Abstract
The pharmaceutical industry is emerging as a significant industrial sector with tremendous potential for providing innovative drugs to treat life-threatening diseases as well as for providing economical generic alternatives of supreme quality. Hence this sector is not only responsible to provide the much desired boost to the health of the society, especially of the developing countries, but also it is a competitive yet profitable sector from a business perspective. Currently, the primary focus of the pharmaceutical industry is to raise the bar for the quality, safety and efficacy of the drug products that are made available in the global market place. Product quality, price of raw materials [API (active pharmaceutical ingredient) and excipients] and market return competition are vital factors that determine the longevity or existence and profitability of a company in the crowded pharmaceutical market. . Hence these critical factors receive special consideration from drug product manufacturers. Active Pharmaceutical Ingredient (API) is the primary constituent of a pharmaceutical drug product that governs the final cost of the drug product as well as the commercial profit earned by the company. Most of the major generic drug manufacturing companies have their own API manufacturing facility and hence may not prefer to screen independent API suppliers as part of their generic drug development plan to procure additional API. Contradictorily, the generic drug manufacturers who do not synthesize the API themselves are dependent on external and independent API manufacturers for procurement of the API. Such generic drug manufacturing companies have to select suitable API suppliers by adapting a risk aversive approach. This article presents an informed and comprehensive discussion on the primary and alternate API supplier selection processes for generic drug products manufacturing firms. This API supplier selection process can be categorized into several stages which include preliminary assessment, documents review, samples analysis, onsite or offsite audit, results evaluation and final approval or rejection. This API selection process includes the anticipated product specific risk assessment with relation to API characteristics, specifications, analytical results, document review observations and inspection results. A generic drug product manufacturing company can choose an alternative API supplier or change the existing API supplier either during the development phase or after development of the drug product. Generic drug product manufacturing companies should rework on development activities if any API supplier change happens during the development phase. API supplier change or addition of an alternative API supplier has to be followed as per SUPAC guidance for US market and VARIATION filing procedures for European market.
Highlights
Drug products are formulated with Active Pharmaceutical Ingredient (API) and excipients
All the approved generic drug products are similar to the innovative drug product; cost of the generic drug product plays a critical role in helping the generic drug product manufacturer acquire a significant market share in the competitive and crowded generic pharmaceutical market
In the highly competitive generic business it is important for the drug product manufacturers to maintain an entrusted long term strategic relationship with the API suppliers to get an early access to high quality active pharmaceutical ingredients as well as to overcome the pricing burdens
Summary
Drug products are formulated with API and excipients. Drug product has to enter the market in any country by adapting either of the two processes viz. new drug product approval process or generic drug product approval process. API selection process should involve a quality and risk based approach by considering the API synthetic route, starting material characteristics i.e. Physical (polymorphic nature, hygroscopicity, particle size, bulk density etc.) and chemical properties (impurities profile, thermal behavior and residual solvents etc.). Document review: Generic drug product manufacturer should review the open part of the API DMF to understand the synthetic route, product specifications, analytical procedure, impurity profile, stability results, and amendments in the API Chemistry Manufacturing and Control part. Regulatory agencies demand to have complete report on the synthetic route of the APIs obtained from the previous and new API suppliers, impurity profile, starting material, residual solvents, polymorphism, physical properties (bulk density, particle size, Hygroscopicity etc.), product specifications and analytical test procedures, in vitro dissolution reports and new batches with new API material.
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