Manufacturing
Astrozen Pharmaceuticals Pvt Ltd. is one of the rapidly growing pharmaceutical companies as a result of its combine strength in research and manufacturing. Our associate manufacturing facilities follow strict GMP guide lines. & We are committed to provide High quality Generic as well as Ethical Medications, our manufacturing partners have been rewarded with WHO GMP, NAFDAC, Kenya, Ghana, Cameroon, Tanzania, DPML-Ivory Coast and Our most of associated units are approved by EU GMP, USFDA and PIC/S. & ISO 9001 certifications. We take precautions to ensure that all facilities, from design to maintenance follow the highest international standards. Cross contamination at any level is avoided by quarantined production blocks with independent air systems.
• We manufacture in accordance with stringent international quality standards
• Our standards are regularly verified through audits conducted by clients and international authorities.
• Our combination of service options, capabilities, expertise and facilities provides clients a distinct advantage
• Our operational staffs are highly educated and heavily trained in GMP and the most current trends.
Why we have the Manufacturing
Astrozen Pharmaceuticals Pvt. Ltd. is one of the rapidly growing pharmaceutical companies as a result of its combine strength in research, manufacturing & marketing of high quality of pharmaceuticals products. With the sole aim of producing high quality products through deep research and understanding, the company aims to become one of the largest manufacturers in its sector. The research team at Astrozen Pharmaceuticals Pvt. Ltd. is constantly involved in improving quality and reducing cost of its product to meet the market competition.
Contract manufacturing
We Astrozen Pharmaceuticals Pvt. Ltd. specializing in the Research, development and manufacture of Pharmaceutical Formulations Like Anti-biotics, Analgesic, Antacids, Anti-malarial, Anti-tuberculosis, Anti-hypertensive, Anti-Diabetics, Nutraceuticals, Dentals, Skin care Products to seek out an outsourcing relationship worldwide based entirely on the needs of the organization.
Our associate manufacturing facilities are located across five different locations in India which giving us a wide range of production capabilities. Our team of experts take the client’s brief carefully and with precision delivers products to our clients.
Astrozen Pharmaceuticals Pvt. Ltd. provides large scale production capacities, highly qualified manufacturing and quality control staff, state of art -cGMP certified manufacturing facilities combines to give a perfect environment for outsourcing or contract manufacturing pharmaceutical and healthcare products. With multiple cGMP compliant facilities across India Astrozen Pharmaceuticals Pvt. Ltd. is the flexible, efficient, and cost-effective solution for all of your contract manufacturing needs.
Regulatory Affairs
Regulatory Affairs department is key link between company, products and regulatory authorities of different countries.
We Astrozen Pharmaceuticals Pvt. Ltd. have a well experienced, young and dynamic team of Regulatory Affairs consists of elite, highly qualified professionals engaged in providing data required to assure the high Quality, efficacy and safety of our Products. We can provide clinical Trials, Impurity Profiles, DMF, BE/BA Studies for registration of our products as per guidelines of health authorities in both Regulated and Non-Regulates markets. We have tie ups with well-established study centers which are approved from local DCGI and other international regulatory authorities, to carry out Clinical / Pre-clinical studies for various dosage forms.
Our teams of regulatory affairs professionals work closely to develop and implement viable strategies to move projects from conception to approval.
We have requisite infrastructure & expertise to support our associates with excellent technical and Regulatory submission (ACTD, IND, CTA, NDA, CTD, DMF, ANDA)
Astrozen Pharmaceuticals Pvt. Ltd. has Regulatory experts for each country and region which ensures that we have up-to-date local knowledge of the submission process, specific to the country.
Astrozen Pharmaceuticals Pvt. Ltd. understands the significance of high-quality documents to the relevant Regulatory Authorities to ensure that approvals are made in a timely fashion.
The Regulatory Affairs staff assigned to your dedicated Project Team work to ensure the successful and timely submission of your product application.