Manufacturing

API Development and Manufacturing

Axis Hormones is one of the top API manufacturing companies in the world and also one of the very few pharmaceutical companies that are vertically integrated with a presence in the API and Formulations segments. This makes Axis Hormones a truly formidable, fully integrated global pharmaceutical company. By maintaining cost leadership and competitiveness in various therapeutic domains, Axis’s API business has ensured the profitability and growth of the company’s formulation business in addition to being a top API supplier globally. This was achieved by focusing on improving operational efficiencies with a careful and meticulous product selection strategy based on real time market requirements. By maintaining cost leadership, the flexibility to switch manufacturing operations and, the competitiveness in various therapeutic domains, Axis’s API business has been in the top league, globally. We have been the leaders in production and development of High Quality USP grade API (Active Pharmaceutical Ingredient), Axis Hormones can provide the API, eliminating third party from the process and hence ensuring quality,the key advantages of using Axis Hormones.

Our Main Focus in the manufacturing segment is

• Ensuring continuity of supply
• Ensuring consistent quality of product
• Competitive costs
• Resources to respond in a timely fashion to meet demand

Quality

The API research division is housed in a sprawling 15-acre campus with a built up area of over five hundred thousand square feet which houses both chemical and analytical research lab. With experience of commercializing many APIs, the research team is completely attuned to our growth aspirations. Committed to quality, safety and the environment, both of our manufacturing facilities have been inspected and approved by the US FDA, UK MHRA, TGA Australia, ANVISA and other reputed regulatory agencies. Our state-of-the-art manufacturing plants ensure that we deliver quality and scale. We have successfully integrated our capabilities and capacities to deliver a wide product portfolio that caters to the needs of diverse markets. Axis operates dedicated facilities for categories from intermediates to oral and sterile injectable hormones. There are multiple site filings to mitigate the supply risk and to ensure business continuity. Axis API plants are equipped with particle size modifications systems to supply compacted and micronized materials. Manufacturing is backed by warehousing systems that offer ambient control room temperature (CRT) and cold rooms. API plants are equipped by site dedicated quality control laboratories. We practice DIMAP, FEMA methodologies as part of our QMS.

Manufacturing Competency

Drug manufacturing for overseas markets is a highly competitive field and only the very best can survive. It takes a strong infrastructure with a great deal of manufacturing expertise to bring out the finest quality finished formulations. At Axis, we have a long track record of manufacturing pharmaceutical dosage forms for worldwide pharmaceutical markets. We are proud to be able to provide high quality products that can improve the health and quality of life of many people across the globe at reasonable prices. The major drug manufacturing for overseas markets undertaken by us is for American, Asian and East European countries. We have a very good manufacturing infrastructure consisting of modern GMP Certified facilities. We use state-of-the-art equipment and have a team of qualified professionals who ensure that every product that rolls out of our factory will meet the WHO- GMP Guidelines and other world class standards. This allows us to bring out the finest quality finished formulations to cater to your every need.

Utilizing state-of-the-art equipment, we manufacture the following dosage forms:

Sterile Products
Our Manufacturing facilities are fully equipped to manufacture Sterile products including Tablets and injectable Formulations.

Tablets
We manufacture uncoated Tablets, Sugar-Coated Tablets, Enteric-Coated Tablets, etc.

Dry powder for suspensions
We manufacture Dry powder for Suspension and supply them in finest quality vials.

Encapsulated formulations
We manufacture Manual/ semi-automated Capsule filled Powders.

Direct compression granules
We manufacture and supply direct compression granules containing the powder mixture of API and suitable excipients which ready to be compressed into tablets by means of direct compression method.

Others
Our other Specialties include manufacturing of injectables and orals.