One thing you already know is, in case you are in the pharmaceuticals, sourcing, or market research business. In the middle of any completed drug lies Active Pharmaceutical Ingredients or APIs. Even the most brilliant of the formulation plans would become useless without a stable supply of API. India has emerged as the pillar of Global Pharma supply chain, particularly of APIs, over the past two decades.
This blog describes the place of Indian API manufacturers in the global image, its importance to the buyers in different countries, and how information technology platforms such as Chemxpert Database can assist you to monitor this rapidly changing world.
Knowing The Global Pharma Supply Chain
The supply chain of Global Pharma is complicated. It is spread through sourcing of raw materials, manufacturing of API, formulation process, packaging, regulatory permits, and distribution. The stages are based on timing, quality and compliance.
APIs sit upstream. Any interruption in this trickles down and affects the finished dosage manufacturers, hospitals and patients. This is the reason API sourcing is not operational but strategic.
Supply chains are under new pressure as the pharma market size of the world keeps increasing. The generics are increasing in demand. Treatment of chronic diseases is on the increase. And governments are driving in the direction of supply security following world shocks in the past.
In this scenario, API manufacturing centres are of greater importance than ever.
The Reason Why India Became A Global API Hub
India was not an API leader within a day. The change was accomplished in a combination of policy, skill, cost structure and regulatory experience.
Here’s what sets India apart:
- Mass pool of chemistry and pharmaceutical science talent.
- Several decades of experience in provision of regulated markets.
- Economical production without having to sacrifice compliance.
- Good history with US FDA, EMA, etc.
In the present time, the API manufacturing firms in India export APIs to North America, Europe, Latin America, Africa, and some parts of Asia. India is a source of quantity and consistency to numerous generic manufacturers in the world.
India also compliments backward integration. There are a number of manufacturers that manufacture major intermediates internally minimizing the risks of dependence.
India’s Role in the World Pharma Market Size
The global pharma market is continuing to grow, owing to the aging population and the increased access to healthcare, as well as increased incidences of diagnosis. The demand of API rises with the increase in the finished drug volumes.
Here, India is a stabilizing factor. The percentage of APIs produced by Indian plants is large in generics that are used in the US and Europe. This provides the pharma corporations worldwide with an affordable cost structure to produce affordable medicine.
As a buyer, India assists in balancing between three priorities:
- Scale
- Compliance
- Cost control
Such a balance is difficult to gain in other places on the same scale.
Indian API Manufacturing Companies: What Makes them Competitive
The Indian API manufacturers have various segments. They are small molecules, fermentation-based API, high-potency API, and niche chemistry.
Key strengths include:
Regulatory Familiarity
Frequent inspections are done on most of the export orientated plants. The documentation systems are well developed. Quality systems are in line with the international expectations.
Flexible Production Models
Manufacturers deal with large-volume APIs as well as with smaller niche molecules. This is flexible in relation to generic launches and managing lifecycles.
Speed to Scale
When the demand is high, Indian firms increase their production at a rapid rate. This becomes essential in times of shortage or market twist and turn.
Contract Pharma Manufacture Integration
There are numerous API suppliers that collaborate with formulation partners. A number of them have API and finished dosage units, which enhance coordination.
APIs and Contract Pharma Manufacturing
Contract pharma production depends on the availability of API. Everything is slowed down by delays or quality at the API stage.
India is conducive to contract manufacturing in three aspects:
- Consistent supply of API to the in-house and external formulators.
- Training during transfer of process and scale-up.
- Contracts on a long-term supply of stable price.
International pharmaceutical firms are turning to Indian counterparts not only to get volume, but also to get continuity. This is important in the introduction of generics to different markets.
You are in charge of sourcing then you are aware of this. The suppliers of API are no longer vendors. They are partners.
Resilience in Supply Chain in the wake of Global Upheavals
The last few years revealed the flaws in concentration supply chains. Diversified sources of API are now demanded by many countries. India is quite compatible with this change.
Indian manufacturers are building capacities, new blocks, and making investments in the backward integration. Domestic API production of essential molecules has government incentives.
For global buyers, this means:
- Less reliance on country sourcing.
- Better continuity planning
- More negotiation leverage
That is why long-term Global Pharma strategies revolve around India.
Decisions Made on Data as API Sourcing
Price is no longer the only factor in the selection of an API partner. You need visibility into:
- Manufacturer profiles
- Plant locations
- Regulatory approvals
- Product portfolios
- Export history
It is here that structured databases come in.
Chemxpert Database is a database that assists teams in following data points on api manufacturing firms in India. You do not have to hunt down pieces of information, but will have a unified picture of manufacturers, products and compliance indicators.
This saves time and lessens the risk to the market research teams, procurement heads, and strategies planners.
The Standing Of India In Relation To Other API Regions
China is one of the large API manufacturers. Europe is more specialty and high-value API-oriented. India is a country in between these models.
India combines:
- Broad product coverage
- Competitive pricing
- Regulatory maturity
This renders Indian suppliers appealing to high-volume generics as well as complex molecules.
This position is all the more valuable in the face of the expanding pharma market size in the world.
Challenges that Indian API Manufacturers Continue to Face.
The picture is not perfect. The Indian API manufacturers are engaged in:
- Fluctuation in the costs of raw materials.
- Costs in environmental compliance.
- Growing attention to supply chains all over the world.
Nevertheless, to counter this many firms react by investing in greener processes, enhancing of traceability and fortification of documentation systems.
These enhancements are confidence-enhancing in the long run as seen by a global buyer.
What This Means for You
In case you are the employee of Global Pharma, India already has an influence on your supply chain. The actual issue is how well you know it.
Better visibility leads to:
- Smarter sourcing decisions
- Less risk of disrupting supply
- Better bargaining strengths
Chemxpert Database and other structured platforms are also useful in keeping up to date because the landscape is evolving.
Final Thoughts
Indian API manufacturers are not suppliers only. They form part of the supply chain of Global Pharma. With the increased demand and the changes in sourcing strategies, the role of India can only get closer and not distant.
In the regulated market, the knowledge of the api manufacturing companies in India is no longer a choice especially among companies that operate in the market across a regulated market. It belongs to conducting business in the world where the pharma market continues to grow and supply security issues.
When you wish to maneuver around this space with clarity data is of equal importance as the relationships.
