Finished Dosage Form
Hubei Bafeng Pharmaceuticals & Chemicals Share Co., Ltd. (hereinafter referred to as "Bafeng pharmaceutical" or "the company") was established in 1997, which is a national key high-tech enterprise and has become one of the largest medical amino acid Industrialization Bases in China. The company's business scope includes Amino Acid APIs, Amino Acid Preparations, and Amino Acid Derivatives.
Why Choose Us
Our Factory
Bafeng Pharma Joined Grand Pharmaceutical (China) Co., Ltd. in 2022, and together with Wuhan Grand Hoyo Co., Ltd., it became the core enterprise of its amino acid sector in the field of biotechnology; Under production department: 1st, 2nd, 3rd, 5th and 6th plants and power engineering equipment branch.
Professional team
Established a postdoctoral research workstation, a postdoctoral industrial base, and the Hubei Amino Acid Technology Center, and established long-term industry-university-research cooperation with scientific research institutes such as the Institute of Microbiology, Chinese Academy of Sciences and Wuhan University.
Quality assurance
Construction of quality system is strengthened by formulating quality target, supply necessary resources, reasonable plan, organization and coordination. The purpose is to make sure the certification can be realized smoothly and improve quality system constantly.
Our service
We adhere to the quality policy of "quality first, customer first". We have a quality management organization, a complete quality monitoring network and an efficient after-sales service system. The quality management system is constantly improving.
A Finished Dosage Form (FDF) refers to the final form of a pharmaceutical product that is ready for administration to a patient without the need for any further modification. This term encompasses a wide variety of drug delivery systems, including tablets, capsules, injections, creams, ointments, and more. The development of FDFs is a critical phase in the pharmaceutical manufacturing process, involving the combination of active pharmaceutical ingredients (APIs) with excipients to create a product that is safe, effective, and convenient for patient use.
Provide Accurate Dosage: Manufacturers deliver medications in exact amounts to meet patient needs.
Enhance Convenience: They design dosage forms to simplify administration and encourage patient adherence.
Guarantee Safety: They protect medication from degradation and contamination.
Specification of Finished Dosage Form
We offer the following Product specifications：
|
Drug name |
Glutamic Acid, Alanine and Glycine Tablets |
|
Specification |
0.41g / tablet |
|
Indications |
Used for frequent urination, dysuria and urinary retention caused by prostatic hyperplasia.(Especially suitable for cardiopulmonary function |
|
Usage and dosage |
Take 2 tablets orally once, 3 times a day, or appropriate increase or decrease according to the condition. |
|
Adverse reactions] |
No relevant adverse reactions have been reported |
|
Taboo |
Prohibited for those who are allergic to this product. |
|
Drug name |
Compound Amino acid oral solution (14AA) |
|
Specification |
50ml per bottle (total amino acid: 5.082g) |
|
Indications |
This product is an amino acid drug, which can improve the ratio of branched chain amino acid / aromatic amino acid caused by various liver diseases, promote the synthesis of albumin in plasma, and be used in the adjuvant treatment of chronic liver disease and cirrhosis caused by viral hepatitis and other causes. |
|
Usage and dosage |
Oral administration, 100ml once, 1-2 times a day, or medical compliance |
|
Adverse reactions |
No relevant adverse reactions have been reported. |
|
Taboo |
Prohibited for those who are allergic to this product. |
The two main parts of any pharmaceutical product are the active pharmaceutical ingredient (API) and the excipient (additional chemicals used to aid in the drug's delivery). Chemically inert fillers like lactose or cellulose derivatives would be some examples of the excipients. APIs form the crux of the finished dosage form - the main ingredient that's meant to meet the objectives of the prescription.
Each drug's (API) strength is measured against industry standards during production. However, there might be significant variations in quality across different manufacturers. The testing procedures used by each manufacturer can cause substantial variations in product efficacy.
The FDA requires manufacturers to demonstrate their medications' efficacy in laboratory settings and clinical trials involving actual patients.
Clearly define all manufacturing processes. Review them systematically in the light of experience. Show that they are capable of consistently manufacturing drugs of the required quality that comply with their specifications.
Validate critical steps of manufacturing processes and key changes to the process.
Provide all key elements for GMP.
Write step-by-step instructions and procedures in clear and direct language, specifically applicable to the facilities used.
Train operators to properly carry out procedures. Ensure they understand the importance of meeting GMP requirements as part of their role in assuring patient safety.
Create records (manually and/or by recording instruments) during manufacture. Show that all the steps required by the defined procedures and instructions were in fact followed, and met relevant parameters and/or quality attributes. Show that the quantity and quality of the drug was as expected.
Document any deviations. Investigate significant deviations to determine the root cause and impact. Ensure proper corrective and preventive action is taken.
Keep records of fabrication, packaging, labelling, testing, distribution, importation and wholesaling in an easy-to-understand and accessible form. This allows the complete history of a lot to be traced.
Distribute products in a way that minimizes any risk to their quality and takes account of Canadian good manufacturing practices which incorporate good distribution practice.
Control storage, handling and transportation of drugs and their ingredients to minimize any risk to their quality.
Have a system in place for recalling drugs from sale.
Examine complaints about drugs. Investigate the causes of quality defects. Take appropriate measures to prevent problems from happening again.
Certificate
Drug Manufacturing License, Writing Confirmation for Active Substance Export to EU, Postdoctoral Station, KEOSHER, HALAL
FAQ
As one of the leading finished dosage form manufacturers and suppliers in China, we warmly welcome you to buy finished dosage form made in China here from our factory. All customized products are with high quality and low price. For more information, contact us now.
injectable grade Tyrosine, injectable grade Proline, L Serine for Cell culture medium