead to fatal accidents and property loss. Safety measures also involve the restriction of chemical pollution into the environment. The first step in manufacturing the APIs is to ensure that the plant is in a contamination-free environment. If the plant is in a pollution-prone area, chances of contamination are high and the final product will not have the required purity and can be harmful for human consumption.

Hygiene and sanitation are of utmost importance when it comes to the production of pharmaceutical products. The employees should be trained and encouraged to follow the necessary hygiene and sanitation practices to reduce the risk of contamination. In addition to personnel hygiene, the cleanliness of the entire premises is also important.

Any compromise on the cleanliness, hygiene, maintenance, and unsatisfactory facility standards may lead to regulatory impositions which may further lead to closure of the manufacturing unit.

Regulatory compliance

API is directly linked to human health; hence, quality is mandatory rather than being a choice. The rules and regulations for manufacturing APIs and handling them are clearly defined in every country across the globe. To have a check on the malpractices in the drug products, regular audits are conducted; in case, a company is found to follow malpractices may even lead to the cancellation of the manufacturing license.

The API standards of any company should comply with cGMP (‘current’ Good Manufacturing Practice). This is a system that controls the authorization and licensing of the manufacture of pharmaceutical products and medical devices, in addition to food, beverages, dietary supplements, and cosmetics. cGMP is a statutory and regulatory requirement for manufacturing of active pharmaceuticals ingredients. Hence, the implementation of good manufacturing practices in the pharmaceutical industry is mandatory and a legal requirement.

cGMP compliance involves:

  • Safety, quality, and purity of the drug
  • Well-designed in-process checks
  • Approved equipment which are calibrated regularly
  • Specification for raw materials to meet the standard requirement
  • In-process control procedures as per the protocol
  • Validated analytical methods
  • Annual review of the API quality
  • Stability testing

All of the above mentioned are mandatory regulatory requirements. In an event of failure to meet these requirements may lead to the warning letter from the regulatory agencies. This may further lead to stopping the manufacturing process or even seal the unit in extreme cases of malpractices. Most of the warning letters are issued on the grounds of not following the standard practices for laboratory controls, quality system, inadequate equipment calibration, investigation of failures, inadequate procedures and data integrity, and no proper records and reports.

Regulatory audits have revealed many malpractices in the global pharmaceutical industry, especially data integrity has become a serious issue. Companies should be careful while dealing with the API materials, as warning letters may have a negative impact on the brand value of a company.

Rules and regulations are not always constant; they are subject to alteration over time to suit the current requirement of the industry.

Handling and storage of APIs

APIs should be handled and stored according to the approved protocol. Here are the important steps to follow while dealing with APIs and intermediates:

  • The raw materials are kept in the quarantine area until it is approved.
  • The storage area of APIs and intermediates are cleaned and sanitized thoroughly to eliminate even the tiniest contaminants.
  • The containers used to store APIs are cleaned and sanitized.
  • APIs should be stored under appropriate conditions of temperature and humidity to ensure their stability.
  • Before approving the purchased lot of API, check for the details of batch number, quantity details, and expiry date.
  • Rejected APIs should be isolated from the storage area to avoid any further confusion.
  • The packing and repacking of the APIs and intermediates should be done as per the cGMP norms.
  • All packaging material should be tested for quality and inertness, before finally using them for storage. This step is important to avoid any contamination from the packaging material.

The Global API Market

The global active pharmaceutical ingredient market is estimated to grow at a CAGR of 6.1% by the end of 2024, raising from $182.2 billion in 2019 to reaching $245.2 billion during the forecast period. The increase in the API came as a result of increasing incidence of chronic diseases, growing importance of generic drugs, and the increasing uptake of biopharmaceuticals. While there are various favorable factors contributing, the market may also fluctuate considering the unfavorable drug price control policies of various countries and also the increasing number of the counterfeit drugs in the market.

Asia is the hub for manufacturing of APIs, especially China and India. The trend of outsourcing the API manufacturing from China and India are increasing to reduce the cost on expensive equipment, infrastructure, and the employee cost.

Based on the type of synthesis, APIs market can be categorized as:

  • Monoclonal Antibodies
  • Hormones and Growth Factors
  • Cytokines
  • Fusion Proteins
  • Therapeutic Enzymes
  • Recombinant Vaccines
  • Blood Factors

Top API manufacturers

  • TEVA Pharmaceuticals
  • Dr. Reddy’s
  • Pfizer
  • Novartis
  • Sanofi
  • Boehringer Ingelheim
  • Bristol-Meyers Squibb

Impact of COVID-19 on APIs manufacturing

A huge respect to the COVID-19 frontline workers – doctors, nurses, lab assistants, janitors, and all the healthcare workers who are working beyond time during this critical pandemic times. Even the pharmaceutical industry is under immense pressure and working hard in the battle against the COVID-19 pandemic. In spite of the regional lockdown, maintaining social distancing norms on the manufacturing floor, and disruption in the chemical supply chain, pharmaceutical companies are trying hard to manufacture and supply the required APIs and intermediates to the research intuitions.

Carbanio.com has made immense contribution in supply of chemicals to the research institutions to find the vaccine for COVID-19. In a news earlier this year, CSIR-IICT (Council of Scientific and Industrial Research – The Indian Institute of Chemical Technology), Hyderabad and IISER (Indian Institutes of Science Education and Research) Berhampur made announcements as how Carbanio.com helped them in successfully and effortlessly sourcing chemicals even during the nationwide lockdown. IISER even stated that it believes the adaptation of digitization will make the chemical purchase easy, quick, and convenient.