About to Montek Biophama
MONTEK Biopharma, India's on of the fastest
upcoming pharmaceutical company, is an integrated, research based,
national pharmaceutical company, planning to launch its product in
international market shortly, producing a wide range of quality,
affordable generic medicines, trusted by healthcare professionals
and patients across geographies.
Montek Biopharma came in to existence with a vision to provide world class Pharmaceutical, Cosmaceutical and Nutraceutical formulations, and this vision and hard work, sincerity and dedication of two brother doctors have set the stage for Montek Biopharma to enter in to international arena.
Montek is marketing its own brand on the name of MBP Pharmaceuticals Pvt. Ltd, having its co-operate office at MOHALI (Punjab).
We, at Montek Biophama are committed to:
MANUFACTURING ACTIVITIES AS LICENSED BY NATIONAL AUTHORITY
The company has received license from the state FDA for the manufacturing of:-
Solid Dosage Forms :-
1). Tablets : Coated and Uncoated
2). Capsules : Hard Gelatin Capsules.
Liquid Dosage Forms :-
Liquids : Liquid Syrups and Suspensions, Dry Powder.
Ointments : Aluminium Tubes / Lami Tubes / seamless Tube.
As a member of today’s rapidly changing global
community, we are striving to adapt to the evolving needs of society
and contribute to the overall health and wellness of our world. We
are continually reviewing and improving our efforts to lessen our
impact on the environment, nurture a workplace of diversity and
inclusion, conduct responsible business practices, and uphold the
highest ethical standards in everything from research and
development to sales and marketing. And, we are building
partnerships in communities throughout the world to strengthen
health systems, increase access to our medicines and find
sustainable solutions to the health challenges of today, and
DISTRIBUTION, COMPLAINTS AND PRODUCTS RECALLS 8.1 ABOUT STORAGE AND DISTRIBUTION PRACTICES
Products are stored in the warehouse only after being packed at production area and declared as “ready for dispatch” by QA. The warehouse is a secured area with restricted entry. The temperature requirements are maintained and recorded. The materials are stored on pallets such that there is clear segregation between two lots. The status of the material is identified by labeling. There is separate space for rejected material storage or Recalled product storage.
RECORDS OF DISTRIBUTION
The records of distribution are kept and are available to establish traceability in terms of date of sale, customer details and quantity dispatched. These records are maintained for 1 year past the expiry date of the product.
Quality Assurance, who maintains a Customer Complaints Register, handles the complaints. On receipt of a complaint, complaint investigation is initiated by Quality Assurance. Depending on the nature of the complaint the order related departments are involved in complaint investigation. A complete investigation report is prepared which marjorly includes the control sample test results, batch record review results to understand the cause of the complaint and action taken to avoid recurrence, immediate action/ reply to be given to the complaint. The records of complaint shall be kept for at least 10 years to check recurrence and for academic interest.
Head of Quality Assurance would make the decision if a recall is necessary and define the class of recall. Quality Assurance informs Marketing/ Distribution Dept. to identify the distribution of product of the batch, which is to be recalled. Procedure for handling of recalls have been laid down which includes. - Retrieval of distribution data. Notifications to customers by phone, fax, or e-mail. - Segregation of recall material upon receipt and to keep under lock and key. - Immediate information to relevant authority