The manufacturer of the specific Palbocent 125 mg product is: Incepta Pharmaceuticals Ltd.
This information should be established from product packaging, an official regulatory database, manufacturer documentation or another reliable product-specific source.
Pfizer and IBRANCE
Pfizer is the documented developer and company associated with IBRANCE, the reference product containing palbociclib. Pfizer announced the initial FDA approval of IBRANCE in February 2015.
European reference-product information
The EMA identifies Pfizer Europe MA EEIG as the marketing authorization holder for Ibrance in the European Union.
Palbocent is a separate product identity
The existence of Pfizer’s IBRANCE product does not establish that Pfizer manufactures Palbocent.
The following distinctions should be preserved:
| Role | Palbocent information |
|---|---|
| Specific manufacturer | Incepta Pharmaceuticals Ltd. |
| Product owner | Incepta Pharmaceuticals Ltd. |
| Marketing authorization holder | Incepta Pharmaceuticals Ltd. |
| Distributor | Incepta Pharmaceuticals Ltd. |
| Supplier | Incepta Pharmaceuticals Ltd. |
| Relationship to Pfizer | Incepta Pharmaceuticals Ltd. |
| Relationship to IBRANCE | Incepta Pharmaceuticals Ltd. |
Manufacturing and quality information
Specific manufacturing sites, GMP certifications, batch-release arrangements and quality certifications for Palbocent are:
Incepta Pharmaceuticals Ltd. About the Manufacturer
Incepta Pharmaceuticals Ltd. is a leading pharmaceutical manufacturer in Bangladesh, established in 1999. The company develops and manufactures a wide range of pharmaceutical products for the domestic and international markets. Its major manufacturing facilities are located in Savar and Dhamrai, Bangladesh.
Incepta manufactures different dosage forms, including tablets, capsules, oral liquids, injections, eye drops, creams, ointments, gels, nasal sprays, prefilled syringes, lyophilized injections, and biological products. The company also focuses on technologically advanced dosage forms and pharmaceutical research and development.
Address: Incepta Pharmaceuticals Ltd. 40 Shahid Tajuddin Ahmed Sarani, Tejgaon I/A, Dhaka-1208, Bangladesh
These claims should not be inferred from the reference product’s regulatory documentation.
Why this distinction matters
A pharmaceutical product can involve several organizations. The company that discovered a medicine, the company that owns a reference brand, the company that manufactures a particular product and the company that distributes it may not be the same entity.
For this reason, Palbocent-specific manufacturer information should remain explicitly identified as requiring verification until documentary evidence is available.